Standard Dressing Versus Moist Dressing in the Course of the Postoperative Wound in Patients With Knee Prosthesis (APOSIT-PTG)
Primary Purpose
Surgical Wound, Knee Disease
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multi-Foam dressing
Usual care
Sponsored by
About this trial
This is an interventional supportive care trial for Surgical Wound focused on measuring Surgical wound healing, knee arthroplasty, postoperative dressings
Eligibility Criteria
Inclusion Criteria:
- Surgical intervention of total primary knee prosthesis
- Informed consent approved and signed by participants.
Exclusion Criteria:
- Sensitivity or allergy to study dressings
Sites / Locations
- Hospital Universitari Germans Trias i PujolRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Multi-layer foam dressing
Usual care
Arm Description
Patients in experimental group will receive the application of a multi-layer foam dressing with Safetac in surgical wound
Patients in control group will receive standard treatment with povidone-iodine and a gauze dressing with plaster.
Outcomes
Primary Outcome Measures
Change in number of dressing changes
Number of dressing applications to the patients required
Secondary Outcome Measures
Change in patient comfort
Patient comfort reported in a scale from 1 (non satisfactory) - to 4 (very satisfactory)
Full Information
NCT ID
NCT04422119
First Posted
December 3, 2019
Last Updated
June 6, 2020
Sponsor
Germans Trias i Pujol Hospital
Collaborators
Fundació Institut Germans Trias i Pujol
1. Study Identification
Unique Protocol Identification Number
NCT04422119
Brief Title
Standard Dressing Versus Moist Dressing in the Course of the Postoperative Wound in Patients With Knee Prosthesis
Acronym
APOSIT-PTG
Official Title
Standard Dressing Versus Moist Dressing in the Course of the Postoperative Wound in Patients With Knee Prosthesis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Germans Trias i Pujol Hospital
Collaborators
Fundació Institut Germans Trias i Pujol
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound, Knee Disease
Keywords
Surgical wound healing, knee arthroplasty, postoperative dressings
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multi-layer foam dressing
Arm Type
Experimental
Arm Description
Patients in experimental group will receive the application of a multi-layer foam dressing with Safetac in surgical wound
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Patients in control group will receive standard treatment with povidone-iodine and a gauze dressing with plaster.
Intervention Type
Procedure
Intervention Name(s)
Multi-Foam dressing
Intervention Description
Application of a multi-layer foam dressing with Safetac in surgical wound
Intervention Type
Procedure
Intervention Name(s)
Usual care
Intervention Description
Care of surgical wound with povidone-iodine and a gauze dressing with plaster.
Primary Outcome Measure Information:
Title
Change in number of dressing changes
Description
Number of dressing applications to the patients required
Time Frame
From fist day post-surgery to 7th postoperative day
Secondary Outcome Measure Information:
Title
Change in patient comfort
Description
Patient comfort reported in a scale from 1 (non satisfactory) - to 4 (very satisfactory)
Time Frame
From fist day post-surgery to 7th postoperative day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Surgical intervention of total primary knee prosthesis
Informed consent approved and signed by participants.
Exclusion Criteria:
Sensitivity or allergy to study dressings
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sergio Alonso-Fernández, RN,MSN,PhD
Phone
0034934978437
Email
salonso.germanstrias@gencat.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Antonia Salmerón-Ramírez, RN
Phone
0034695560386
Email
asalmeronr.germanstrias@gencat.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonia Salmerón-Ramírez, RN
Organizational Affiliation
Germans Trias i Pujol University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergio Alonso-Fernández, RN,MSN,PhD
Phone
0034934978437
Email
salonso.germanstrias@gencat.cat
First Name & Middle Initial & Last Name & Degree
Antonia Salmerón-Ramírez, RN
Phone
0034934973497
First Name & Middle Initial & Last Name & Degree
Antonia Salmerón-Ramírez, RN
First Name & Middle Initial & Last Name & Degree
José Antonio Hernández-Hermoso, MD
First Name & Middle Initial & Last Name & Degree
Juan Alberto Estévez-Moreno, RN
First Name & Middle Initial & Last Name & Degree
Miquel Àngel Barberà-Llorca, RN
First Name & Middle Initial & Last Name & Degree
Nuria Templado Peñaranda, RN
First Name & Middle Initial & Last Name & Degree
Itziar Rodriguez Adrián, RN
First Name & Middle Initial & Last Name & Degree
Maria Llaberia Marcual, PT
First Name & Middle Initial & Last Name & Degree
María del Carmen Blasco-García, RN
First Name & Middle Initial & Last Name & Degree
Sergio Alonso-Fernández, RN,MSN,PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Standard Dressing Versus Moist Dressing in the Course of the Postoperative Wound in Patients With Knee Prosthesis
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