Porcine Xenograft Versus Second Intention Healing: a Randomized, Evaluator-blinded Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Northwell Health
- Enrollment
- 14
- Locations
- 3
- Primary Endpoint
- Patient and Observer Scar Assessment Scale (POSAS) Observer Scale Total Score
Study Overview
Brief Summary
The purpose of this research study is to test whether it is better to allow patients with post- operative wounds on the legs to heal on their own without a covering or to use a porcine xenograft (skin graft that is made from pig cells) to cover the wound during healing. It is currently not known which option is better in terms of the appearance, complication rate or the impact on the patient's quality of life during the healing process. In this location, it is common receive either treatment.
Detailed Description
Porcine xenograft has been used as a barrier to the skin for over 30 years, and due to its wound healing promoting factors, we believe that its use may result in decreased healing time, smaller scar size, better cosmetic outcomes, lower pain levels, and decreased rates of infection and other post-surgical complications.
Upon completion of dermatologic surgery following standard procedures, patients will be randomized into one of two groups (porcine xenograft placement or second intention healing). Weekly follow-up via questionnaires will be conducted as well as a final office visit follow-up at 3 months.
The application of porcine xenograft dressings for wound healing was first studied in 1985, with evidence supporting several benefits when compared to traditional dressings [1]. Subsequent studies have substantiated the use of this dressing for a variety of clinical settings [2,3].
The EZ-DERM™ porcine xenograft is a biosynthetic dressing made from porcine collagen containing aldehyde crosslinking [1,3]. It has been most commonly applied to the management of 2nd degree burns, both partial-thickness and full-thickness defects [4]. This dressing can be used for two healing purposes, either for primary healing or as an intermediate in the preparation for a skin graft [2].
Compared to other biosynthetic dressings, porcine xenografts afford longer wound adherence and can be stored at room temperature [1]. The xenograft triggers rejection by the surgical defect, increasing local vascularization [5]. It also allows for rapid granulation, a reduced risk of infection, as well as reduced wound-related fluid and thermal losses [6-8]. There is also evidence that the quicker wound healing reduces the frequency of dressings, hospitalization time, pain, and analgesic [9,10].
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The evaluator will not have knowledge of or access to the intervention that was performed and represents a provider not involved in the surgical care of the patient.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Over 18 years of age
- •Able to give informed consent themselves
- •Willing to return for follow-up visits
- •Post-operative defects greater than 8 mm (in greatest diameter or length of circular or oval geometric shape) on the lower extremities (including the feet)
- •Single defect
Exclusion Criteria
- •Mentally handicapped
- •Unable to understand written and oral English
- •Incarceration
- •Under 18 years of age
- •Unwilling to return for follow-up
- •Pregnant women
- •Wounds less than 8 mm in length
- •Wounds on the head, neck or digits
- •Patients in which primary linear closure is recommended
Outcomes
Primary Outcomes
Patient and Observer Scar Assessment Scale (POSAS) Observer Scale Total Score
Time Frame: Between 2.70 to 8.75 months
The primary outcome will be the total score of the POSAS observer scale, assessed at the 3-month (+/- 1 month) follow-up visit by two blinded evaluators who will not be involved in the placement of the porcine xenograft. For each patient, scores from the two blinded investigators will be combined by calculating the mean. The POSAS (Patient and Observer Scar Assessment Scale) is a validated assessment tool used for the assessment of all types of scars by professionals and patients. The observer scale is comprised of 6 items (vascularity, pigmentation, thickness, relief, pliability, and surface area) scored on a scale from 1("like normal skin") to 10 ("worst scar imaginable"). The total score is calculated as the sum of the six items (range, 6-60).
Secondary Outcomes
- Post-operative Bleeding Requiring Physician Intervention(3 months)
- Ratio of Scar Size to Initial Defect Size(3 months)
- Number of Weeks With Pain Score Above 1(3 months)
- Pain Score at 1 Week Following Surgery(1 week)
- Number of Participants With Infection(3 months)
- POSAS Patient Scale Total Score(3 months)
- Healing Time(Up to 38 weeks)
- Pain Score of 6 or Higher at One Week(1 week)
Investigators
Victoria Sharon
Director - Dermatologic Surgery & Dermato-Oncoly, Department of Dermatology, North Shore University Hospital
Northwell Health