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

Not Applicable

Completed

• Conditions: Head and Neck Disorder; Free Flap
• Interventions: Procedure: Platelet Rich Fibrin (PRF) Application

• Registration Number: NCT04023474
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-07-12
• Study First Submitted QC: 2019-07-16
• Study First Posted: 2019-07-17
• Study Start: 2019-12-16
• Status Verified: 2020-09
• Primary Completion: 2020-09-10
• Study Completion: 2020-09-10
• Last Update Submitted: 2020-09-29
• Last Update Posted: 2020-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platelet Rich Fibrin (PRF) Group	Platelet Rich Fibrin (PRF) Application	Patients randomized to this group will receive treatment with a PRF graft in clinic at the time any pertinent post-operative complication is identified.

Primary Outcome Measures

Name	Time	Method
Change in healing time at 3 months post-operative	Up to 3 months	Improved healing of PRF patients compared to control group.

Trial Locations

Locations (1)

UF Health Jacksonville; 🇺🇸 Jacksonville, Florida, United States