Amniotic Membrane for Donor Site Healing

Investigating the Effects of Amniotic Membrane on Donor Site Healing and Postoperative Pain

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.

Study Overview

• Status: Completed
• Conditions: Burns
• Intervention / Treatment: Other: Amniotic membrane dressing; Other: Gentamicin and xeroform dressing

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• less than 18 years of age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amniotic membrane dressing; One donor site per study participant will be covered with an amniotic membrane dressing.	Other: Amniotic membrane dressing; We will place an amniotic membrane dressing on the donor site
Active Comparator: Gentamicin and xeroform dressing; One donor site per study participant will be covered with a gentamicin and xeroform dressing.	Other: Gentamicin and xeroform dressing; We will place xeroform, gentamicin and telfa on the donor site

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in postoperative pain	Participants will report their pain level for each donor site as a numeric score from 1 to 10.	Postoperative days 1, 2 and 5
Change in re-epithelialization	The percent of re-epithelialization for each donor site will be evaluated by burn unit surgeons on postoperative days 2 and 5.	Postoperative days 2 and 5
Comparison of scarring between donor sites	Scarring on postoperative day 5 will be evaluated by burn unit surgeons	Postoperative day 5
Comparison of hypopigmentation between donor sites	Hypopigmentation on postoperative day 5 will be evaluated by burn unit surgeons.	Postoperative day 5

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Rachael Williams, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): August 31, 2017
• Study Completion (Actual): August 31, 2017

Study Registration Dates

• First Submitted: October 26, 2016
• First Submitted That Met QC Criteria: October 26, 2016
• First Posted (Estimate): October 28, 2016

Study Record Updates

• Last Update Posted (Actual): May 21, 2018
• Last Update Submitted That Met QC Criteria: May 18, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Skin graft
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Gentamicins
• Other Study ID Numbers: IRB00088758

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No