Head and Neck DisorderNCT04023474
Platelet-Rich Fibrin in the Healing of Regional and Free Flaps
A study testing Platelet Rich Fibrin (PRF) Application in people with Head and Neck Disorder and Free Flap, run by University of Florida at 1 site in United States.
Trial summary
Determine if the use of platelet-rich fibrin (PRF) versus historical treatment methods improves the post-operative management of healing complications from flap donor sites. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Disorder, Free Flap
- What is being tested?
- Platelet Rich Fibrin (PRF) Application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2019to 10 Sep 2020
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who had surgery involving a microvascular free flap or a myocutaneous regional flap for head and neck reconstruction who develop one of the following donor site complications: wound dehiscence, wound margin breakdown or contraction resulting in healing by secondary intention, myocutaneous fistula formation, or incomplete coverage of the donor site by a skin graft placed in the operating room.
Who cannot join
- Patients under 18 years of age
- Patient's unable to participate in blood draw either due to medical compromise, inability to tolerate the procedure, or inability of the physician to successfully draw the blood at the time of appointment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Platelet-Rich Fibrin in the Healing of Regional and Free Flap Donor Sites for Head and Neck Surgery Patients: A Prospective Randomized Clinical Trial
Determine if the use of platelet-rich fibrin (PRF) versus historical treatment methods improves the post-operative management of healing complications from flap donor sites.
- Conditions
- Head and Neck Disorder, Free Flap
- Being tested
- Platelet Rich Fibrin (PRF) Application
- Keywords
- Platelet-Rich Fibrin (PRF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich Fibrin (PRF) ApplicationProcedure or surgery
Platelet Rich Fibrin application to flap defect.
| Study group | Role | What they receive |
|---|---|---|
| Platelet Rich Fibrin (PRF) Group | Experimental | Patients randomized to this group will receive treatment with a PRF graft in clinic at the time any pertinent post-operative complication is identified. Receives: Procedure: Platelet Rich Fibrin (PRF) Application |
| No Platelet Rich Fibrin Group | No intervention | Participants in the observational control group will be managed at the time of the complication by standard of care methods. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in healing time at 3 months post-operative
Improved healing of PRF patients compared to control group.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start16 Dec 2019
- Primary completion10 Sep 2020
- Study completion10 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck DisorderStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Salam Salman, MD, DDS, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023474
- Sponsor's protocol ID
- IRB201901618
- Status last verified
- Sep 2020
- First submitted
- 12 Jul 2019
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Platelet-Rich Fibrin in the Healing of Regional and Free Flap Donor Sites for Head and Neck Surgery Patients: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04023474
- Acronym / sponsor ID
- IRB201901618
- Conditions
- Head and Neck Disorder, Free Flap
- Keywords
- Platelet-Rich Fibrin (PRF)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 17 Jul 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.
Determine if the use of platelet-rich fibrin (PRF) versus historical treatment methods improves the post-operative management of healing complications from flap donor sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet Rich Fibrin (PRF) Group | Experimental | Procedure: Platelet Rich Fibrin (PRF) ApplicationPatients randomized to this group will receive treatment with a PRF graft in clinic at the time any pertinent post-operative complication is identified. |
| No Platelet Rich Fibrin Group | No intervention | –Participants in the observational control group will be managed at the time of the complication by standard of care methods. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who had surgery involving a microvascular free flap or a myocutaneous regional flap for head and neck reconstruction who develop one of the following donor site complications: wound dehiscence, wound margin breakdown or contraction resulting in healing by secondary intention, myocutaneous fistula formation, or incomplete coverage of the donor site by a skin graft placed in the operating room.
Key exclusion criteria (2 listed)
- Patients under 18 years of age
- Patient's unable to participate in blood draw either due to medical compromise, inability to tolerate the procedure, or inability of the physician to successfully draw the blood at the time of appointment.
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 |
|---|---|---|
| Platelet Rich Fibrin (PRF) ApplicationPlatelet Rich Fibrin application to flap defect. | Procedure or surgery | Platelet Rich Fibrin (PRF) Group |
Primary outcome
Change in healing time at 3 months post-operative
Time frame: Up to 3 months
Improved healing of PRF patients compared to control group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
Related trials for Head and Neck Disorder
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Hypocalcemia, Hypoparathyroidism
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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.
Salam Salman, MD, DDS principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Rich Fibrin (PRF) Application in people with Head and Neck Disorder and Free Flap, run by University of Florida 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 2 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 30 Sep 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in healing time at 3 months post-operative (time frame: Up to 3 months). 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 30 Sep 2020.