The Effect of Platelet Rich Plasma on Pain at Skin Graft Donor Sites
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Arizona
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Patient post-operative donor site pain.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
PRP
Intervention group will receive PRP instead of the standard of care for skin grafts. PRP Group-will remove surgical dressing post operative day 5. Donor site will be cleaned with soap and water daily and dressed with gauze daily until drainage stops.
Intervention: PRP harvest and preparation (Procedure)
Control
Control group receiving the standard of care for skin grafts. Control Group-will remove gauze dressing post operative day 2 but leave adeptic. Donor site will be cleaned daily with soap and water. Gauze applied daily as needed for drainage and will be stopped when drainage stops. The adeptic, which forms a biologic dressing, will be removed by the patient over time as it lifts from the wound.
Outcomes
Primary Outcomes
Patient post-operative donor site pain.
Time Frame: 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
Time Frame: Through study completion, an average of 1 year
Duration of wound care after surgery
Opioid consumption
Time Frame: Through study completion, an average of 1 year
Opioid consumption after surgery
Secondary Outcomes
No secondary outcomes reported