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
  Purpose

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


Condition Intervention
Burn Wounds - Partial Thickness (2nd Degree)
Procedure: aquacel AG hydrofiber versus acticoat burn dressing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bacterial Control in Partial Thickness Burns Using Silver-containing Wound Dressings

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: August 2006
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aquacel AG hydrofiber Procedure: aquacel AG hydrofiber versus acticoat burn dressing
Aquacel AG hydrofiber versus acticoat burn dressing will be compared.
Experimental: Acticoat burn dressing Procedure: aquacel AG hydrofiber versus acticoat burn dressing
Aquacel AG hydrofiber versus acticoat burn dressing will be compared.

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343824

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Stan Monstrey, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00343824     History of Changes
Other Study ID Numbers: 2006/224
Study First Received: June 21, 2006
Last Updated: February 1, 2013
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:
Burn wounds - Silver Dressings - Bacterial Control

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014