A Comparison of OASIS Wound Matrix With Approved Dressings for Skin Graft Donor Sites

Study Overview
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Brief Summary
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The investigators objective is to compare OASIS wound matrix with other commonly used dressings available for the donor site in split thickness skin grafting in order to determine which dressing provides the best outcome based on pain level, time to healing and aesthetic outcome.

Detailed Description
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Investigators seek to compare Oasis wound matrix with Tegaderm and Xeroform in order to determine whether advantages exist in one or more of the dressing types that are approved and currently used for split-thickness skin graft donor site dressings. Patients will be randomly assigned to one of the three treatment groups and followed up post-operatively and treated as per current standard of care. Data to be collected and analyzed includes: patient age, co-morbid illnesses, medication, skin-graft donor location, skin-graft donor area, STSG thickness, infection rate, complications involving the donor site, post-operative pain score every morning until hospital discharge, healing rate, photographs of the donor site immediately post-operatively and then at routine follow-up appointments.

Official Title
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A Comparison of OASIS Wound Matrix With Approved Dressings for Split Thickness Skin Graft Donor Sites

Conditions
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Skin Graft Complications

Intervention / Treatment
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* Other: Tegaderm™(Absorbant, 3M)
* Device: OASIS® wound matrix
* Other: Xeroform™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients scheduled to undergo split thickness skin grafting patients able to consent without a proxy Exclusion Criteria: confounding medical conditions previous skin grafting from site prior use of biological skin substitute on site

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OASIS® wound matrix<br>OASIS wound matrix is a biologic extracellular matrix derived from porcine small intestine submucosa. Some components of OASIS wound matrix are similar to human dermis including types of collagens, elastin, glycoproteins and proteoglycans. In addition, OASIS wound matrix retains some growth factors that have been suggested to aid in the wound healing process. It is a FDA approved wound dressing indicated for use in a variety of ulcers, abrasions and surgical wounds. | Device: OASIS® wound matrix<br>* OASIS® Matrix is indicated for the management of wounds including: partial- and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), draining wounds, surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence).<br>|
| Active Comparator: Tegaderm™(Absorbant, 3M)<br>Transparent dressing allows for wound monitoring without changing the dressing Clear design takes the guesswork out of application over the wound Novel acrylic polymer pad technology designed to handle low to moderate wound drainage. No dressing breakdown in the wound. Low friction surface minimizes potential for friction and shear. Allows for gentle removal from skin. Barrier to external contaminants, body fluids, bacteria and viruses. | Other: Tegaderm™(Absorbant, 3M)<br>* 3M™ Tegaderm™ Dressing helps provide the natural moisture balance conducive to wound healing.<br>|
| Active Comparator: Xeroform™<br>Xeroform™ Occlusive Petrolatum Gauze. 3% Bismuth Tribromophenate in a special petrolatum blend on fine mesh gauze. Non-adherent. Clings and conforms to all body contours. | Other: Xeroform™<br>* Xeroform™ consists of a fine-mesh gauze impregnated with bismuth tribromophenate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Heal | Patient will be followed up during routine post-operative appointments at the clinic weekly to check the healing process of the donor site wound. | 7-21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aesthetic Outcome | During routine followup visits to the clinic, the donor site aesthetic outcome will be observed and recorded clinically and digitally (photographs). The Vancouver Scar Scale will be used. | 1-12 weeks | 
| Pain intensity measure | Self reported pain intensity in the morning and evening with activity over the past 7 days. Each item is scored on a scale of 0-10 (0= no pain, 10= highest intensity of pain) | 7 days |