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Platelet-Rich Fibrin in the Healing of Regional and Free Flaps

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ClinicalTrials.gov Identifier: NCT04023474
Recruitment Status : Not yet recruiting
First Posted : July 17, 2019
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief 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.

Condition or disease Intervention/treatment Phase
Head and Neck Disorder Free Flap Procedure: Platelet Rich Fibrin (PRF) Application Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : August 15, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: Platelet Rich Fibrin (PRF) Group
Patients randomized to this group will receive treatment with a PRF graft in clinic at the time any pertinent post-operative complication is identified.
Procedure: Platelet Rich Fibrin (PRF) Application
Platelet Rich Fibrin application to flap defect.

No Intervention: No Platelet Rich Fibrin Group
Participants in the observational control group will be managed at the time of the complication by standard of care methods.



Primary Outcome Measures :
  1. Change in healing time at 3 months post-operative [ Time Frame: Up to 3 months ]
    Improved healing of PRF patients compared to control group.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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): NCT04023474


Contacts
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Contact: Salam Salman, MD, DDS 904-244-3901 salam.salman@jax.ufl.edu
Contact: Stacy Smith 904-244-3884 stacy.smith@jax.ufl.edu

Locations
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United States, Florida
UF Health Jacksonville
Jacksonville, Florida, United States, 32209
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Salam Salman, MD, DDS University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04023474     History of Changes
Other Study ID Numbers: IRB201901618
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers.

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

Keywords provided by University of Florida:
Platelet-Rich Fibrin (PRF)