Skin Graft Complications
Conditions
Brief summary
The investigators objective is to compare OASIS wound matrix with other commonly used dressings available for the donor site in split thickness skin grafting in order to determine which dressing provides the best outcome based on pain level, time to healing and aesthetic outcome.
Detailed description
Investigators seek to compare Oasis wound matrix with Tegaderm and Xeroform in order to determine whether advantages exist in one or more of the dressing types that are approved and currently used for split-thickness skin graft donor site dressings. Patients will be randomly assigned to one of the three treatment groups and followed up post-operatively and treated as per current standard of care. Data to be collected and analyzed includes: patient age, co-morbid illnesses, medication, skin-graft donor location, skin-graft donor area, STSG thickness, infection rate, complications involving the donor site, post-operative pain score every morning until hospital discharge, healing rate, photographs of the donor site immediately post-operatively and then at routine follow-up appointments.
Interventions
OTHERTegaderm™(Absorbant, 3M)
3M™ Tegaderm™ Dressing helps provide the natural moisture balance conducive to wound healing.
DEVICEOASIS® wound matrix
OASIS® Matrix is indicated for the management of wounds including: partial- and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), draining wounds, surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence).
OTHERXeroform™
Xeroform™ consists of a fine-mesh gauze impregnated with bismuth tribromophenate.
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* patients scheduled to undergo split thickness skin grafting * patients able to consent without a proxy
Exclusion criteria
* confounding medical conditions * previous skin grafting from site * prior use of biological skin substitute on site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Heal | 7-21 days | Patient will be followed up during routine post-operative appointments at the clinic weekly to check the healing process of the donor site wound. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aesthetic Outcome | 1-12 weeks | During routine followup visits to the clinic, the donor site aesthetic outcome will be observed and recorded clinically and digitally (photographs). The Vancouver Scar Scale will be used. |
| Pain intensity measure | 7 days | Self reported pain intensity in the morning and evening with activity over the past 7 days. Each item is scored on a scale of 0-10 (0= no pain, 10= highest intensity of pain) |
Outcome results
None listed