Overview

This trial is active, not recruiting.

Condition burn wounds - partial thickness (2nd degree)
Treatment aquacel ag hydrofiber versus acticoat burn dressing
Sponsor University Hospital, Ghent
Start date August 2006
End date September 2015
Trial size 100 participants
Trial identifier NCT00343824, 2006/224

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
aquacel ag hydrofiber versus acticoat burn dressing
Aquacel AG hydrofiber versus acticoat burn dressing will be compared.
(Experimental)
aquacel ag hydrofiber versus acticoat burn dressing
Aquacel AG hydrofiber versus acticoat burn dressing will be compared.

Primary Outcomes

Measure
Evaluation of the efficacy of both wound dressings in controlling wound bioburden over a period of 21 days
time frame: Over a period of 21 days

Secondary Outcomes

Measure
Comparison of blood silver levels
time frame: Every week until woundhealing. In folluw-up: at 3, 6 and 12 months
Percentage of genetically-acquired resistance to silver
time frame: Once after wound closure.
Healing time comparison
time frame: Every 3 days until healing
Scar quality assessment
time frame: At 1, 3, 6 and 12 months after wound closure
Cost-effectiveness
time frame: Once after wound closure.
Health related quality of life
time frame: At 1, 3, 6 and 12 months after wound closure

Eligibility Criteria

Male or female participants up to 80 years old.

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

Additional Information

Official title Bacterial Control in Partial Thickness Burns Using Silver-containing Wound Dressings
Principal investigator Stan Monstrey, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University Hospital, Ghent.