Skin Graft (Allograft) RejectionNCT03937765
The Effect of Platelet Rich Plasma on Pain at Skin Graft Donor Sites
A study testing PRP harvest and preparation in people with Skin Graft (Allograft) Rejection and Skin Graft Complications, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Graft (Allograft) Rejection, Skin Graft Complications, Skin Graft Detachment
- What is being tested?
- PRP harvest and preparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any patient requiring a split thickness skin graft and is above the age of 18.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona College of Medicine
Tucson, Arizona, 85721
About this study
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.
Read the 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.
- Being tested
- PRP harvest and preparation
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP harvest and preparationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: Through study completion, an average of 1 year
Duration of donor site wound
Duration of wound care after surgery
Measured: Through study completion, an average of 1 year
Opioid consumption
Opioid consumption after surgery
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start1 Nov 2019
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Why it stopped: Suspended per IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Skin Graft (Allograft) RejectionStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aditya Manoharan, MD, Principal investigator, University of Arizona College of Medicine Department of Orthopaedic SurgeryJason Lowe, MD, Principal investigator, University of Arizona College of Medicine Department of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937765
- Sponsor's protocol ID
- PRP Study
- Status last verified
- Mar 2024
- First submitted
- 29 Apr 2019
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25623477Kakudo 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.
PubMed 22179187Carter 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.
PubMed 22028946Boonstra 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.
PubMed 18467932Delgado 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.
PubMed 30211382
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Platelet Rich Plasma on Pain at Skin Graft Donor Sites
- ClinicalTrials.gov ID
- NCT03937765
- Acronym / sponsor ID
- PRP Study
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Suspended per IRB
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| PRP | Experimental | Procedure: PRP harvest and preparationIntervention 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient requiring a split thickness skin graft and is above the age of 18.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRP harvest and preparationThe 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. | Procedure or surgery | PRP |
Primary outcome
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."
Duration of donor site wound
Time frame: Through study completion, an average of 1 year
Duration of wound care after surgery
Opioid consumption
Time frame: Through study completion, an average of 1 year
Opioid consumption after surgery
Results and safety
The study was stopped early (reason given: Suspended per IRB). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Results publication: PubMed 25623477Miller 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.
- Results publication: PubMed 22179187Kakudo 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.
- Results publication: PubMed 22028946Carter 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.
- Results publication: PubMed 18467932Boonstra 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.
- Results publication: PubMed 30211382Delgado 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aditya Manoharan, MD principal investigator
University of Arizona College of Medicine Department of Orthopaedic Surgery
Jason Lowe, MD principal investigator
University of Arizona College of Medicine Department of Orthopaedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP harvest and preparation in people with Skin Graft (Allograft) Rejection and Skin Graft Complications, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Suspended per IRB). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient post-operative donor site pain. (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03937765, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.