Standard Dressing Versus Moist Dressing in the Course of the Postoperative Wound in Patients With Knee Prosthesis (APOSIT-PTG)

Germans Trias i Pujol Hospital

Status: Unknown

Conditions: Surgical Wound; Knee Disease

Treatments: Procedure: Usual care; Procedure: Multi-Foam dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT04422119

AC-16-016-CEIMPS

Details and patient eligibility

About

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

Full 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%.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Sensitivity or allergy to study dressings

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Multi-layer foam dressing

Experimental group

Description:

Patients in experimental group will receive the application of a multi-layer foam dressing with Safetac in surgical wound

Treatment:

Procedure: Multi-Foam dressing

Usual care

Active Comparator group

Description:

Patients in control group will receive standard treatment with povidone-iodine and a gauze dressing with plaster.

Treatment:

Procedure: Usual care