Platelet-Rich Fibrin in the Healing of Regional and Free... | NCT04023474

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

NCT04023474

Sponsor

University of Florida

Status

Completed

Last Update Posted

Sep 30, 2020Actual

Enrollment

3Actual

Phase

Not Applicable

Conditions

Head and Neck Disorder
Free Flap

Interventions

Platelet Rich Fibrin (PRF) Application

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 16, 2019Actual

Primary Completion Date

Sep 10, 2020Actual

Completion Date

Sep 10, 2020Actual

First Submitted Date

Jul 12, 2019

First Submission Date that Met QC Criteria

Jul 16, 2019

First Posted Date

Jul 17, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2020

Last Update Posted Date

Sep 30, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Platelet Rich Fibrin (PRF) Application	Procedure	Platelet Rich Fibrin application to flap defect.	Platelet Rich Fibrin (PRF) Group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Salam Salman, MD, DDS	University of Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UF Health Jacksonville		Jacksonville	Florida	32209	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

IPD will not be shared with other researchers.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D056690	Prolactin-Releasing Hormone

Ancestor Terms

ID	Term
D007028	Hypothalamic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

Browse Leaves

Not provided

Browse Branches

Not provided