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

Knee Disease Clinical Trial

— Fibrin4Fast  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04165863
• Other study ID #: Fibrin4Fast
• Status: Completed
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: November 4, 2021

Study information

• Verified date: November 2019
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 4, 2021
• Est. primary completion date: November 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Knee Disease

Intervention

Procedure:
• total knee replacement surgery
total knee replacement surgery

Locations

Country	Name	City	State
Italy	IRCCS Itituto Ortopedico Rizzoli	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Galat DD, McGovern SC, Larson DR, Harrington JR, Hanssen AD, Clarke HD. Surgical treatment of early wound complications following primary total knee arthroplasty. J Bone Joint Surg Am. 2009 Jan;91(1):48-54. doi: 10.2106/JBJS.G.01371. — View Citation

Harato K, Tanikawa H, Morishige Y, Kaneda K, Niki Y. What are the important surgical factors affecting the wound healing after primary total knee arthroplasty? J Orthop Surg Res. 2016 Jan 13;11:7. doi: 10.1186/s13018-016-0340-y. — View Citation

Rui M, Zheng X, Sun SS, Li CY, Zhang XC, Guo KJ, Zhao FC, Pang Y. A prospective randomised comparison of 2 skin closure techniques in primary total hip arthroplasty surgery. Hip Int. 2018 Jan;28(1):101-105. doi: 10.5301/hipint.5000534. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical improvement of the healing process	Clinical improvement of the healing process, assessed by application of the Hollander Wound Evaluation Scales at 2 weeks of follow up	2 weeks
Secondary	Dermatology life quality	Dermatology life quality index improvement at 3 days, 15 days and 1 month	3 days, 15 days and 1 month