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

G

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)

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

Trial contacts and locations

1

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Central trial contact

Sergio Alonso-Fernández, RN,MSN,PhD; Antonia Salmerón-Ramírez, RN

Data sourced from clinicaltrials.gov

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