Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00343824
NCT00343824CompletedNot Applicable

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

University Hospital, Ghent1 site in 1 country100 target enrollmentStarted: November 1, 2006Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
Evaluation of the efficacy of both wound dressings in controlling wound bioburden over a period of 21 days
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
— to 80 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

aquacel AG hydrofiber

Experimental

Intervention: aquacel AG hydrofiber versus acticoat burn dressing (Procedure)

Acticoat burn dressing

Experimental

Intervention: aquacel AG hydrofiber versus acticoat burn dressing (Procedure)

Outcomes

Primary Outcomes

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

  • Cost-effectiveness(Once after wound closure.)
  • Comparison of blood silver levels(Every week until woundhealing. In folluw-up: at 3, 6 and 12 months)
  • Scar quality assessment(At 1, 3, 6 and 12 months after wound closure)
  • Percentage of genetically-acquired resistance to silver(Once after wound closure.)
  • Health related quality of life(At 1, 3, 6 and 12 months after wound closure)
  • Healing time comparison(Every 3 days until healing)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
PORCINE XENOGRAFT OR MICROBIAL CELLULOSE IN THE TREATMENT OF PARTIAL THICKNESS BURNSBurn ScarBurn Second DegreeBurns
NCT04412759University Hospital, Linkoeping26
Not yet recruiting
Phase 3
Bacterial nanocellulose wound dressings for the healing of second degree burn woundsSecond degree burn ulcer.Calcification and ossification of muscles associated with burnsM61.3
IRCT20160117026069N6Karaj University of Medical Sciences24
Completed
Not Applicable
To Study the Healing Effect of Silver Impregnated Activated Carbon Fiber Wound Dressing on Superficial Dermal BurnBurns
NCT01598480Bio-medical Carbon Technology Co., Ltd.30
Completed
Not Applicable
To Study the Healing Effect of Silver Impregnated Activated Carbon Fiber Wound Dressing on Deep Dermal BurnBurns
NCT01598493Bio-medical Carbon Technology Co., Ltd.30
Terminated
Not Applicable
Alginate Dressings Versus Gauge Dressings After Pilonidal Cyst Resection: Examination of the Quality of LifePilonidal Cyst/Fistula
NCT03757572Larissa University Hospital65