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

Not Applicable

Completed

• Conditions: Burn Wounds - Partial Thickness (2nd Degree)
• Interventions: Procedure: aquacel AG hydrofiber versus acticoat burn dressing

• Registration Number: NCT00343824
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-06-21
• Study First Submitted QC: 2006-06-21
• Study First Posted: 2006-06-23
• Study Start: 2006-11-01
• Primary Completion: 2010-07-31
• Study Completion: 2010-07-31
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-18
• Last Update Posted: 2022-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
aquacel AG hydrofiber	aquacel AG hydrofiber versus acticoat burn dressing	-
Acticoat burn dressing	aquacel AG hydrofiber versus acticoat burn dressing	-

Primary Outcome Measures

Name	Time	Method
Evaluation of the efficacy of both wound dressings in controlling wound bioburden over a period of 21 days	Over a period of 21 days

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium