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OpenTrials
Completed

NCT Number: NCT00343824

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

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

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Key information

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aquacel AG hydrofiber versus acticoat burn dressing

Procedure

Aquacel AG hydrofiber versus acticoat burn dressing will be compared.

Primary outcomes

  1. 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

Secondary outcomes

  1. Comparison of blood silver levels

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

  2. Percentage of genetically-acquired resistance to silver

    Time frame: Once after wound closure.

  3. Healing time comparison

    Time frame: Every 3 days until healing

  4. Scar quality assessment

    Time frame: At 1, 3, 6 and 12 months after wound closure

  5. Cost-effectiveness

    Time frame: Once after wound closure.

  6. Health related quality of life

    Time frame: At 1, 3, 6 and 12 months after wound closure

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jun 23, 2006
Registry last updated
Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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