Amniotic Membrane for Donor Site Healing

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02947737
• Other study ID #: IRB00088758
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: August 31, 2017

Study information

• Verified date: May 2018
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• less than 18 years of age

Related Conditions & MeSH terms

• Burns

Intervention

Other:
• Amniotic membrane dressing
We will place an amniotic membrane dressing on the donor site
• Gentamicin and xeroform dressing
We will place xeroform, gentamicin and telfa on the donor site

Locations

Country	Name	City	State
United States	Grady Health System	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Comparison of scarring between donor sites	Scarring on postoperative day 5 will be evaluated by burn unit surgeons	Postoperative day 5
Primary	Comparison of hypopigmentation between donor sites	Hypopigmentation on postoperative day 5 will be evaluated by burn unit surgeons.	Postoperative day 5