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

NCT04023474 | Completed

• 1 other identifier: IRB201901618
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Disorder; Free Flap

Keywords

Platelet-Rich Fibrin (PRF)

Outcome Measures

Primary Outcomes (1)

• Change in healing time at 3 months post-operative

  Improved healing of PRF patients compared to control group.

  Up to 3 months

Study Arms (2)

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.

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.

Interventions

Platelet Rich Fibrin (PRF) Application PROCEDURE

Platelet Rich Fibrin application to flap defect.

Platelet Rich Fibrin (PRF) Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health Jacksonville

Jacksonville, Florida, 32209, United States

Location

MeSH Terms

Interventions

Prolactin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Salam Salman, MD, DDS

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 17, 2019
• Study Start: December 16, 2019
• Primary Completion: September 10, 2020
• Study Completion: September 10, 2020
• Last Updated: September 30, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)