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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

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

salonso.germanstrias@gencat.cat

First Name & Middle Initial & Last Name or Official Title & Degree

Antonia Salmerón-Ramírez, RN

Phone

0034695560386

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

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

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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