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

Loma Linda University (LLU)

Status and phase: Withdrawn; Phase 4

Conditions: Skin Graft Complications

Treatments: Device: OASIS® wound matrix; Other: Tegaderm™(Absorbant, 3M); Other: Xeroform™

Study type: Interventional

Funder types: Other

Identifiers

NCT02994589

5150267

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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0 participants in 3 patient groups

OASIS® wound matrix

Experimental group

Description:

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.

Treatment:

Device: OASIS® wound matrix

Tegaderm™(Absorbant, 3M)

Active Comparator group

Description:

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.

Treatment:

Other: Tegaderm™(Absorbant, 3M)

Xeroform™

Active Comparator group

Description:

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.

Treatment:

Other: Xeroform™