Standard Dressing Versus Moist Dressing in the Course of the Postoperative Wound in Patients With Knee Prosthesis

Surgical Wound Clinical Trial

— APOSIT-PTG  

Official title:

Standard Dressing Versus Moist Dressing in the Course of the Postoperative Wound in Patients With Knee Prosthesis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04422119
• Other study ID #: AC-16-016-CEIMPS
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: December 2022

Study information

• Verified date: June 2020
• Source: Germans Trias i Pujol Hospital
• Contact: Sergio Alonso-Fernández, RN,MSN,PhD
• Phone: 0034934978437
• Email: salonso.germanstrias[@]gencat.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is: to evaluate the efficacy of two post-operative dressings in the management of the surgical wounds in patients who received a knee prosthesis

Description:

This was a randomised, controlled, clinical trial on patients who received a primary knee prosthesis in 2018-2019. Treatment group was given a multi-layer foam dressing with Safetac. The control group received standard treatment with povidone-iodine and a gauze dressing with plaster. 50 patients was needed for sufficient power. Primary outcome measures were; the characteristics of the surgical wound, patient reported comfort and adaptability according to the physiotherapist. Secondary outcome measures were: the clinical status and quality of life level according to the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Statistical analysis was performed by using IBM SPSS version 25, with a statistical significance of 5%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Surgical intervention of total primary knee prosthesis

• Informed consent approved and signed by participants.

Exclusion Criteria:

• Sensitivity or allergy to study dressings

Related Conditions & MeSH terms

• Knee Disease
• Surgical Wound
• Wounds and Injuries

Intervention

Procedure:
• Multi-Foam dressing
Application of a multi-layer foam dressing with Safetac in surgical wound
• Usual care
Care of surgical wound with povidone-iodine and a gauze dressing with plaster.

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Germans Trias i Pujol Hospital	Fundació Institut Germans Trias i Pujol

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of dressing changes	Number of dressing applications to the patients required	From fist day post-surgery to 7th postoperative day
Secondary	Change in patient comfort	Patient comfort reported in a scale from 1 (non satisfactory) - to 4 (very satisfactory)	From fist day post-surgery to 7th postoperative day