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

December 13, 2016 updated by: Loma Linda University

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: OASIS® wound matrix
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).
Active Comparator: 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.
Other: Tegaderm™(Absorbant, 3M)
3M™ Tegaderm™ Dressing helps provide the natural moisture balance conducive to wound healing.
Active Comparator: 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.
Other: Xeroform™
Xeroform™ consists of a fine-mesh gauze impregnated with bismuth tribromophenate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Heal
Time Frame: 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.
7-21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aesthetic Outcome
Time Frame: 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.
1-12 weeks
Pain intensity measure
Time Frame: 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)
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

  • Study Chair: Subhas Gupta, MD, PhD, Loma Linda University
  • Principal Investigator: Hahns Kim, MD, Loma Linda University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

August 31, 2015

First Submitted That Met QC Criteria

December 13, 2016

First Posted (Estimate)

December 16, 2016

Study Record Updates

Last Update Posted (Estimate)

December 16, 2016

Last Update Submitted That Met QC Criteria

December 13, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 5150267

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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