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

June 6, 2020 updated by: Germans Trias i Pujol Hospital
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Hospital Universitari Germans Trias i Pujol
        • Contact:
        • Contact:
          • Antonia Salmerón-Ramírez, RN
          • Phone Number: 0034934973497
        • Principal Investigator:
          • Antonia Salmerón-Ramírez, RN
        • Sub-Investigator:
          • José Antonio Hernández-Hermoso, MD
        • Sub-Investigator:
          • Juan Alberto Estévez-Moreno, RN
        • Sub-Investigator:
          • Miquel Àngel Barberà-Llorca, RN
        • Sub-Investigator:
          • Nuria Templado Peñaranda, RN
        • Sub-Investigator:
          • Itziar Rodriguez Adrián, RN
        • Sub-Investigator:
          • Maria Llaberia Marcual, PT
        • Sub-Investigator:
          • María del Carmen Blasco-García, RN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in number of dressing changes
Time Frame: From fist day post-surgery to 7th postoperative day
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
Time Frame: From fist day post-surgery to 7th postoperative day
Patient comfort reported in a scale from 1 (non satisfactory) - to 4 (very satisfactory)
From fist day post-surgery to 7th postoperative day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Germans Trias i Pujol Hospital

Collaborators

Fundació Institut Germans Trias i Pujol

Investigators

  • Principal Investigator: Antonia Salmerón-Ramírez, RN, Germans Trias i Pujol University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

December 3, 2019

First Submitted That Met QC Criteria

June 6, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

June 9, 2020

Last Update Submitted That Met QC Criteria

June 6, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-16-016-CEIMPS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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