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

G

Ghent University Hospital (UZ)

Status

Completed

Conditions

Burn Wounds - Partial Thickness (2nd Degree)

Treatments

Procedure: aquacel AG hydrofiber versus acticoat burn dressing

Study type

Interventional

Funder types

Other

Identifiers

NCT00343824
2006/224

Details and patient eligibility

About

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

Enrollment

100 patients

Sex

All

Ages

Under 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 2 patient groups

aquacel AG hydrofiber
Experimental group
Treatment:
Procedure: aquacel AG hydrofiber versus acticoat burn dressing
Acticoat burn dressing
Experimental group
Treatment:
Procedure: aquacel AG hydrofiber versus acticoat burn dressing

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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