Lupine Publishers | The Terrible Triad Miracle

 Lupine Publishers |  Orthopedics and Sports Medicine

Abstract

Introduction: The terrible triad injury of the elbow is a fracture-dislocation injury consisting of a radial head fracture, coronoid fracture and dislocation of the elbow. This injury is relatively uncommon and despite surgical management these injuries often go on to develop various complications.

Case Presentation: Presented is a terrible triad elbow injury of the left elbow in an 18-year-old male. The patient underwent open reduction internal fixation of the elbow and achieved exceptional outcomes. The joint was adequately stabilized through addressing the coronoid fracture and highly comminuted radial head. He was subsequently followed in clinic and placed on a conservative rehab approach.

Conclusion: Despite recent trends, the joint was aggressively stabilized, and the patient was placed through conservative rehab. In this case, the patient was able to achieve satisfactory outcomes in a short period of time.

Keywords: Elbow; Fracture Dislocation; Terrible Triad Injury Introduction

The terrible triad injury of the elbow is a fracture-dislocation injury consisting of a radial head fracture, coronoid fracture and dislocation of the elbow [1-5]. It was first described by Hotchkiss in 1996 and named so due to the poor outcomes experienced by these patients [1]. Despite surgical management these injuries often go on to develop various complications: recurrent instability, stiffness, posttraumatic arthritis, heterotopic ossification and fixation failure. This injury is relatively uncommon and studies attempting to analyze outcomes often have a low number of subjects [1]. We present a case of a terrible triad injury with exceptional range of motion outcomes within a short time frame (Figure 1 and 2).

Case Presentation

A healthy 18-year-old male presented to West Houston Orthopedics for evaluation of left elbow pain. He fell two days ago while skateboarding and was evaluated at an outside emergency department. He was diagnosed with a left elbow fracturedislocation treated at the time with reduction and splinting. At his initial orthopedic clinic visit, evaluation of radiographs revealed a reduced left elbow fracture-dislocation with a displaced, comminuted fracture of the coronoid and associated displaced, comminuted fracture of the radial head. CT scan of the elbow revealed displaced and extensively comminuted intra-articular fracture of the radial head involving at least 40-50% of the articular surface. The coronoid process was extensively comminuted with sublime tubercle involvement and likely the distal insertion of the ulnar collateral ligament (Figure 3). Mildly displaced fractures along the posterior capitellum were also identified. The patient was treated with open reduction internal fixation (ORIF) left radial head, ORIF coronoid process and lateral collateral ligament reconstruction 5 days after presentation to clinic. A single extensor digitorum communis splitting approach was used to gain access to the joint. The exposed radial head was in one large piece and several smaller pieces which included 3 pieces amenable to fixation. The anterior capsule incision was then extended to access the coronoid fracture. Fragmented cartilage pieces from the ulnohumeral and radiocapitellar joint were removed from the joint. An attempt to fixate a larger coronoid fragment was made; however, the piece further fragmented, and fixation was no longer possible. A 1.8 mm suture anchor was then placed for suture fixation of the anterior capsule following radial head fixation. The larger radial head fragments were reduced and fixated using two mini headless screws placed with compression.

The remaining coronoid fragments were removed from the joint and the Fiber Wire was used to fixate the anterior capsule to the remaining coronoid. Fluoroscopy confirmed reduction of the fracture with concentric joint reduction with the elbow flexed and supinated. The LCL was repaired using 0 Vicryl. The annular ligament was similarly repaired along the radial head and neck. Hard copy radiographs were obtained after closure and confirmed reduction of the fracture with concentric elbow joint reduction and placement of hardware. Table 1 highlights the post-operative management of this patient along with his active range of motion at each visit.

Discussion

The approach to surgical management of terrible triad injuries is still highly variable and outcomes are not well established. Giannicola et al. studied 78 elbows with complex elbow instability and found flexion, extension, pronation and supination at 3 months to be 131°, 18°, 76° and 72° respectively [2]. In a review done by Rodriguez-Martin et al. analyzing 137 elbow triad injuries from 5 studies following a protocol of fixation or replacement of radial head, fixation of coronoid fracture and repair of LCL complex, the weighted average flexion was 131.98°, extension was -16.19°, forearm pronation was 76.35° and forearm supination was 62.45° [3]. In this case, the patient was able to achieve full range of motion of his elbow at just 3 months post-op without pain or signs of heterotopic ossification. Several factors may explain the favorable outcomes: the patient was young and healthy, the anterior capsule was stabilized to the coronoid, the radial head was fixed rather than replaced and the patient was progressed cautiously with close monitoring in a hinged elbow brace. The patient was also kept in a static splint for the first month of treatment without motion or PT.

There is increasing support for active elbow motion days after surgery in order to recruit the dynamic stabilizers of the elbow [3]. The idea that the elbow should never be immobilized is often viewed as dogma [4]. In the case of this patient, a more conservative rehab approach was utilized secondary to concern that formal physical therapy might stress the fixation too soon. The patient remained immobilized until 4 weeks post-operatively, at which point a hinged elbow brace prescription was given. The hinged brace was not fully unlocked until 8 weeks post-op. Additionally, formal physical therapy was delayed because of confidence that this patient would be compliant with home exercises. Given patient compliance and close monitoring, he was given a home exercise program six weeks post-operatively and a formal physical therapy referral at eight weeks post-operatively. While there is growing consensus that the coronoid fracture should be addressed due to its role in humeroulnar sagittal stability [1-5]; Chemama et al. recommend that type 1 coronoid fractures may be neglected. In this case we opted to reinsert the capsule via anchors for improved humeroulnar joint stability [5]. In addition to coronoid stabilization, we fixated the native radial head despite it being in greater than 3 pieces. An argument can be made that fixation of the radial head should be attempted prior to replacement. Watters et al found that arthroplasty had similar results to fixation; however, they further concluded that long-term studies need to be performed to identify the impact of late complications of arthroplasty such as loosening. In a young patient, the risk of arthroplasty revision in the long run may outweigh the risks carried by fixation [6] (Figure 4). Conclusion

We report a case of a terrible triad injury in a young male who achieved an exceptional outcome despite early and extended immobilization of the joint. Despite recent trends to mobilize the joint early, the patient was able to achieve satisfactory outcomes in a short period of time. Furthermore, the joint was adequately stabilized through addressing the coronoid fracture and fixating a highly comminuted radial head.

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Lupine Publishers | The Importance of Pragmatic over Explanatory Randomised Controlled Trial in Musculoskeletal Physiotherapy Practice

 Lupine Publishers |  Orthopedics and Sports Medicine

Abstract

Depending on the choice of research methodology, there are several research designs such as a single observational case study, a cohort or case-controlled design, nonrandomised and randomised controlled trials (RCTs). While RCTs are widely considered as the gold standard for assessing the effectiveness of different physiotherapy interventions, there are two types of RCT mainly explanatory and pragmatic RCT. It is the opinion of the author a pragmatic RCT approach that not only have realistic treatment sessions but also involve less costs and personnel are best suited for musculoskeletal studies undertaken in a normal clinical environment to enhance their generalisation.

Introduction

Research evidence suggests the number of physiotherapy treatment sessions varies over treatment episodes [1], however, according to the Chartered Society of Physiotherapy [2] (CSP, 2011) the average physiotherapy (face-to-face) treatment sessions per episode of care for a patient was on average four-with a first to follow-up ratio of 1:3.4. The minimum number of physiotherapy treatments per episode was one with maximum of six treatment sessions. These figures were from the research findings of a large comprehensive review of physiotherapy outpatient services across the United Kingdom by JJ Consulting on behalf of the [2] CSP (2011). These figures are important benchmarks for Physiotherapy managers and physiotherapy service providers to them guide on staffing levels and management of caseloads to support a range of areas such as business planning, capacity and demand management, and service re-design. Thus, it is important for researchers and those funding physiotherapy researches to take into consideration the average number of treatment sessions that occurs in normal clinical practice when developing research designs that investigates the effectiveness of treatment interventions in musculoskeletal practice. This is so that the findings of such research could easily be transferable to real physiotherapy clinical situations. Pragmatic randomized controlled trials (RCTs) are designed and conducted to establish the clinical effectiveness of interventions i.e. does this intervention work under usual clinical conditions? (Tunis et al 2003 and Tunis 2005). According to [3] for a trial to fulfil the requirements of the design and conduct of a pragmatic RCT, it should have the nine dimensions for assessing the level of pragmatism in a trial. These include eligibility, recruitment, setting, and organisation, flexibility in delivery, flexibility in adherence, follow-up, primary outcome and primary analysis. Although most pragmatic RCTs follow this protocol in their design and conduct, some of them that have investigated the clinical effectiveness of interventions in musculoskeletal conditions such as low back pain (LBP) but have done so with follow-up contact of the study participants in excess of the usual practice (Table 1). Follow-up visits (timing and frequency) are pre-specified in the protocol of RCTs. However, “follow-up visits are more frequent than typically would occur outside the trial (i.e., under usual care)” [3] Loudon et al (2015) (Table 1).

Table 1: A PRECIS follow-up assessment of some trials.

Table 1 shows that in some randomised controlled trials (RCTs) on musculoskeletal physiotherapy interventions that there are difficulties with transferring the results of those trials into daily clinical practice due to their unrealistic treatment occasions. For example, an RCT [4] that was conducted to evaluate the relative efficacy of strengthening exercises versus spinal manipulation on low back pain (LBP) patients were provided a one-hour session twice per week for 6 weeks – bringing the total treatment episodes to 12 one-hour treatment sessions. Similarly, [5] Alp et al, (2014) in a RCT of management low back pain that investigated selfmanagement (unsupervised exercise) versus group biomechanical exercise used 45-60 minute, 3 times per week for 6 weeks as their treatment regime. The findings of these trials are in sharp contrast to the [2] CSP (2011) findings on the maximum number of treatments per episode care, which was six. Furthermore, anecdotal evidence suggests that initial musculoskeletal physiotherapy treatment is maximum of one hour and follow-up treatment ranges from 20- 45 minutes. The implications of the treatment regimens of both RCTs [4,5] suggests that they have unrealistic treatment occasions which cannot be transferred to practice. It is therefore imperative for clinical trials investigating the effects of physiotherapy interventions to take into consideration that study designs should mirror what occur in normal clinical practice. There are many different research designs ranging from a single observational case study, a cohort or case-controlled design, to experimental studies such as nonrandomised and randomised controlled trials (RCTs). Each design has its own strengths and weaknesses. The choice of methodology may be influenced by factors such as the research question, ethical issues, sample size and funding [6]. Although case studies are likely to demonstrate clinically significant improvement in outcomes of pain and function, it must not be forgotten that they cannot rule out the effects of natural resolution, bias and other confounders such as the real cause of the improvement (Ainsworth & Lewis 2007). However, single case studies should provide some motivation for conducting the appropriate and necessary trials such as nonRCTs and RCTs [7]. NonRCTs can detect associations between an intervention and an outcome, however they cannot rule out the possibility that the association was caused by a third factor linked to both intervention and outcome [8]. RCTs are widely considered as the gold standard for assessing the effectiveness of different interventions such as shoulder injections, because they allow us to be confident that a difference in outcome can be directly attributed to a difference in the treatments, rather than some other confounding variables (age and gender) [9,10]. However, other factors, such as patient’s clinical experience of the intervention, as well as the quality and quantity of treatment received been suggested to play a role in determining treatment outcomes [11]. Therefore, an RCT that combines these aspects by investigating the effectiveness of the interventions in real life clinical situation is important. To achieve this, RCTs investigating the effectiveness of two interventions (usual or routine versus intervention) to treatment should as part of their research methodology take into consideration the practicality of number treatment sessions, follow-up regimes and outcomes that are comparable to those observed in every day clinical practice – both in community and acute settings. This so that any treatment effect from those studies can be easily transferable to normal clinical practice situations. RCTs help to reduce the risks of bias (threats to interval validity), mostly selection bias, and are thus best suited for research designs about the effectiveness of different interventions [12]. However, it is the opinion of Cochrane, that randomisation does not, of itself, enhance the applicability of the results of a trial (external validity) to situations other than the exact one in which it was conducted [13]. It is possible for a trial to be free of bias but lacking in its application beyond the immediate clinical environment in which it was conducted [12]. This view was strongly re-echoed by [14] which it stated: “Lack of consideration of external validity is the most frequent criticism by clinicians of RCTs, systematic reviews, and clinical guidelines” [14]. To resolve this problem [12] has suggested the use of well-designed trials that adopt a pragmatic approach. Therefore, it is my opinion that for a pragmatic RCT approach to be adopted as a research design, it should have realistic treatment occasions and transferable to normal clinical environment where most people with musculoskeletal conditions are easily, are diagnosed and treated [15] to enhance its generalisation.

Pragmatic Versus Explanatory Randomised Controlled Trial

[16] describe two different types of RCT, explanatory and pragmatic. They proposed a distinction between explanatory and pragmatic trials. It is their view that many trials (such as explanatory trials) were limited in their applicability beyond the artificial, laboratory environment. Explanatory trials are aimed at validating a physiological hypothesis by specifically proving a causal relationship between administration of a treatment (a drug) and a physiological outcome (such as inflammation) [16]. Although pragmatic trials do not necessarily decrease occasions of service or necessarily curtail follow-up, they provide an explanation between interventions and treatment outcomes, and they are intended to inform healthcare decision-making. This decision involves the choice between two or more treatments occurring in real life clinical environment. On the other hand, explanatory trials provide knowledge about the effects of precisely defined interventions applied to selected groups under highly controlled conditions; however, they are not applicable in normal physiotherapy practice that lack such highly controlled environments. Pragmatic trials have been offered as a solution in that they retain the rigour of randomisation but are still applicable to normal clinical practice [17] (Relton et al 2010). It is for these reasons that musculoskeletal studies should adopt a pragmatic approach which takes into account realistic treatment occasions which occurs in a normal clinical so that findings from such trials can be easily transferable to practice. For example [18], in a pragmatic RCT that investigated exercise versus group biomechanical exercise in chronic low back patients using a one-hour session per week, which what obtains in every day, practice. The implication of this study findings is that it has realistic treatment occasion that is easily transferable to practice. The differences between the two approaches are also highlighted in the use of efficacy and effectiveness [19]. Explanatory trials deal with efficacy as these studies assess differences in effect between two or more conditions under ideal, highly controlled conditions. Although the tight controls of explanatory trials result in maximal internal validity, external validity could be lost (Alford 2007) because replicating them under normal clinical practice is difficult. Explanatory trials are thought to be well suited to medical drug trials, which are usually double or triple blinded, and involve the use of a placebo control group (Alford 2007). Pragmatic RCTs utilise effectiveness, which assesses differences in effect between two or more conditions in normal clinical circumstances, thus retaining internal validity and enhancing external validity (Alford 2007). It is the opinion of Alford (2007) that pragmatic RCTs are generally more suited to assessing musculoskeletal interventions such as exercise prescription for managing low back or shoulder pain. Explanatory trials are usually more expensive, take more time and involve more personnel, unlike pragmatic trials. These difficulties are the reasons why a pragmatic approach is best suited for musculoskeletal research within the community. The benefits are that less extra costs or personnel would involve in such studies because they are more likely to take place within normal clinical hours with the usual staff involved.

Pragmatic Randomised Controlled Trial-Why it is Important

In a normal community practice where most people with musculoskeletal pain are diagnosed and managed [15], a pragmatic RCT design is important if they have realistic treatment, occasions, which can be transferred to practice. A pragmatic RCT is aimed at determining the effectiveness of two or more interventions under the usual conditions or real-life settings in which they are applied [20]. Pragmatic trials including RCT are aimed at ensuring that the care delivered in the setting in which trials are conducted matches the care delivered in the setting to which its results are applied [3]. Pragmatic RCTs are generally linked with clinical practice and they incorporate clinical outcomes that are relevant to inform decision makers such as patients, clinicians, health commissioners and policy makers about interventions that are applicable to a wide range of clinical settings [20]. These trials adopt minimal exclusion criteria in order for the patients to reflect those receiving care within the normal population [20]. This is so that treatment interventions and decision making by both the patients and healthcare providers regarding the management of musculoskeletal conditions could be enhanced. Musculoskeletal studies should include participants drawn from a population of patients attending a community (MSK) service as they would representative of the general population. The benefits of pragmatic trials less costs and personnel because they are more likely to take place within normal clinical hours with the usual staff involved. The nine dimensions for assessing the level of pragmatism in a trial (Figure 1), as proposed in the pragmaticexplanatory continuum indicator summary 2 (PRECIS-2) tool should be adoped by musculoskeletal studies so that they can be easily transferred to practice [3]. With the current economic climate and given the pressure to improve healthcare delivery within the community, pragmatic RCTs have received widespread support and acceptance from clinicians, researchers and policy makers [21]. Healthcare commissioners and policy makers are very interested in pragmatic trials because they are designed to answer important and relevant questions, which are centred on comparative effectiveness of interventions in the normal clinical practice [22]. However, those trails should not only have realistic treatment sessions but also involve less costs and personnel. Since the local Clinical Commissioning who commissions musculoskeletal practice are interested in knowing the clinical outcomes, involving them and GPs during the planning stages of musculoskeletal research is very important. This is consistent with the suggestion by [22] that decision makers such healthcare providers and policy makers should be included in the design of pragmatic trials.

Conclusion

While RCTs are widely considered as the gold standard for assessing the effectiveness of different interventions such as shoulder injections, there are basically two types of RCT mainly explanatory and pragmatic RCT. Although each design has its own strengths and weaknesses, the choice of methodology may be influenced by factors such as the research question, ethical issues and clinical practice environment [6-31]. It is the opinion of the author a pragmatic RCT approach that not only have realistic treatment sessions but also involve less costs and personnel are best suited for musculoskeletal studies undertaken in a normal clinical environment to enhance their generalisation. For more Orthopedics and Sports Medicine Open Access Journal (OSMOAJ)

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Lupine Publishers | Laparoscopic Right Hemicolectomy and Primary Anastomosis for Tubulovillous Polyp with Preoperative Endoscopic Tattooing as A Preventive Treatment in High Risk Colorectal Cancer Patient Case Report and Review

 Lupine Publishers | Open Access Journal of Oncology and Medicine (OAJOM)

Abstract

Background

VA/TVAs are thought to be the advanced precursors in the “adenoma-carcinoma” pathway. Right-sided colon cancer accounts for approximately 30% of bowel cancer in women and 22% in men, Curative treatment for right-sided colonic cancer includes right hemicolectomy with or without adjuvant chemotherapy. We present a 43-year-old female, with history of a father who died from colon cancer, she has a history of high blood pressure, obesity, and epilepsy, presenting hematochezia. A colonoscopy was performed with evidence of a granular scattered lateral growth lesion in the ascending colon, which cannot be resected by mucosectomy, which is why an endoscopic biopsy and tattoo was performed. The result of histopathology with tubulovillous polyp without evidence of dysplasia.

Keywords: Tubulovillous Polyp; Colorectal Cancer; Endoscopic Tattooing; Hemicolectomy; Laparoscopic Surgery; Preventive Treatment

Abbreviations: CRC: Colorectal Cancer; VA/TVA: Tubular Adenomas and Villous/Tubulovillous Adenomas; SSA: Sessile Serrated Adenomas: TSA: Traditional Serrated Adenomas; HP: Hyperplastic Polyps

Introduction

It is well established that colorectal cancer (CRC) develops from a series of precursor epithelial polyps [1], which include conventional adenomas, incorporating tubular adenomas and villous/tubulovillous adenomas (VA/TVA) and serrated polyps, incorporating hyperplastic polyps (HP), sessile serrated adenomas (SSA) and traditional serrated adenomas (TSA). VA/TVAs are thought to be the advanced precursors in the “adenoma-carcinoma” pathway [2]. Risk factors include advancing age, male gender, highfat, low-fiber diet, tobacco use, and excess alcohol intake (more than eight drinks a week). Individuals with a family history of polyps, colorectal cancer, and intestinal polyposis carry a higher risk of developing colon polyps [3]. Right-sided colon cancer accounts for approximately 30% of bowel cancer in women and 22% in men [4] Curative treatment for right-sided colonic cancer includes right hemicolectomy with or without adjuvant chemotherapy [5]. Depending on the pattern of growth, these tumors can be villous, tubular, or tubulovillous. A polyp with more than 75% villous features, i.e., long finger-like or leaf-like projections on the surface, is called a villous adenoma, while tubular adenomas are mainly comprised of tubular glands and have less than 25% villous features. A tubulovillous adenoma is referred to as an adenoma with both features. Tubular adenomas are the most common type of colonic adenomas, comprising a prevalence of more than 80% [6]. Although villous adenomas are more likely to become cancerous, this reflects the fact that they generally have the largest surface area due to their villous projections. If adjusted for surface area, all types of adenomas have the same potential to become cancerous [7]. The clinical significance of polyps arises from the fact that more than 95% of colon adenocarcinoma originate from polyps. Errors in localization account for a 6.3% rate of alteration in preoperatively colonic resection [8], endoscopic localization is highly inaccurate, with a 21% rate of error endoscopic tattooing is an alternative, although different techniques are used for tattooing, it is important to be consistent in the pattern of marking and to clearly document the method in the colonoscopy report. The authors recommend that tattoo be placed in 3 separate areas around the circumference of the lumen distal to the lesion [9]. Right colectomy is the procedure recommended for tumors proximal to the proximal transverse colon. Principles of right-sided resection include abdominal exploration for distant disease, mobilization and medialization of the right colon and hepatic flexure to allow for resection and anastomosis, and high ligation of the ileocolic pedicle and right branch of the middle colic artery [10] obtaining better post-surgical results with a minimally invasive and preventive approach.

Materials and Methods

We present a 43-year-old female, with history of a father who died from colon cancer, she has a history of high blood pressure, obesity, and epilepsy, presenting hematochezia. A colonoscopy was performed with evidence of a granular scattered lateral growth lesion in the ascending colon, which cannot be resected by mucosectomy, which is why an endoscopic biopsy and tattoo was performed (Figure 1). The result of histopathology with tubulovillous polyp without evidence of dysplasia. A preoperative protocol is started based on abdominal tomography and preoperative laboratories, with no evidence of alterations.

Results

Performing pneumoperitoneum at 15mmHg, a diagnostic laparoscopy is started, the ileocecal valve is identified , an opening of the meso in the terminal ileum is performed at 10 cm from the valve, sectioning with a 60 mm endoGIA stapler, opening the right TOLD fascia, and subsequent opening of the right mesocolon with a 5 mm ligasure, with adequate identification of the right colic artery, the hepatic angle of the colon is released until the endoscopic tattoo is identified and the transverse colon is sectioned using an endoGIA stapler 60 mm 7 cm distal to the tattoo. The serous plane of the terminal ileum and transverse colon is faced laterally with 2-0 silk, a 1 cm opening is made in the distal portion of the ileum and colon, through which a 60 mm endoGIA stapler is inserted and stapling is performed, to perform side-to-side anastomosis, closure of the anastomosis with 2-0 prolene with continuous surjete, surgical piece is extracted by port in the left hypochondrium, 2 drains are left and closed by planes (Figure 2). At 24 hours after surgery, the patient had no abdominal pain, no bloating, nausea, or vomiting. The drains with little serohaematic expenditure, the patient is left fasting for 4 days and on the 5th day an intestinal transit is carried out with a water-soluble medium without evidence of leaks (Image 4), starting a progressive liquid diet and discharging from the hospital on the 6th day without incidents or accidents (Figure 3).

Discussion & Conclusion

A standardized approach to endoscopic tattooing will avoid confusion for the surgeon at the time of laparoscopy. This is crucial to help provide the best oncologic resection for the patient. Endoscopic tattooing is a well-known technique and helps to obtain better pre and post-surgical results with minimal invasion, however it is important to know the guidelines for the correct performance of this technique as well as take it into account to offer to patients in whom injuries are identified risk as well as concomitant hereditary factors an alternative of minimally invasive resection adequately delimiting the margins of the lesion with a faster recovery while preserving the safety of the procedure as it was presented in the case of our patient. Considering these strategies and the individualization of each patient, potential risk factors as well as clinical presentation as a therapeutic and preventive opportunity for colorectal cancer.

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Lupine Publishers | Immunotherapy in lung cancer in times of the COVID-19 pandemic

Lupine Publishers | Open Access Journal of Oncology and Medicine (OAJOM)

Abstract

The current pandemic due to COVID-19 has become a dilemma in decision-making in clinical oncology. On the one hand, the mortality associated with this viral infection is significantly higher in patients with cancer, especially in lung cancer. On the other hand, it is well-known that immunotherapy (PD-1 blockade) improves survival in advanced lung cancer. In the present view point, we aim to clarify the procedure to follow in the context of this pandemic. We conclude that immunotherapy does not increase the risk of serious events produced by COVID-19 in patients with lung cancer. Then, immunotherapy should not be delayed or stopped in patients with lung cancer in times of viral pandemic.

Keywords: Immunotherapy; PD-1 Blockade; Pandemic; COVID-19; Lung Cancer

Introduction

In the context of the current COVID-19 pandemic, a significant part of the medical community has taken the decision to postpone or suspend oncology therapies with clinical benefit. Here, clinical benefit should be understood as therapies which improve the quality of life and survival in cancer patients. For instance, in a prospective study in patients with lung cancer but negative COVID-19 (n = 211), the corresponding palliative therapy was delayed (interrupted) in the 39.7% (3%) of cases [1]. At the beginning of the pandemic, we may understand this kind of decision due to the insufficient knowledge about the virus behavior in cancer patients. Today, almost one year after the onset of the viral infection, knowledge about this issue has drastically increased.

The Dilemma is the Following

a) The COVID-19 infection significantly increases mortality in cancer patients. Especially in cases of lung cancer. A systemic review (n = 52 studies with 18,650 cases) reveals that patients with cancer and COVID-19 infection have a higher mortality than the COVID-19 infected population without cancer (mortality of 25.6%). Cancer is an independent risk factor for mortality (especially hematologic malignancies and lung cancer). Other risk factors are age, the male gender, the black race, current smoking habit, and comorbidities [2]. b) The immunotherapy (PD-1 blockade) significantly improves survival in advanced lung cancer patients [3, 4]. Taking into account the clinical benefit of PD-1 blockade and the COVID-19 scenario, the question to be faced is the following: Should immunotherapy be postponed or stopped in patients with advanced lung cancer? The answer to this question is of utmost importance because it allows us to make a decision in routine oncological practice. This decision will have a direct impact on the morbidity and mortality of this type of patients. The article “Impact of PD-1 Blockade on Severity of COVID-19 in Patients with Lung Cancers” concludes that in patients with lung cancer and positive COVID-19 (through RT-PCR in nose or throat smears), the use of PD-1 blockade, before the diagnosis of viral infection, does not increase the risk of severe events produced by COVID-19. There was also no significant difference in serious events produced by COVID-19 in patients with lung cancer in relation to those with recent or past exposure to immunotherapy [5].

The Limitations of the Article are the Following

a) Retrospective study b) Single-center study c) Small sample size (n = 69 cases) d) The short follow-up from diagnosis of COVID-19 (14 days).

The Strengths of the Article are

a) The study was approved by an ethics committee b) The primary question of the study was defined (the impact of PD-1 blockade on severity of COVID-19 in patients with lung cancer) c) Diagnosis of COVID-19 infection by laboratory test considered the gold standard d) Exclusion of suspected but unconfirmed cases e) Suitable definition of what is a serious event by COVID-19 f) Appropriate methodological design g) Risk factor adjustment for severe event produced by COVID-19 in lung cancer (smoking status and gender) h) Various data sources were used i) The data record was exhaustive j) Expert human resource in data collection was used k) An independent reviewer was used to give more reliability to the data collection l) Correct statistical analysis m) Updated and relevant bibliographic support n) The primary question of the study was answered According to our analysis, the strengths of this study are greater than its limitations. Therefore, the conclusion of the article is valid. However, a valid conclusion is not necessarily sufficient for decision making.

We Consider that the Mentioned Conclusion is not Sufficient Mainly Because

a) The analyzed article does not have enough statistical weight (the sample size is limited, n = 69) b) And the study is a retrospective one

As a Result, we Should Complement the Discussion

The article “COVID-19 mortality in patients with cancer on chemotherapy or other anticancer treatments: a prospective cohort study” is a prospective observational study (n = 800 cases), which considers cancer patients who test positive for COVID-19. After adjusting for other risk factors, there was no significant increase in mortality between the group that received immunotherapy within 4 weeks of the diagnosis of COVID-19 versus the group that did not receive this treatment [6]. Thus, based on the best available evidence, we conclude that the immunotherapy (PD-1 blockade) in lung cancer should not be postponed or suspended because it does not increase critical events due to the COVID-19 viral infection. Postponing or suspending immunotherapy would increase morbidity and mortality from lung cancer. However, it should not be forgotten that we must strictly maintain the safeguard measures to reduce the risk of contagion.

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Lupine Publishers | Application of Autologous Platelet Rich Plasma to Graft Donor Sites to Reduce Pain and Augment Healing: A Randomized Controlled Trial

  Lupine Publishers |  Orthopedics and Sports Medicine

Abstract

Introduction

Platelet Rich Plasma has been vastly utilized in the medical field due to its property to heal the wounds and the multitude of growth factors it contains. Traditionally, donor sites are left to heal with a primary dressing which would otherwise be opened as the wound heals. Various methods of donor site management have been described such as collagen dressings, hydrocolloid, alginate, hydro fiber, silicone dressing, or paraffin gauze. However, it is often encountered that there is a delay in the healing process and accompanied by pain at donor site. Furthermore, in a relatively small population of patients who have a tendency to hypertrophic scar formation, this becomes a challenge for the plastic surgeon. It not only leads to unsightly scars but also additional problems of dryness and itching. Owing to the healing properties of PRP, we designed this study to utilize it for donor site dressings following split thickness skin grafts. This study primarily throws light on the usage of Autologous PRP over Split thickness Skin Graft donor sites to augment healing, and reduce pain.

Materials and Methods

The 100 patients enrolled in this study between January 2018- July 2019 were divided into two groups of 50 each on a randomized basis, one of which was subjected to use of Autologous PRP, which was topically applied at the donor site and the other control group where the wound was traditionally dressed. Pain scales were measured in the immediate postoperative period as well as at the time of first dressing. Dressing was opened on the 14th postoperative day and observed for healing.

Results

Patients with the PRP group showed statistically significant faster healing at the 14th postoperative day, as compared to the control group which required continuing dressing 3-4 weeks. We also measured pain scale in the postoperative period and at the time of first dressing, which was significantly less in the PRP group. It’s worthy to mention that a few of the patients who has hypertrophic scars previously, did not develop after the application of PRP.

 

Conclusion

 

Application of PRP is a safe, cost effective, easy method to achieve faster healing in graft donor site areas, which is more often than not bothersome to the patients undergoing split thickness grafts. It also reduces the postoperative pain at the donor site. We recommend its use more frequently in managing donor site for Split thickness skin grafts.

Keywords: PRP; Donor Site; Pain; Skin Grafts; Wound Healing

Introduction

Split thickness skin graft is a widely accepted technique to cover large defects. However, it is often encountered that there is a delay in healing process, which may further lead to problems such as pain, infection and hypertrophic scar formation. Autologous PRP has been used in various treatment modalities in the field of plastic surgery for its healing, adhesive and hemostatic properties owing to the growth factors that are released. Platelet-rich plasma (PRP) is an autologous product that concentrates a large number of platelets in a small volume of plasma [1]. PRP also provides an immediate surgical hemostatic agent that is biocompatible, safe, and effective. The platelet comprises granules which are released when PRP is applied to the surface. These granules have properties which:

 

• Accelerates endothelial, epithelial, and epidermal regeneration

• Stimulates angiogenesis

• Enhances collagen synthesis

• Promotes soft tissue healing

• Decreases dermal scarring

• Enhances the hemostatic response to injury

 

Another concern about PRP is its method of preparation. Although a lot has been written about methods of preparing PRP, there is still confusion over terminology to classify and describe the different variations of platelet concentrations. There are several ready to use commercial devices available, which make preparation of PRP simple and easy. However, they add to the costs of treatment. They are usually able to achieve a concentration of 2-5 times above baseline. Higher Platelet count above this has not shown to cause any additional benefits contrary to the assumptions; in fact concentration of PRP above 2.5 has been shown to be detrimental[4]. Marx proposed that platelet count of 10 lakh/ml in 5 mL of PRP, as a working definition of PRP, based on the scientific proof of bone and soft tissue healing enhancement [13].Rughetti et al.[14] found that the stimulation for proliferation of endothelial cells peak at 1.25 × 106 and angiogenesis at 1.5 × 106 platelets/ mL, respectively. This signifies the fact that a PRP platelet count 1 million/mL has become the working definition for therapeutic PRP. We have our own institutional method of preparing PRP which has been rectified by our labs to achieve a high platelet concentration.

In view of the properties of PRP, we have theorized its use to be expanded in donor site dressings which has been a point of concern for a long time for both patients and treating physicians. In this study we have demonstrated how application of PRP aids in donor site healing. We have also shown that it reduces pain in the immediate postoperative period. The application of autologous Platelet-Rich Plasma (PRP) to STSG application sites has been recently described and theorized to help in faster healing and treatment of hypertrophic scars.

 

 

Materials and Methods

The study was performed in the Department of Plastic, Reconstructive and Burns Surgery, SMS Hospital, Jaipur between 2018-2020. We obtained a sample size of 100 using our institutional software to make the study statistically significant in view of the previous studies involving use of PRP for various treatments. The 100 patients taken into the study with written and informed consent were randomly divided into two groups of 50 each in cases and controls. Sealed envelopes containing a number indicative of the group assignment (even number = Cases, uneven = Controls) were used to randomly allocate patients into two groups in the operation theatre. 100 envelopes were prepared in this manner and the patients were blinded to the treatment. All the patients gave consent to be a part of this trial as well.The patients in the cases group were subjected to use of PRP at the donor site followed by the standard paraffin gauze dressing. In the patients of the control group, the donor site was managed simply by paraffin gauze dressing without the use of PRP.Intraoperatively, fentanyl in a dose of 1ug/kg was given as a pain medication and postoperatively no pain medication was administered until the patient complained of pain. If he did complain of pain a rescue drug Inj. Diclofenac in a dose 1mg/kg was given. All patients with wounds that required split thickness skin grafting were included in the study. To be a part of the study the patient had to fulfill the following inclusion criteria

 

Inclusion Criteria

 

• All patients which required harvesting of split thickness skin graft

• S. Albumin above 2.5 g/dl

The following patients were excluded from the study

 

Exclusion Criteria

 

• Active Infection

• Age >70 years

• Pus, discharge

• Immunocompromised patients

• Exposed ligaments/ bone/cartilage

• Underlying Comorbidities uncontrolled hypertension, uncontrolled diabetes and renal disorders

• Uncooperative Patients

• Drug Abuse

 

Our Method of Preparing Prp

 

• Patients venous sample was taken

• Blood Collected in 10 ml ACD vials

• The vials were spun for 5 mins at 1500 rpm (Soft Spin) after which the supernatant was spun at 3500 rpm (Hard Spin) for 15 mins.

• PRP is spread as a thin film over the area using a syringe with a 24 gauge needle

• 5 ml for 100 square cm was used.

 

Post-Operative Care

 

Dressing was opened on the 14th Postoperative day to assess for healing and pain by an independent observer thereby masking the treatment allocation. The wound was said to heal well if on inspection there was complete epithelization of the donor site characterised by healthy pink tissue, there was no residual raw area or any signs of infection.

Next follow up was done on the 21st day.

 

Primary Outcome

 

• Donor site healing on 14th post-operative day • Pain scale in the postoperative period at 6,10 and 16 hours and on the 14th day at the time of dressing.

• A paired T test was used as a tool to assess the test of significance.

• All patients adhered to follow up protocols as designed in our study.

 

 

Results

The wound healing was assessed by an independent observer at the time of the first dressing. The wound was said to heal well if on inspection there was complete epithelization of the donor site characterised by healthy pink tissue, there was no residual raw area or any signs of infection. 48 out of 50 patients had good wound healing on the 14th post operative day. In other two patients we required more dressings. The first of these was a 60 year old male with no other comorbidities who underwent grafting for post traumatic ulcer on foot. The other patient was a 55 year old male with traumatic ulcer over knee. In both these patients we required 3 additional dressings before the wound completely healed. (Table 1) shows the wound healing in both cases and controls on the day 14th post operatively. A paired T Test was applied to assess this where in a p value of <0.005 was obtained. It was observed that the patients in the PRP group had significantly higher fasted wound healing rates as compared to the controlled group.

 

Assessment of Pain Control

Pain at the donor site was measured at 6, 10, 16 hours post operatively by the use of VAS Scales. Further, pain was also measured at the time of first dressing. (Table 2) depicts the Mean VAS Scores at the defined intervals. Paired T test was used to define the test of significance and It was observed that the Mean VAS Score was significantly lower with a p value <0.05 at 6 hours in the Cases group. At 10hours and 16 hours the VAS Scores were similar. The Pain scores were also significantly less at the time of first dressing with a p value <0.045. (Table 2) and (Figure 2)depict Mean VAS Scores in two groups. (Figure 1) depicts pain and healing on the day of first dressing.

Discussion

PRP is defined as a biological product derived from patients own blood with the concentration of platelets above the baseline [2]. PRP has been known to have many benefits which help early vascularisation by delivering these growth factors and increasing collagen synthesis. There are other benefits like reduced hematoma, infection, and cost. Donor site care with dressing material should provide optimum healing, be cost effective and should prevent complications such as pain, infection, discomfort and scarring. It is often encountered that patients feel more pain at the donor site as compared to the recipient wound bed[3,4,5]. There have been a variety of dressings and devices that are available in the clinical practice. However, there is no single dressing that is devoid of complications or can address to all the necessary problems with donor sites. This has led to variations in choice of dressing or topical agents used by health care professionals. [6,7,8]. Gibran et al conducted a study on forty post burn patients in which they used PRP as a wound adhesive for fixing of grafts over wound beds comparing it to traditional methods like sutures and staples. [9] Schade and Roukis found PRP enhances wound healing time by releasing the growth factors it contains. [10] Kakudo et al. published a study which proved that PRP helps in revealed that PRP epithelialization and angiogenesis of graft donor sites [11]. There are many other studies that have been conducted which demonstrates that PRP aids healing and reduces pain providing growth factors to the local site. In that view this study was conducted to overcome these problems at graft donor sites.

Various methods have been described to prepare PRP. Use of different compounds in vials has also been described. In a recent study, Wanden-Berghe et al. found accelerated wound healing in chronic wound beds by PRP activated by calcium chloride [12]. In our center, after taking the venous sample in ACD tubes there are two cycles of centrifugation. The first spin step is performed at constant acceleration to separate RBCs from the remaining whole blood volume. After the first spin step, the whole blood separates into three layers: an upper layer that contains mostly platelets and WBC, an intermediate thin layer that is known as the buffy coat and that is rich in WBCs, and a bottom layer that consists mostly of RBCs. For the production of PRP the upper layer and superficial buffy coat are transferred to an empty sterile tube. The second spin step is then performed. The upper portion of the volume that is composed mostly of PPP (platelet-poor plasma) is removed. Pellets are homogenized in the lower 1/3rd (5 ml of plasma) to create the PRP (Platelet-Rich Plasma).The platelet concentrations have been classified into Low with a count of 0.5 x million/μl, Intermediate having 0.5-3 x million/μl and High with 3-5 x million/ μl. We have been able to achieve high concentration of platelets by our technique of preparation. We observed that the problem of prolonged dressings and donor site pain for which there was no definite solution. Keeping that in mind and with the proven properties of PRP, this study was conducted. It has been observed that there was significantly faster healing rates and that the donor site in most of the cases had healed when the dressing was opened on day 14. We observed that our study showed lower pain scales at 6 hours. At 10 and 16 hours the similarity in pain scales was due to the rescue medication which was given to patients that complained of pain. Pain scales were also significantly lower on the day of first dressing in coherence with Previous studies that correlate regular application of PRP with pain reduction during gauze changes [15,16,17,18,19,20]

We also followed up 8 patients (5 in PRP group and 3 in Control group) who had history of hypertrophic scar formation in donor sites. It was observed that patients in PRP group did not develop Hypertrophy in donor sites as compared to the control group where hypertrophy occurred at the end of 1st year. Although no statistical analysis was done on these patients we found it worthy enough for its mention and that a study could be done to prove this hypothesis.

Conclusion

Application of PRP is a safe, cost effective, easy method to promote faster healing in donor site areas from where split thickness skin grafts have harvested. It also reduces the postoperative pain at the donor site. We recommend its use more frequently in managing donor site for split thickness skin grafts.

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