NCT04422119

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2019

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

4.5 years

First QC Date

December 3, 2019

Last Update Submit

June 6, 2020

Conditions

Surgical WoundKnee Disease

Keywords

Surgical wound healingknee arthroplastypostoperative dressings

Outcome Measures

Primary Outcomes (1)

  • Change in number of dressing changes

    Number of dressing applications to the patients required

    From fist day post-surgery to 7th postoperative day

Secondary Outcomes (1)

  • Change in patient comfort

    From fist day post-surgery to 7th postoperative day

Study Arms (2)

Multi-layer foam dressing

EXPERIMENTAL

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

Procedure: Multi-Foam dressing

Usual care

ACTIVE COMPARATOR

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

Procedure: Usual care

Interventions

Multi-Foam dressingPROCEDURE

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

Multi-layer foam dressing
Usual carePROCEDURE

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

Usual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Surgical intervention of total primary knee prosthesis
  • Informed consent approved and signed by participants.

You may not qualify if:

  • Sensitivity or allergy to study dressings

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

RECRUITING

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Antonia Salmerón-Ramírez, RN

    Germans Trias i Pujol Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergio Alonso-Fernández, RN,MSN,PhD

CONTACT

0034934978437salonso.germanstrias@gencat.cat

Antonia Salmerón-Ramírez, RN

CONTACT

0034695560386asalmeronr.germanstrias@gencat.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2019

First Posted

June 9, 2020

Study Start

June 1, 2018

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

June 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)