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

Burn Wounds - Partial Thickness (2nd Degree) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00343824
• Other study ID #: 2006/224
• Status: Completed
• Phase: N/A
• Start date: November 1, 2006
• Est. completion date: July 31, 2010

Study information

• Verified date: December 2022
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 31, 2010
• Est. primary completion date: July 31, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Burn Wounds - Partial Thickness (2nd Degree)
• Burns
• Wounds and Injuries

Intervention

Procedure:
• aquacel AG hydrofiber versus acticoat burn dressing
Aquacel AG hydrofiber versus acticoat burn dressing will be compared.

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

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

External Links

•   Website of the University Hospital Ghent