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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

University Hospital, Ghent

ClinicalTrials.gov Identifier:

NCT00343824

First received: June 21, 2006

Last updated: February 1, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 21, 2006

Last Updated Date

February 1, 2013

Start Date ^ICMJE

August 2006

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Evaluation of the efficacy of both wound dressings in controlling wound bioburden over a period of 21 days

Change History

Complete list of historical versions of study NCT00343824 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Comparison of blood silver levels [ Time Frame: Every week until woundhealing. In folluw-up: at 3, 6 and 12 months ] [ Designated as safety issue: No ]
Percentage of genetically-acquired resistance to silver [ Time Frame: Once after wound closure. ] [ Designated as safety issue: No ]
Healing time comparison [ Time Frame: Every 3 days until healing ] [ Designated as safety issue: No ]
Scar quality assessment [ Time Frame: At 1, 3, 6 and 12 months after wound closure ] [ Designated as safety issue: No ]
Cost-effectiveness [ Time Frame: Once after wound closure. ] [ Designated as safety issue: No ]
Health related quality of life [ Time Frame: At 1, 3, 6 and 12 months after wound closure ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Comparison of blood silver levels
Percentage of genetically-acquired resistance to silver
Healing time comparison
Scar quality assessment
Cost-effectiveness
Health related quality of life

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Burn Wounds - Partial Thickness (2nd Degree)

Intervention ^ICMJE

Procedure: aquacel AG hydrofiber versus acticoat burn dressing

Aquacel AG hydrofiber versus acticoat burn dressing will be compared.

Study Arm (s)

Experimental: aquacel AG hydrofiber
Intervention: Procedure: aquacel AG hydrofiber versus acticoat burn dressing
Experimental: Acticoat burn dressing
Intervention: Procedure: aquacel AG hydrofiber versus acticoat burn dressing

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

September 2013

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT00343824

Other Study ID Numbers ^ICMJE

2006/224

Has Data Monitoring Committee

Responsible Party

University Hospital, Ghent

Study Sponsor ^ICMJE

University Hospital, Ghent

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Stan Monstrey, MD, PhD

University Hospital, Ghent

Information Provided By

University Hospital, Ghent

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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