Amniotic Membrane for Donor Site Healing

NCT ID: NCT02947737

Last Updated: 2018-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2017-08-31

Brief Summary

The purpose of this study is to compare the effectiveness of applying amniotic membrane dressings compared to gentamicin and xeroform dressings to donor sites for skin grafts. This study will enroll ten participants who undergoing a split thickness skin graft procedure with two or more donor sites. The amniotic membrane will be applied to one donor site and a dressing of xeroform and gentamicin will be applied to another other donor site. Each participant will receive both types of dressing and will serve as their own control. Postoperative follow up will follow standard of care, regardless of the dressing type. Dressings will be removed on postoperative day 4 and participants will return to be re-examined one week after being discharged from the hospital.

Detailed Description

The use of amniotic membrane in the treatment of wounds has been employed for almost 100 years, with reports of it being used in skin grafting for burns and ulcers in 1913. This study will investigate the use of amniotic membrane as a donor site dressing (the area where skin is removed to be transplanted to the recipient site). Donor sites are often a significant cause of postoperative pain for patients who have undergone skin grafts. Furthermore, donor sites that fail to re-epithelialize or scar may require additional excision and skin grafting on the donor site itself. There is a paucity of literature in the United States regarding the use of amniotic membrane as a donor site dressing, however, studies from other countries have demonstrated an increase in patient comfort and a faster time to re-epithelialization. Inherent to amniotic membrane that makes it an ideal dressing include the presence of extracellular matrix components create integrity, epithelial cells participate in the healing process, and defensins confer antibacterial properties. MiMedx produces AmnioFix® which is a dehydrated preserved amniotic membrane that will be used in the dressing of our donor sites in contrast to gentamicin and xeroform based dressings. This study will see if patients have improved cosmetic outcomes, less postoperative pain and a faster time to re-epithelialization at the donor site treated with amniotic membrane compared to the standard of care.

Conditions

Burns

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Amniotic membrane dressing

One donor site per study participant will be covered with an amniotic membrane dressing.

Group Type: EXPERIMENTAL

Amniotic membrane dressing

Intervention Type: OTHER

We will place an amniotic membrane dressing on the donor site

Gentamicin and xeroform dressing

One donor site per study participant will be covered with a gentamicin and xeroform dressing.

Group Type: ACTIVE_COMPARATOR

Gentamicin and xeroform dressing

Intervention Type: OTHER

We will place xeroform, gentamicin and telfa on the donor site

Interventions

Amniotic membrane dressing

We will place an amniotic membrane dressing on the donor site

Intervention Type: OTHER

Gentamicin and xeroform dressing

We will place xeroform, gentamicin and telfa on the donor site

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• undergoing a split thickness skin graft procedure with two or more donor sites

Exclusion Criteria

• less than 18 years of age

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Rachael Williams

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rachael Williams, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Grady Health System

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00088758

Identifier Type: -

Identifier Source: org_study_id