Acellular Fish Skin Graft use for Diabetic Lower Extremity Wound Healing

A Retrospective Study of 58 Ulcerations and a Literature Review

Shannon Michael, DPM; Christopher Winters, DPM; Maliha Khan, DPM

Disclosures

Wounds. 2019;31(10):262-268. 

In This Article

Materials and Methods

Retrospective study A retrospective, nonblinded evaluation of DFU healing with acellular fish skin graft application between January 1, 2014, and December 31, 2017, was performed.

The St. Vincent Hospital Institutional Review Board (Indianapolis, IN), in collaboration with the American Health Network of Indianapolis, approved collection of deidentified patient information to be stored securely on REDCap (Vanderbilt University, Nashville, TN).[12] Patients were included in the study if they had diabetes and more than 18 years of age, had a history of an acellular fish skin graft application to a full-thickness DFU (distal to the ankle malleoli), and were followed until the wound healed or for 16 weeks. Data were obtained for 51 patients by the principal investigator. Patients were excluded if the wounds were partial thickness or not followed for a full 16 weeks.

Patient charts were reviewed starting with their first presentation of the treated wound. The initial application of the acellular fish skin graft was recorded along with the wound's progress through 16 weeks post graft application. A deidentified spreadsheet was utilized to record data, which was stored on REDCap. The data sheet included wound location, classification (Wagner grade), duration, and size as well as use of offloading at each visit. Additional information recorded included gender, age, comorbidities, vascular status, and hemoglobin A1c (HbA1c). Vascular status was evaluated first by palpation of the dorsalis pedis and posterior tibial pulses. Pulses then were recorded as either palpable or nonpalpable. If nonpalpable, then ankle-brachial index (ABI) results were obtained and evaluated. The ABI results were deemed abnormal if the radiology report specifically stated they were abnormal. Additionally, charts were evaluated for HbA1c levels to provide an indication of diabetes control.

The included patients had recommended follow-up appointments every 1 to 2 weeks with wound measurements obtained at each visit; however, due to the retrospective nature of the study, adherence was not enforced. Patients were not excluded from the study if their suggested 1- to 2-week appointments were missed; however, they were excluded if they did not follow-up at 16 weeks. The broad inclusion criteria allowed for a realistic study population. Wound measurements (length, width, depth) were obtained and recorded only by the principal investigator.

Wound graft application was completed according to local standard of care. Each target wound was thoroughly debrided of nonviable soft tissue and then measured. Next, a piece of acellular fish skin graft was applied to the wound bed and followed by application of a nonadherent dressing (ADAPTIC TOUCH Non-Adhering Silicone Dressing; KCI, an Acelity Company, San Antonio, TX). Wound healing was defined as complete epithelialization of the wound and deemed as such by the principal investigator. Based on these measurements, the surface area of the wound was calculated from length multiplied by width (cm2).

Wound healing rates were calculated by normalizing the wound area at initial graft application to a value of 100%. The rel. wound area was then calculated at each visit using the Formula to allow for analysis of wound healing rates throughout the study, which was the same method Trinh et al[13] utilized to evaluate wound healing rates.

Systematic Review

The authors conducted a literature search on PubMed using the following terms: piscine acellular dermal graft, acellular fish skin, and fish skin graft. Articles were restricted to only those published in the English language before December 31, 2017. No additional restrictions were applied. The reference lists from the identified studies then were evaluated to locate additional articles. Researchers reviewed the articles for appropriateness; unanimous agreement was a requirement for final inclusion. The studies were graded according to the American College of Foot and Ankle Surgeons' Levels of Clinical Evidence Guidelines (LOE). Data obtained from the literature were compiled in a table to include the following: author, publication date, LOE, methods, number of participants, results, and conclusions.

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