Clinical trial NCT02947737: Amniotic Membrane for Donor Site Healing
Official title: Investigating the Effects of Amniotic Membrane on Donor Site Healing and Postoperative Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Keywords: Skin graft
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2016-10-28
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in postoperative pain
timeFrame: Postoperative days 1, 2 and 5
measure: Change in re-epithelialization
timeFrame: Postoperative days 2 and 5
measure: Comparison of scarring between donor sites
timeFrame: Postoperative day 5
measure: Comparison of hypopigmentation between donor sites
timeFrame: Postoperative day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
Study officials:
affiliation: Emory University
name: Rachael Williams, MD
role: PRINCIPAL_INVESTIGATOR
References: