MedDataX Logo

Bacterial Control in Partial Thickness Burns Using Silver-containing Wound Dressings

NCT ID: NCT00343824

Last Updated: 2022-12-21

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

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-01

Study Completion Date

2010-07-31

Brief Summary

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

This study is to compare the treatment with two different silver-containing wound dressings: aquacel AG hydrofiber versus acticoat burn 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.

Burn Wounds - Partial Thickness (2nd Degree)

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Burn wounds - Silver Dressings - Bacterial Control

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

aquacel AG hydrofiber

Group Type EXPERIMENTAL

aquacel AG hydrofiber versus acticoat burn dressing

Intervention Type PROCEDURE

Aquacel AG hydrofiber versus acticoat burn dressing will be compared.

Acticoat burn dressing

Group Type EXPERIMENTAL

aquacel AG hydrofiber versus acticoat burn dressing

Intervention Type PROCEDURE

Aquacel AG hydrofiber versus acticoat burn dressing will be compared.

Interventions

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

aquacel AG hydrofiber versus acticoat burn dressing

Aquacel AG hydrofiber versus acticoat burn dressing will be compared.

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* Burn wounds with flux values, measured by Laser Doppler Imaging, corresponding with expected healing time between 7 and 21 days, flux values between 200 and 1000 (red-pink or pink-yellow-green colour)
* Wounds treated with a hydrocolloid paste prior to LDI
* Possibility to follow the complete treatment schedule until wound healing and participation on complete follow-up schedule
* Informed consent
* Partial thickness burns with TBSE \< 40%

Exclusion Criteria

* Mean flux values \< 200 or \> 1000
* TBSA \> 40%
* Impossibility to debride necrotic skin prior to LDI measurement
* Wounds treated with any topical ointments or dressings other than hydrocolloid prior to LDI
* Not following the complete treatment schedule or missing some evaluations during the follow-up period
* Patient has any condition that seriously compromises the patient's ability to complete the study
* Patient has participated in another study using an investigational drug within the previous 30 days
* Patient has one or more medical condition(s)that in the opinion of the investigator would make the patient an inappropriate candidate for this study
* The plastic surgeon decides that surgery is necessary due to unusual circumstances
* Patient wish to decline from the study
* No informed consent
* Full thickness burns
Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stan Monstrey, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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

University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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

Belgium

Related Links

Access external resources that provide additional context or updates about the study.

http://www.uzgent.be

Website of the University Hospital Ghent

Other Identifiers

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

2006/224

Identifier Type: -

Identifier Source: org_study_id