Burns
Conditions
Keywords
Skin graft
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.
Interventions
We will place an amniotic membrane dressing on the donor site
OTHERGentamicin and xeroform dressing
We will place xeroform, gentamicin and telfa on the donor site
Sponsors
Emory University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* undergoing a split thickness skin graft procedure with two or more donor sites
Exclusion criteria
* less than 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of scarring between donor sites | Postoperative day 5 | Scarring on postoperative day 5 will be evaluated by burn unit surgeons |
| Change in postoperative pain | Postoperative days 1, 2 and 5 | Participants will report their pain level for each donor site as a numeric score from 1 to 10. |
| Change in re-epithelialization | Postoperative days 2 and 5 | The percent of re-epithelialization for each donor site will be evaluated by burn unit surgeons on postoperative days 2 and 5. |
| Comparison of hypopigmentation between donor sites | Postoperative day 5 | Hypopigmentation on postoperative day 5 will be evaluated by burn unit surgeons. |
Countries
United States
Outcome results
None listed