Wound Dressings Adapted to Wound Exudate and Bacterial Load in Therapy Resistant Large Sized Leg Ulcers
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|ClinicalTrials.gov Identifier: NCT00349700|
Recruitment Status : Completed
First Posted : July 10, 2006
Last Update Posted : May 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Varicose Ulcer||Procedure: Compression: 2 weeks four layer bandages, then stockings Procedure: debridement Procedure: Actisorb plus (r) + Trionic(r)/ Allevyn (r)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||139 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2003|
|Study Completion Date :||May 2005|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349700
|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|