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 Locations
-
-
Barcelona
-
Badalona, Barcelona, Spain, 08916
- Recruiting
- Hospital Universitari Germans Trias i Pujol
-
Contact:
- Sergio Alonso-Fernández, RN,MSN,PhD
- Phone Number: 0034934978437
- Email: salonso.germanstrias@gencat.cat
-
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
|
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.
|
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
Collaborators
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
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.