A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.

Part of paid clinical trials in Castro Valley, California.

Sponsor
Molnlycke Health Care AB
Study ID
NCT05588583
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mepilex Up — DEVICE
    Mepilex Up is a highly conformable dressing that absorbs both low and high viscous exudates, maintains a moist wound environment and minimises the risk of maceration. The dressing has a Safetac® wound contact layer that is a unique adhesive technology. It minimises pain to patients and trauma to wounds and the surrounding skin at dressing removal. Mepilex Up consists of: * a soft silicone wound contact layer (Safetac) * a flexible absorbent pad of compressed polyurethane foam * an outer polyurethane film which is breathable but waterproof Dressing material content: Silicone, polyurethane

Study Details

The goal of this clinical trial is to follow the progress of wounds in those with venous leg ulcers and diabetic foot ulcers while using an absorbent dressing called Mepilex Up. 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 Mepilex Up dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.

Key Dates

Start date
Oct 31, 2022
Status verified
Oct 2022
Primary completion
Mar 31, 2024
Completion
Mar 31, 2024

Study Design

Enrollment
68 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Supportive Care with Mepilex Up
    All Subjects will use a soft, silicone, non-bordered, adhesive, foam dressing called Mepilex Up as the absorbent primary dressing.

Primary Outcome Measure

Wound progress of the total effect of treatment using Mepilex Up [ 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

Locations (4)

FacilityCityStateZIPSite coordinators
Center for Clinical Research, Inc.Castro ValleyCalifornia94546
Gayana Sarkisova, CCRC
[email protected]
800-363-1069
Alexander Reyzelman, DPM (PRINCIPAL_INVESTIGATOR)
Felix Sigal, DPMLos AngelesCalifornia90010
Maira Jackson, MA
[email protected]
Felix Sigal, DPM (PRINCIPAL_INVESTIGATOR)
University of MiamiMiamiFlorida33125
Aliette Espinosa
[email protected]
305-689-3376
Hadar Lev-Tov, MD (PRINCIPAL_INVESTIGATOR)
Serena Group Research InstitutePittsburghPennsylvania15222
Laura Serena
[email protected]
412-335-0764
Thomas Serena, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Castro Valley, CA

By research site
Center for Clinical Research, Inc.· Castro Valley, CAFelix Sigal, DPM· Los Angeles, CAUniversity of Miami· Miami, FLSerena Group Research Institute· Pittsburgh, PA

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