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Wound Dressings Adapted to Wound Exudate and Bacterial Load in Therapy Resistant Large Sized Leg Ulcers
This study has been completed.
First Received: July 7, 2006   No Changes Posted
Sponsored by: Ruhr University of Bochum
Information provided by: Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT00349700
  Purpose

The purpose of the study was to investigated if modern wound dressings adapting to wound exudation and the amount of bacterial colonization can heal large therapy resistant leg ulcers which had a pre-treatment with compresses, ointments and gauze


Condition Intervention
Varicose Ulcer
Procedure: Compression: 2 weeks four layer bandages, then stockings
Procedure: debridement
Procedure: Actisorb plus (r) + Trionic(r)/ Allevyn (r)

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title: An Open Prospective Controlled Trial: Efficiency of Wound Dressings Adapted to Wound Exudate and Bacterial Load in Therapy Resistant Large Sized Leg Ulcers

Resource links provided by NLM:


Further study details as provided by Ruhr University of Bochum:

Primary Outcome Measures:
  • the area of leg ulcers was calculated by multiplication of maximal length and width during the first visit an d at least 6 months after first visit

Estimated Enrollment: 139
Study Start Date: January 2003
Estimated Study Completion Date: May 2005
Detailed Description:

Background: Moist wound therapy of venous leg ulcers is well established by both in vitro or animal studies and studies at ulcers smaller than 20 cm². Mostly larger venous leg ulcers have a stronger exudation than smaller leg ulcers. Therefore larger ulcers exhibit apparently moist conditions also beneath simple gauze, ointments and compresses. The purpose of the study was to investigated if modern wound dressings adapting to wound exudation and the amount of bacterial colonization can heal large therapy resistant leg ulcers which had a pre-treatment with compresses, ointments and gauze. Patients and Methods: In an open, non-randomized prospective trial 139 consecutive patients (86 female, 53 male) with long standing (159 ± 335 weeks) large sized (> 20 cm², 53.8 ± 90.6 cm²) venous ulcers were included. The pre-treatment with compresses, ointments and gauze and two layer short stretch bandages during the time before consulting our wound outpatient department was compared to the following therapy protocol: After two weeks with four layer bandages compression stockings were applied. After a surgical debridement wound dressings were applied according to exudation (strong: calcium alginate, mean: polyurethane foam, low: hydrocolloid). Critical bacterial colonization was treated by activated charcoal cloth with sil-ver. Criteria for evaluating efficacy were healing time and reduction of ulcer size at the end of observation time.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • therapy resistant wounds for at least 3 months
  • venous disease
  • uncle pressure > 80mmHg
  • wound area > 20qcm

Exclusion Criteria:

  • uncle pressure <80mmHg
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00349700

Locations
Germany
St. Josef Hospital, Dep. Dermatology and Allergology, Ruhr University Bochum
Bochum, Germany, 44791
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
Principal Investigator: Peter Altmeyer, Prof. Dr. Ruhr University Bochum, Dep. Dermatology and Allergology
  More Information

No publications provided

Study ID Numbers: 2-Stucker
Study First Received: July 7, 2006
Last Updated: July 7, 2006
ClinicalTrials.gov Identifier: NCT00349700     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ruhr University of Bochum:
healing
skin
infection
wound therapy

Study placed in the following topic categories:
Varicose Ulcer
Varicose Veins
Skin Diseases
Ulcer
Vascular Diseases
Skin Ulcer
Leg Ulcer

Additional relevant MeSH terms:
Varicose Ulcer
Pathologic Processes
Varicose Veins
Skin Diseases
Ulcer
Vascular Diseases
Cardiovascular Diseases
Skin Ulcer
Leg Ulcer

ClinicalTrials.gov processed this record on September 11, 2009