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

Phase 4

Withdrawn

• Conditions: Skin Graft Complications
• Interventions: Other: Xeroform™; Device: OASIS® wound matrix; Other: Tegaderm™(Absorbant, 3M)

• Registration Number: NCT02994589
• Lead Sponsor: Loma Linda University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-08-31
• Study Start: 2016-10
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Study First Submitted QC: 2016-12-13
• Last Update Submitted: 2016-12-13
• Study First Posted: 2016-12-16
• Last Update Posted: 2016-12-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Xeroform™	Xeroform™	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.
OASIS® wound matrix	OASIS® wound matrix	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.
Tegaderm™(Absorbant, 3M)	Tegaderm™(Absorbant, 3M)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Aesthetic Outcome	1-12 weeks	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.
Pain intensity measure	7 days	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)