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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03937765
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
University of Arizona

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.

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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, 2020
Estimated Study Completion Date : October 1, 2020

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.



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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937765


Contacts
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Contact: Aditya Manoharan, MD 14802345607 amanoharan@ortho.arizona.edu
Contact: Jacob Sorenson, BS 14802683411 jcsorenson20@gmail.com

Locations
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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
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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
Publications of Results:
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Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT03937765    
Other Study ID Numbers: PRP Study
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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