PRP, Skin Graft (Allograft) Rejection, Skin Graft Complications, Skin Graft Detachment
Conditions
Brief summary
The purpose of this study is to compare post-operative skin graft donor site pain between those treated with standard wound care vs PRP. Secondarily the study is designed to compare time to complete donor site healing. The null hypothesis is that here is no difference in post-operative donor site pain between those treated with standard wound care and PRP. The secondary null hypothesis is that there is no difference in time to donor site healing.
Detailed description
A well-known complaint after a split thickness skin graft surgery is pain at the graft donor site. In our patients, it has been have noticed those whose donor sites have been treated with platelet rich plasma (PRP) have endorsed decreased pain compared to those who have not. During our literature review few studies have looked at this issue. One such study by Miller et. al. looked at 5 patients whose donor site was treated with PRP showed a significant decrease in pain on a Likert visual pain scale. Kakudo et al. performed a side-by-side comparison on a single patient with half the wound treated with PRP and the other as a control. They found better epithelization and reduced pain during dressing changes for the treatment group. Both of these studies show promising results for pain reduction with PRP use, unfortunately there are no high quality randomized control trials that have looked at this. Another issue is many studies on PRP assess reduction of pain as a secondary outcome and instead focus on wound healing and epithelization primarily. This study hopes to elucidate the effect of PRP application on graft donor site pain. Patients will be recruited to the study and randomized into either treatment or control group based on medical necessity for a skin graft. This study will assess pain at the donor site via Likert pain scale and monitor narcotic pain medication use.
Interventions
PROCEDUREPRP harvest and preparation
The PRP harvest and preparation will be done in the operating room with the help of the hospital blood bank. The skin graft surgery will be completed by Dr. Jason Lowe and/or one of the Orthopaedic Surgery residents. Follow up will also be completed by Dr. Lowe or one of the residents. Data analysis will be done by Drs. Lowe and Manoharan. Each patient that will be undergoing a skin graft surgery will be randomized into either the PRP (intervention) group or the control group. Follow up and dressing changes will be the same for both groups. Each group will be prescribed a multi-modal pain regimen to reduce narcotic usage.
Sponsors
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Each patient that will be undergoing a skin graft surgery will be randomized into either the PRP (intervention) group or the control group. Follow up and dressing changes will be the same for both groups. Each group will be prescribed a multi-modal pain regimen to reduce narcotic usage.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Any patient requiring a split thickness skin graft and is above the age of 18.
Exclusion criteria
* Medical history of chronic pain at the donor site * Inability to follow up * Unable to participate in pre or post operative questionnaire inclusive of organic * Traumatic, chemical or degenerative causes of altered mental sensorium * Age \<18.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient post-operative donor site pain. | Through study completion, an average of 1 year | Donor site pain according to the visual analog scale score. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain and worst pain. |
| Duration of donor site wound | Through study completion, an average of 1 year | Duration of wound care after surgery |
| Opioid consumption | Through study completion, an average of 1 year | Opioid consumption after surgery |
Countries
United States
Outcome results
None listed