The Effect of Platelet Rich Plasma on Pain at Skin Graft Donor Sites
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|ClinicalTrials.gov Identifier: NCT03937765|
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : March 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Skin Graft (Allograft) Rejection Skin Graft Complications Skin Graft Detachment PRP||Procedure: PRP harvest and preparation||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Platelet Rich Plasma on Pain at Skin Graft Donor Sites|
|Actual Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||July 1, 2020|
|Estimated Study Completion Date :||October 1, 2020|
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.
Procedure: PRP 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.
No Intervention: 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937765
|Contact: Aditya Manoharan, MDfirstname.lastname@example.org|
|Contact: Jacob Sorenson, BSemail@example.com|
|United States, Arizona|
|University of Arizona College of Medicine||Recruiting|
|Tucson, Arizona, United States, 85721|
|Contact: Aditya Manoharan, MD 480-234-5607 firstname.lastname@example.org|
|Contact: Jacob Sorenson, BS 14802683411 email@example.com|
|Principal Investigator: Jason Lowe, MD|
|Principal Investigator: Aditya Manoharan, MD|
|Sub-Investigator: Jacob Sorenson, BS|
|Sub-Investigator: Cindy Fastje, BS|
|Principal Investigator:||Aditya Manoharan, MD||University of Arizona College of Medicine Department of Orthopaedic Surgery|
|Principal Investigator:||Jason Lowe, MD||University of Arizona College of Medicine Department of Orthopaedic Surgery|