Fish skin grafts compared to human amnion/chorion membrane allografts: A double-blind, prospective, randomized clinical trial of acute wound healing.

To access publisher's full text version of this article, please click on the hyperlink in Additional Links field or click on the hyperlink at the top of the page marked DownloadChronic, nonhealing wounds consume a great deal of healthcare resources and are a major public health problem, associated with high morbidity and significant economic costs. Skin grafts are commonly used to facilitate wound closure. The grafts can come from the patient's own skin (autograft), a human donor (allograft), or from a different species (xenograft). A fish skin xenograft from cold-water fish (Atlantic cod, Gadus morhua) is a relatively recent option that shows promising preclinical and clinical results in wound healing. Chronic wounds vary greatly in etiology and nature, requiring large cohorts for effective comparison between therapeutic alternatives. In this study, we attempted to imitate the status of a freshly debrided chronic wound by creating acute full-thickness wounds, 4 mm in diameter, on healthy volunteers to compare two materials frequently used to treat chronic wounds: fish skin and dHACM. The purpose is to give an indication of the efficacy of the two therapeutic alternatives in the treatment of chronic wounds in a simple, standardized, randomized, controlled, double-blind study. All volunteers were given two identical punch biopsy wounds, one of which was treated with a fish skin graft and the other with dehydrated human amnion/chorion membrane allograft (dHACM). In the study, 170 wounds were treated (85 wounds per group). The primary endpoint was defined as time to heal (full epithelialization) by blinded assessment at days 14, 18, 21, 25, and 28. The superiority hypothesis was that the fish skin grafts would heal the wounds faster than the dHACM. To evaluate the superiority hypothesis, a mixed Cox proportional hazard model was used. Wounds treated with fish skin healed significantly faster (hazard ratio 2.37; 95% confidence interval: (1.75-3.22; p = 0.0014) compared with wounds treated with dHACM. The results show that acute biopsy wounds treated with fish skin grafts heal faster than wounds treated with dHACM.Icelandic Technology Development Fun

Cost Effectiveness of Fish Skin Grafts Versus Standard of Care on Wound Healing of Chronic Diabetic Foot Ulcers: A Retrospective Comparative Cohort Study

Health care policy decision makers seek the highest quality products at the lowest cost for their patients. Cost-benefit analysis is a helpful tool and can be used together with other sources of information to ensure the most efficient use of medical resources. The objective of this retrospective comparative cohort study is to evaluate the cost effectiveness of fish skin therapy compared with standard of care (SOC) on chronic diabetic foot ulcers (DFUs). Retrospective patient data collected in a single wound care setting from 2014 to 2017 were included. In total, 59 DFUs treated with fish skin were used to calculate transition probabilities for a Markov model in which a hypothetical patient cohort treated with fish skin was compared with an identical hypothetical patient cohort treated with SOC. Cost was from the perspective of the payer, and the time horizon was set at 1 year. The model indicated that fish skin treatment could result in lower costs ($11 210 vs.$15 075 per wound), more wounds healing (83.2% vs. 63.4%), fewer amputations (4.6% vs. 6.9%), and a higher quality of life (0.676 vs. 0.605 quality-adjusted life year [QALY]) than the SOC. A probabilistic sensitivity analysis, based on a Monte Carlo simulation, indicated that the fish skin treatment (on DFUs) would be 93.6% likely to be cost effective for a willingness to pay at $100 000 per QALY and 71.4% likely to be cheaper than SOC. Including fish skin grafts in the SOC for DFU treatment has the potential to reduce costs while improving patient outcomes

A dual compression system: Preliminary clinical insights from the US

There is growing evidence on an interconnection between the venous and lymphatic systems in venous leg ulceration, and the possible effects of prolonged oedema and lymphatic impairment in delayed wound healing. Compression therapy is a widely accepted treatment for venous and lymphatic disorders, as it decreases recurrence rates and prolongs the interval between recurrences. Compression bandages improve venous return, increase the volume and rate of venous flow, reduce oedema and stimulate anti-inflammatory processes. The pressure at the interface (IP) of the bandage and the skin is related to the elastic recoil of the product used and its resistance to expansion. The pressure difference between the IP in the supine and standing positions is called the static stiffness index (SSI). Elastic materials provide little resistance to muscle expansion during physical activity, resulting in small pressure differences between resting and activity, with an SSI \u3c10mmHg. Stiff, inelastic materials with a stretch of \u3c100% resist the increase of muscle volume during physical activity, producing higher peak pressures, an SSI of \u3e10mmHg and a greater haemodynamic benefit than elastic systems. UrgoK2 is a novel dual-layer high-compression system consisting of an inelastic (short stretch) and elastic (long stretch) bandage, resulting in sustained tolerable resting pressure and elevated working pressures over extended wear times. It is indicated for the treatment of active venous leg ulcers and the reduction of chronic venous oedema. Each bandage layer has a visual aid to enable application at the correct pressure level. Published European studies have assessed this compression system, exploring its consistency of application, tolerability and efficacy. This article presents the first reports of health professionals\u27 clinical experience of using the compression system in the US, where it has been recently launched. Initial feedback is promising

Consensus recommendations for optimizing the use of intact fish skin graft in the management of acute and chronic lower extremity wounds

BACKGROUNDSince 2017, the clinical use of IFSG has increased substantially in the United States, with some use in Europe and Asia as well. However, scant consensus data have been published on such use.OBJECTIVEThe authors sought to develop consensus recommendations for the clinical use of IFSG in the management of acute and chronic LEWs.METHODSA panel of 8 expert clinicians in the United States used a 2-cycle NFG process to develop consensus statements based on their own clinical practice and the literature. At their initial meeting in October 2021, panel members discussed the management of DFUs, VLUs, atypical LEWs, and traumatic LEWs in their practices. Consensus statements were drafted, voted on, and rated by relative importance. At the second meeting in October 2022, the panel discussed the initial survey results; a second survey was conducted, and panel members revised the recommendations and indicated the relative importance of each in the final report. A systematic literature review of English-language articles published from January 2016 through November 2022 was conducted as well, using the search terms: "fish skin," "piscine graft," "fish tissue," "intact fish skin graft," "Cod skin," "Omega 3 fatty acid graft."RESULTSForty-three statements were generated and grouped into 5 sections comprising general recommendations for LEWs and recommendations specific to DFUs, VLUs, atypical LEWs, and traumatic LEWs. The primary general recommendation is the need to determine wound etiology based on clinical evaluation and reviewing related test results. For DFUs and VLUs, the main recommendations are to adhere to first-line therapy (ie, standard of care, follow conventional guidelines [multilayer compression therapy], offloading, and assessment of wound perfusion) before introducing IFSG.CONCLUSIONSPublications on and clinical experience in the use of IFSGs have increased substantially in the past several years. The 43 consensus recommendations are meant to guide physicians in the optimal use of IFSG in the management of acute and chronic LEWs

A Standardized Approach to Evaluating Lower Extremity Chronic Wounds Using a Checklist

As the population ages and more people live with diabetes, obesity, and vascular disease, chronic wounds have become more prevalent. Increasingly, wound care falls into the hands of clinicians who may be new to the specialty. To facilitate a better understanding of wounds and to ensure all integral items for best outcomes are considered, an interprofessional panel of wound care experts developed a checklist to aid in lower extremity wound identification, assessment, evaluation, and potential complication recognition. This checklist focuses on an evidence-based approach to obtaining a medical history, evaluating the wound, determining the etiology, and assessing perfusion, edema, infection, and neurologic status. The goal of this fundamental evaluation tool is to help the clinician move towards the next steps in optimizing patient care. Evidence-based support for each item on the checklist is reviewed and detailed for clinician reference