Clinical Comparative Trial of a Modified Polyurethane Dressing and Aquacel

NCT ID: NCT01055925

Last Updated: 2010-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The almost single disadvantage of conventional polyurethane film dressings, an uncontrolled leakage, is probably as often described as its numerous advantages for split-thickness skin graft (STSG) donor sites. This shortcoming can be overcome by perforating the polyurethane dressing (MPD), which permits a controlled leakage into a secondary absorbent dressing. The study was conducted to compare the MPD-system and Aquacel® (ConvaTec), a hydrofiber wound dressing, which also seems to fulfill all criteria of an ideal donor site dressing.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Reepithelialization of Skin Graft Donor Sites

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MPV

Group Type ACTIVE_COMPARATOR

modified polyurethane film dressing (OpSite, Smith&Nephew, London, UK)

Intervention Type DEVICE

Aquacel

Group Type ACTIVE_COMPARATOR

Aquacel® (ConvaTec, Skillman, NJ, USA), sodium carboxy-methylcellulose hydrocolloid polymer dressing

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

modified polyurethane film dressing (OpSite, Smith&Nephew, London, UK)

Intervention Type DEVICE

Aquacel® (ConvaTec, Skillman, NJ, USA), sodium carboxy-methylcellulose hydrocolloid polymer dressing

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* skin graft donor site anterolateral thigh
* men and women \> 18 years

Exclusion Criteria

* informed consent missing
* repeated skin graft take or prior injury at the observed site
* Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
* History of hypersensitivity to the investigational products
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Klinik Bogenhausen

OTHER

Sponsor Role lead

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Plastic, Reconstructive, Hand and Burn Surgery, Academic Hospital Munich Bogenhausen, Technical University Munich

Munich, Bavaria, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MPV-AQUACEL

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Epidermal Grafting in Wound Healing
NCT02535481 COMPLETED NA
Impact of Prisma on Donor Site Pain
NCT04050124 COMPLETED NA