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

Study Overview
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Brief Summary
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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
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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%.

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

Conditions
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Surgical Wound, Knee Disease

Intervention / Treatment
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* Procedure: Multi-Foam dressing
* Procedure: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Surgical intervention of total primary knee prosthesis Informed consent approved and signed by participants. Exclusion Criteria: Sensitivity or allergy to study dressings

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-layer foam dressing<br>Patients in experimental group will receive the application of a multi-layer foam dressing with Safetac in surgical wound | Procedure: Multi-Foam dressing<br>* Application of a multi-layer foam dressing with Safetac in surgical wound<br>|
| Active Comparator: Usual care<br>Patients in control group will receive standard treatment with povidone-iodine and a gauze dressing with plaster. | Procedure: Usual care<br>* Care of surgical wound with povidone-iodine and a gauze dressing with plaster.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of dressing changes | Number of dressing applications to the patients required | From fist day post-surgery to 7th postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical wound healing, knee arthroplasty, postoperative dressings