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

University Hospital, Ghent1 site in 1 country100 target enrollmentNovember 1, 2006

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Burn Wounds - Partial Thickness (2nd Degree)
Sponsor: University Hospital, Ghent
Enrollment: 100
Locations: 1
Primary Endpoint: Evaluation of the efficacy of both wound dressings in controlling wound bioburden over a period of 21 days
Status: Completed
Last Updated: 3 years ago

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

Registry

clinicaltrials.gov

Start Date

November 1, 2006

End Date

July 31, 2010

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Responsible Party

Sponsor

•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%

•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

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

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