Aquacel With Strengthening Fiber (WSF) Ribbon Dressings

December 17, 2025 updated by: ConvaTec Inc.

A Multi-site Retrospective Study of the Real-world Performance of Aquacel With Strengthening Fiber (WSF) Ribbon Dressings

Retrospective, multi-site, non-comparative, post-market study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Retrospective, multi-site, non-comparative, post-market study to evaluate real-world performance of Aquacel WSF Ribbon dressings in wound healing

Study Type

Observational

Enrollment (Actual)

214

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients who received an Aquacel WSF Ribbon dressing and who's data was collected in Wound Care Advantage (WCA).

Description

Inclusion Criteria:

  • Subjects who have received one or more Aquacel WSF Ribbon dressing

Exclusion Criteria:

  • Patients who have not received one or more Aquacel WSF Ribbon 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Aquacel Ribbon
Aquacel WSF Ribbon treatment
Device: Aquacel Ribbon
Subjects who received an Aquacel WSF Ribbon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Real-world efficacy of Aquacel WSF Ribbon in improving the incidence of wound closure
Time Frame: Baseline and week 4, 12, 20
Time to complete wound closure, defined as 100% epithelialization of the wound surface
Baseline and week 4, 12, 20

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound size
Time Frame: Baseline and week 4, 12, 20
Measured size (area, volume) of target wound at each visit
Baseline and week 4, 12, 20
Wound dept
Time Frame: Baseline and week 4, 12, 20
Measured wound depth at each visit
Baseline and week 4, 12, 20
Exudate volume
Time Frame: Baseline and week 4, 12, 20
Changes in exudate volume
Baseline and week 4, 12, 20
Application use
Time Frame: Up to week 20
Number of Aquacel WSF Ribbon applications per subject over treatment course
Up to week 20
Visit frequency
Time Frame: Up to week 20
Number of visit frequency
Up to week 20
Dressing wear time
Time Frame: Baseline and week 4, 12, 20
Aquacel WSF Ribbon wear time
Baseline and week 4, 12, 20

Collaborators and Investigators

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

Sponsor

ConvaTec Inc.

Investigators

  • Study Director: Christina Mastandrea, ConvaTec Inc.

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)

January 1, 2017

Primary Completion (Actual)

April 8, 2025

Study Completion (Actual)

September 17, 2025

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

December 17, 2025

First Posted (Actual)

December 30, 2025

Study Record Updates

Last Update Posted (Actual)

December 30, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WC-24-450

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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