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

NCT ID: NCT04023474

Last Updated: 2020-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-16

Study Completion Date

2020-09-10

Brief Summary

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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

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Conditions

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Head and Neck Disorder Free Flap

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Platelet Rich Fibrin (PRF) Application

Intervention Type PROCEDURE

Platelet Rich Fibrin application to flap defect.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Platelet Rich Fibrin (PRF) Application

Platelet Rich Fibrin application to flap defect.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Salam Salman, MD, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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UF Health Jacksonville

Jacksonville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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IRB201901618

Identifier Type: -

Identifier Source: org_study_id

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