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

NCT00343824 | Completed

• 1 other identifier: 2006/224
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Burn Wounds - Partial Thickness (2nd Degree)

Keywords

Burn wounds - Silver Dressings - Bacterial Control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Comparison of blood silver levels

  Every week until woundhealing. In folluw-up: at 3, 6 and 12 months

• Percentage of genetically-acquired resistance to silver

  Once after wound closure.

• Healing time comparison

  Every 3 days until healing

• Scar quality assessment

  At 1, 3, 6 and 12 months after wound closure

• Cost-effectiveness

  Once after wound closure.

Study Arms (2)

aquacel AG hydrofiber

EXPERIMENTAL

Procedure: aquacel AG hydrofiber versus acticoat burn dressing

Acticoat burn dressing

EXPERIMENTAL

Procedure: aquacel AG hydrofiber versus acticoat burn dressing

Interventions

aquacel AG hydrofiber versus acticoat burn dressing PROCEDURE

Aquacel AG hydrofiber versus acticoat burn dressing will be compared.

Acticoat burn dressing; aquacel AG hydrofiber

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

• Website of the University Hospital Ghent

Study Officials

• Stan Monstrey, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2006
• First Posted: June 23, 2006
• Study Start: November 1, 2006
• Primary Completion: July 31, 2010
• Study Completion: July 31, 2010
• Last Updated: December 21, 2022

Record last verified: 2022-12

Locations

BE (1)