Recruiting

Non-Bordered Foam Dressing

Sponsor:

Molnlycke Health Care AB

Code:

NCT05608317

Conditions

Wounds

Wound of Skin

Wound Leg

Venous Leg Ulcer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ALLEVYN Non-Adhesive

Study Details

Brief summary:

The goal of this clinical trial to follow the progress of wounds in those with chronic venous leg ulcers while using a non-bordered foam dressing. The main objective is to follow the progress of these wounds over time from initial visit to each follow-up visit.

Participants will be asked to wear the dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.

Conditions

Wounds

Wound of Skin

Wound Leg

Venous Leg Ulcer

Study ID

NCT05608317

Start date

Nov 8, 2022

Status verified date

May, 2024

Completion date

Nov 30, 2024

Anticipated

Primary completion date

Jul 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Signed consent to participate (including consent for digital imaging)
  • Adult aged ≥18 years
  • Diagnosed with a chronic, exuding VLU
  • Exudate amount moderate to large
  • Wound size from 3 cm2 to 30 cm2, as determined by the clinician
  • ABPI (within 3 months) > 0.7. If ABPI > 1.4, then big toe pressure > 60 mmHg is required or an alternative measurement verifying normal distal arterial flow
  • Willing to be compliant with compression therapy

Exclusion Criteria:

  • Infected ulcer according to the judgment of the investigator defined as any wound condition requiring the prescription or continuation of systemic antibiotic therapy at enrollment
  • Circumferential wound
  • Known allergy/hypersensitivity to the materials of the dressing
  • Use of wound fillers

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Supportive Care with Non-Bordered Foam Dressing

All Subjects will use a non-bordered foam dressing as the absorbent primary dressing.

Interventions

ALLEVYN Non-Adhesive

ALLEVYN Non-Adhesive combines patient comfort with the tri-layer fluid management system that enables moist wound healing. It utilizes a unique triple action technology that manages fluid to maintain optimal moist wound healing conditions. It is ideal for fragile and sensitive skin due to its non-adherent wound contact layer and soft and conformable construction.

ALLEVYN Non-Adhesive consists of the following layers:

  • Breathable top film
  • Highly absorbent foam core
  • Non-adhesive wound contact layer

Primary outcome measure

  • Wound progress of the total effect of treatment using ALLEVYN Non-Adhesive [ Time Frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. ]

Central Contacts and Locations

Central contacts

Janet Kandrevas, MD, MS

734-358-2174janet.kandrevas@molnlycke.com

Andrea Picchietti, MS, CCRA

260-258-3879andrea.picchietti@molnlycke.com

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33125

Contacts

Aliette Espinosa

305-689-3376a.espinosa2@med.miami.edu

Principal Investigator:

Hadar Lev-Tov, MD

Serena Group Research Institute

Recruiting

Pittsburgh, Pennsylvania, United States, 15222

Contacts

Laura Serena

412-335-0764lserena@serenagroups.com

Principal Investigator:

Thomas Serena, MD

More Information

Sponsor

Molnlycke Health Care AB

Last update posted

May 6, 2024

Last verified

May, 2024

Keywords

  • Venous Leg Ulcer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-21. This information was provided to ClinicalTrials.gov by Molnlycke Health Care AB on 2024-05-06.