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OpenTrials
Completed

NCT Number: NCT04165863

Effectiveness of Treatment With Rich Platelet Fibrin (PRF) VS Gold Standard 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.

Completed

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Key information

Conditions

Knee Disease

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Itituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

Who can participate

Healthy volunteers accepted: No

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

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;

Treatment and study plan

Total knee replacement surgery

Procedure

total knee replacement surgery

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Acronym: Fibrin4Fast

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 18, 2019
Registry last updated
Jan 19, 2022

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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