Elective Foot and Ankle Surgery.PRPNCT01639144
Use of Platelet-Rich Plasma (PRP) and Platelet-Poor Plasma (PPP) to Prevent Infection and Delayed Wound Healing
A study testing PRP and PPP in people with Elective Foot and Ankle Surgery., run by Gary M. Kiebzak, Ph.D. at 1 site in United States.
Trial summary
The purpose of this study is to see if applying PRP and PPP to surgical sites and the closing incision helps prevent infection and slow wound healing. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Elective Foot and Ankle Surgery.
- What is being tested?
- PRP and PPP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 515 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective foot and ankle surgery.
Who cannot join
- Younger than 18 years, older than 80 years of age.
Trial locations and contacts
1 site in 1 country.
United States1 site
UHZ Sports Medicine Institute
Coral Gables, Florida, 33146
About this study
Official title: Use of Platelet-Rich Plasma (PRP) and Platelet-Poor Plasma (PPP) to Prevent Infection and Delayed Wound Healing After Elective Foot and Ankle Surgery in Healthy Adults
The purpose of this study is to see if applying PRP and PPP to surgical sites and the closing incision helps prevent infection and slow wound healing.
Read the detailed description
This will be a prospective, randomized study with patients blinded to either receiving platelet-rich plasma (PRP) and platelet-poor plasma (PPP) treatment or no treatment. We hypothesize that the antimicrobial properties of PRP and barrier properties of PPP (acting like a tissue sealant) will serve to inhibit deep incisional surgical site infection and help prevent delayed wound healing within 60 days of surgery. Thus, the incidence of infection and delayed wound healing will be lower in patients receiving PRP and PPP compared to patients who do not receive PRP and PPP. However, due to clinical equipoise, we do not know for certain that PRP and PPP is truly effective. The cost of preparing PRP and PPP is substantial, and involves a blood draw that would not otherwise be done. Thus, it is important to know if this treatment is effective or not.
- Conditions
- Elective Foot and Ankle Surgery.
- Being tested
- PRP and PPP
- Keywords
- Infection, delayed wound healing, platelet-rich plasma
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP and PPPBiological
Autogenous PRP and PPP
| Study group | Role | What they receive |
|---|---|---|
| Receiving PRP and PPP. | Active comparator | Administration of PRP and PPP to surgical site. Receives: Biological: PRP and PPP |
| Control | No intervention | Group not receiving autogenous PRP and PPP. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Infection and Delayed Wound Healing.
Postoperative deep incisional surgical site infection and delayed wound healing (lack of primary healing of skin edges typically with wound secretion).
Measured: Infection: 30 days after surgery. Delayed wound healing: 60 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Elective Foot and Ankle Surgery.Studies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 515 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gary M. Kiebzak, Ph.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gary M. Kiebzak, Ph.D., UHZ Sports Medicine Institute
- Investigators
- Gary M Kiebzak, Ph.D., Study director, Center for Research & Grants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639144
- Sponsor's protocol ID
- 12-024
- Acronym
- PRP
- Status last verified
- May 2015
- First submitted
- 10 Jul 2012
- Last updated
- 22 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Platelet-Rich Plasma (PRP) and Platelet-Poor Plasma (PPP) to Prevent Infection and Delayed Wound Healing After Elective Foot and Ankle Surgery in Healthy Adults
- ClinicalTrials.gov ID
- NCT01639144
- Acronym / sponsor ID
- PRP / 12-024
- Conditions
- Elective Foot and Ankle Surgery.
- Keywords
- Infection, delayed wound healing, platelet-rich plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 515 participants (actual)
- Lead sponsor
- Gary M. Kiebzak, Ph.D.University, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 12 Jul 2012 (estimated)
- Results
- Posted 22 May 2015
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 see if applying PRP and PPP to surgical sites and the closing incision helps prevent infection and slow wound healing.
Detailed description
This will be a prospective, randomized study with patients blinded to either receiving platelet-rich plasma (PRP) and platelet-poor plasma (PPP) treatment or no treatment. We hypothesize that the antimicrobial properties of PRP and barrier properties of PPP (acting like a tissue sealant) will serve to inhibit deep incisional surgical site infection and help prevent delayed wound healing within 60 days of surgery. Thus, the incidence of infection and delayed wound healing will be lower in patients receiving PRP and PPP compared to patients who do not receive PRP and PPP. However, due to clinical equipoise, we do not know for certain that PRP and PPP is truly effective. The cost of preparing PRP and PPP is substantial, and involves a blood draw that would not otherwise be done. Thus, it is important to know if this treatment is effective or not.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receiving PRP and PPP. | Active comparator | Biological: PRP and PPPAdministration of PRP and PPP to surgical site. |
| Control | No intervention | –Group not receiving autogenous PRP and PPP. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective foot and ankle surgery.
Key exclusion criteria (1 listed)
- Younger than 18 years, older than 80 years of age.
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 and PPPAutogenous PRP and PPP | Biological | Receiving PRP and PPP. |
Primary outcome
Postoperative Infection and Delayed Wound Healing.
Time frame: Infection: 30 days after surgery. Delayed wound healing: 60 days.
Postoperative deep incisional surgical site infection and delayed wound healing (lack of primary healing of skin edges typically with wound secretion).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Elective Foot and Ankle Surgery.
RecruitingPhase 4
Skin Preparation for Elective Foot and Ankle Surgery
Microbial Colonization, Foot and Ankle Disorders
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.
Gary M Kiebzak, Ph.D. study director
Center for Research & Grants
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 and PPP in people with Elective Foot and Ankle Surgery., run by Gary M. Kiebzak, Ph.D. 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 1 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: finished, as of the sponsor's last update on 22 May 2015. 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?
Yes. Results are posted in the registry (first posted 22 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Postoperative Infection and Delayed Wound Healing. (time frame: Infection: 30 days after surgery. Delayed wound healing: 60 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2015.