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

Not Applicable

• Conditions: Surgical Wound; Knee Disease
• Interventions: Procedure: Usual care; Procedure: Multi-Foam dressing

• Registration Number: NCT04422119
• Lead Sponsor: Germans Trias i Pujol Hospital

Brief 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

Detailed 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%.

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2019-12-03
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-06
• Last Update Submitted: 2020-06-06
• Study First Posted: 2020-06-09
• Last Update Posted: 2020-06-09
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Surgical intervention of total primary knee prosthesis
• Informed consent approved and signed by participants.

Exclusion Criteria

• Sensitivity or allergy to study dressings

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Usual care	Patients in control group will receive standard treatment with povidone-iodine and a gauze dressing with plaster.
Multi-layer foam dressing	Multi-Foam dressing	Patients in experimental group will receive the application of a multi-layer foam dressing with Safetac in surgical wound

Primary Outcome Measures

Name	Time	Method
Change in number of dressing changes	From fist day post-surgery to 7th postoperative day	Number of dressing applications to the patients required

Secondary Outcome Measures

Name	Time	Method
Change in patient comfort	From fist day post-surgery to 7th postoperative day	Patient comfort reported in a scale from 1 (non satisfactory) - to 4 (very satisfactory)

Trial Locations

Locations (1)

Hospital Universitari Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain