Aquacel With Strengthening Fiber (WSF) Ribbon Dressings | NCT07308665

Studies
Aquacel With Strengthening Fiber (WSF) Ribbon Dressings

NCT07308665

Sponsor

ConvaTec Inc.

Status

Completed

Last Update Posted

Dec 30, 2025Actual

Enrollment

214Actual

Phase

Not provided

Conditions

Ulcer Foot
Ulcer Healing
Wound Infection

Interventions

Aquacel Ribbon

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Apr 8, 2025Actual

Completion Date

Sep 17, 2025Actual

First Submitted Date

Dec 17, 2025

First Submission Date that Met QC Criteria

Dec 17, 2025

First Posted Date

Dec 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2025

Last Update Posted Date

Dec 30, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

214Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aquacel Ribbon		Aquacel WSF Ribbon treatment	Device: Aquacel Ribbon

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aquacel Ribbon	Device	Subjects who received an Aquacel WSF Ribbon	Aquacel Ribbon

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Wound size	Measured size (area, volume) of target wound at each visit	Baseline and week 4, 12, 20
Wound dept	Measured wound depth at each visit

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Christina Mastandrea	ConvaTec Inc.	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D016523	Foot Ulcer
D014946	Wound Infection

Ancestor Terms

ID	Term
D005534	Foot Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D007871	Leg Ulcer

Browse Leaves

Not provided

Browse Branches

Not provided