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

NCT03937765 | Terminated

• 1 other identifier: PRP Study
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Graft (Allograft) Rejection; Skin Graft Complications; Skin Graft Detachment; PRP

Outcome Measures

Primary Outcomes (3)

• Patient post-operative donor site pain.

  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."

  Through study completion, an average of 1 year

• Duration of donor site wound

  Duration of wound care after surgery

  Through study completion, an average of 1 year

• Opioid consumption

  Opioid consumption after surgery

  Through study completion, an average of 1 year

Study Arms (2)

PRP

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

PRP harvest and preparation PROCEDURE

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.

PRP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient requiring a split thickness skin graft and is above the age of 18.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona College of Medicine

Tucson, Arizona, 85721, United States

Location

Related Publications (5)

• 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.

  PMID: 25623477 RESULT

• 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.

  PMID: 22179187 RESULT

• 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.

  PMID: 22028946 RESULT

• 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.

  PMID: 18467932 RESULT

• 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.

  PMID: 30211382 RESULT

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 6, 2019
• Study Start: November 1, 2019
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)