Effectiveness of Treatment With Rich Platelet Fibrin (PRF) VS Gold Standard in Patients Undergoing Knee Replacement (Fibrin4Fast)

January 18, 2022 updated by: Istituto Ortopedico Rizzoli

Effectiveness of Treatment With Rich Platelet Fibrin (PRF) VS Gold Standard in the Healing Process of Surgical Wounds in Patients Undergoing Knee Replacement

Randomized controlled single blind trial for the evaluation of the treatment of the surgical wound healing process with Platelet-Rich-Fibrin compared to the gold standard (without Platelet-Rich-Fibrin) in patients undergoing knee replacement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • BO
      • Bologna, BO, Italy, 40136
        • IRCCS Itituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males or females undergoing a total knee prosthesis.
  • Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions.
  • Hb > 11 g/dl; Platelet value > 150.000 plt/mmc;
  • Patients with non clinical alteration of ECG;
  • Signature of informed consent;

Exclusion Criteria:

  • Patients incapable of understanding and of wanting;
  • Systemic disorders such as diabetes, rheumatic diseases;
  • Patients with malignancy;
  • Thyroid metabolic disorders ;
  • Abuse of alcohol, drugs and pharmaceutical drugs
  • Body mass index > 40;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
treatment of the surgical wound healing process with Platelet-rich-fibrin in patients undergoing total knee replacement surgery
Procedure: total knee replacement surgery
total knee replacement surgery
Active Comparator: B
Gold standard treatment of the surgical wound healing process without Platelet-rich-fibrin in patients undergoing total knee replacement surgery
Procedure: total knee replacement surgery
total knee replacement surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical improvement of the healing process
Time Frame: 2 weeks
Clinical improvement of the healing process, assessed by application of the Hollander Wound Evaluation Scales at 2 weeks of follow up
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dermatology life quality
Time Frame: 3 days, 15 days and 1 month
Dermatology life quality index improvement at 3 days, 15 days and 1 month
3 days, 15 days and 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2020

Primary Completion (Actual)

November 4, 2021

Study Completion (Actual)

November 4, 2021

Study Registration Dates

First Submitted

November 14, 2019

First Submitted That Met QC Criteria

November 14, 2019

First Posted (Actual)

November 18, 2019

Study Record Updates

Last Update Posted (Actual)

January 19, 2022

Last Update Submitted That Met QC Criteria

January 18, 2022

Last Verified

November 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • Fibrin4Fast

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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