The Effect of Platelet Rich Plasma on Pain at Skin Graft Donor Sites

• ClinicalTrials.gov Identifier: NCT03937765
• Recruitment Status: Recruiting
• First Posted: May 6, 2019
• Last Update Posted: November 4, 2020
• Sponsor: University of Arizona
• Information provided by (Responsible Party): University of Arizona

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Skin Graft (Allograft) Rejection; Skin Graft Complications; Skin Graft Detachment; PRP	Procedure: PRP harvest and preparation	Not Applicable

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 (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• 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)
• Primary Purpose: Treatment
• 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, 2021
• Estimated Study Completion Date: October 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	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.

Outcome Measures

Primary Outcome Measures :

1. 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."
2. Duration of donor site wound [ Time Frame: Through study completion, an average of 1 year ]
   Duration of wound care after surgery
3. Opioid consumption [ Time Frame: Through study completion, an average of 1 year ]
   Opioid consumption after surgery

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Contacts

Contact: Aditya Manoharan, MD; 14802345607; amanoharan@ortho.arizona.edu

Contact: Jacob Sorenson, BS; 14802683411; jcsorenson20@gmail.com

Locations

United States, Arizona

University of Arizona College of Medicine; Recruiting

Tucson, Arizona, United States, 85721

Contact: Aditya Manoharan, MD 480-234-5607 amanoharan@ortho.arizona.edu

Contact: Jacob Sorenson, BS 14802683411 jcsorenson20@gmail.com

Principal Investigator: Jason Lowe, MD

Principal Investigator: Aditya Manoharan, MD

Sub-Investigator: Jacob Sorenson, BS

Sub-Investigator: Cindy Fastje, BS

Sponsors and Collaborators

University of Arizona

Investigators

• 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

More Information

Publications of Results:

Miller JD, Rankin TM, Hua NT, Ontiveros T, Giovinco NA, Mills JL, Armstrong DG. Reduction of pain via platelet-rich plasma in split-thickness skin graft donor sites: a series of matched pairs. Diabet Foot Ankle. 2015 Jan 22;6:24972. doi: 10.3402/dfa.v6.24972. eCollection 2015.

Kakudo N, Kushida S, Minakata T, Suzuki K, Kusumoto K. Platelet-rich plasma promotes epithelialization and angiogenesis in a splitthickness skin graft donor site. Med Mol Morphol. 2011 Dec;44(4):233-6. doi: 10.1007/s00795-010-0532-1. Epub 2011 Dec 17.

Carter MJ, Fylling CP, Parnell LK. Use of platelet rich plasma gel on wound healing: a systematic review and meta-analysis. Eplasty. 2011;11:e38. Epub 2011 Sep 15.

Boonstra AM, Schiphorst Preuper HR, Reneman MF, Posthumus JB, Stewart RE. Reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain. Int J Rehabil Res. 2008 Jun;31(2):165-9. doi: 10.1097/MRR.0b013e3282fc0f93.

Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.

• Responsible Party: University of Arizona
• ClinicalTrials.gov Identifier: NCT03937765
• Other Study ID Numbers: PRP Study
• First Posted: May 6, 2019
• Last Update Posted: November 4, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No