Clinical trial NCT03937765: The Effect of Platelet Rich Plasma on Pain at Skin Graft Donor Sites
Official title: The Effect of Platelet Rich Plasma on Pain at Skin Graft Donor Sites
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Skin Graft (Allograft) Rejection
Skin Graft Complications
Skin Graft Detachment
PRP
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Patient post-operative donor site pain.
timeFrame: Through study completion, an average of 1 year
measure: Duration of donor site wound
timeFrame: Through study completion, an average of 1 year
measure: Opioid consumption
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona College of Medicine
state: Arizona
Study officials:
affiliation: University of Arizona College of Medicine Department of Orthopaedic Surgery
name: Aditya Manoharan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona College of Medicine Department of Orthopaedic Surgery
name: Jason Lowe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.