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

NCT ID: NCT04422119

Last Updated: 2020-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2022-12-31

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%.

Conditions

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Surgical Wound Knee Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Multi-layer foam dressing

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

Group Type EXPERIMENTAL

Multi-Foam dressing

Intervention Type PROCEDURE

Application of a multi-layer foam dressing with Safetac in surgical wound

Usual care

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

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type PROCEDURE

Care of surgical wound with povidone-iodine and a gauze dressing with plaster.

Interventions

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Multi-Foam dressing

Application of a multi-layer foam dressing with Safetac in surgical wound

Intervention Type PROCEDURE

Usual care

Care of surgical wound with povidone-iodine and a gauze dressing with plaster.

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundació Institut Germans Trias i Pujol

OTHER

Sponsor Role collaborator

Germans Trias i Pujol Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonia Salmerón-Ramírez, RN

Role: PRINCIPAL_INVESTIGATOR

Germans Trias i Pujol Hospital

Locations

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Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Sergio Alonso-Fernández, RN,MSN,PhD

Role: CONTACT

0034934978437

Antonia Salmerón-Ramírez, RN

Role: CONTACT

0034695560386

Facility Contacts

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Sergio Alonso-Fernández, RN,MSN,PhD

Role: primary

0034934978437

Antonia Salmerón-Ramírez, RN

Role: backup

0034934973497

Other Identifiers

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AC-16-016-CEIMPS

Identifier Type: -

Identifier Source: org_study_id

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