Amniotic Membrane for Donor Site Healing
| Status: | Completed |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/23/2018 |
| Start Date: | February 1, 2017 |
| End Date: | August 31, 2017 |
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.
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.
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.
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.
Inclusion Criteria:
- undergoing a split thickness skin graft procedure with two or more donor sites
Exclusion Criteria:
- less than 18 years of age
We found this trial at
1
site
Click here to add this to my saved trials
