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OpenTrials
Completed

NCT Number: NCT04023474

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

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.

Completed

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Key information

Conditions

Head and Neck Disorder Free Flap

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF Health Jacksonville

Jacksonville, Florida, 32209, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Platelet Rich Fibrin (PRF) Application

Procedure

Platelet Rich Fibrin application to flap defect.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 17, 2019
Registry last updated
Sep 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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