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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
  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:

MedlinePlus related topics: Burns
U.S. FDA Resources

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
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:
Website of the University Hospital Ghent  This link exits the ClinicalTrials.gov site

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 May 19, 2013