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Sponsored by: |
Ruhr University of Bochum |
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Information provided by: | Ruhr University of Bochum |
ClinicalTrials.gov Identifier: | NCT00349700 |
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 |
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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 |
Estimated Enrollment: | 139 |
Study Start Date: | January 2003 |
Estimated Study Completion Date: | May 2005 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
St. Josef Hospital, Dep. Dermatology and Allergology, Ruhr University Bochum | |
Bochum, Germany, 44791 |
Principal Investigator: | Peter Altmeyer, Prof. Dr. | Ruhr University Bochum, Dep. Dermatology and Allergology |
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 |
healing skin infection wound therapy |
Varicose Ulcer Varicose Veins Skin Diseases Ulcer |
Vascular Diseases Skin Ulcer Leg Ulcer |
Varicose Ulcer Pathologic Processes Varicose Veins Skin Diseases Ulcer |
Vascular Diseases Cardiovascular Diseases Skin Ulcer Leg Ulcer |