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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/23/2021.

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 March 25, 2020

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:Skin Graft Detachment
    Skin Graft (Allograft) Rejection
    Skin Graft Complications
    PRP
  • Intervention/Treatment: Procedure: PRP harvest and preparation
  • Phase: N/A
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
  • 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 2019
  • Estimated Primary Completion Date: July 2020
  • Estimated Study Completion Date: October 2020
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.
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
Tucson

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