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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
Sponsor:
Information provided by:
Ruhr University of Bochum

Brief Summary:
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 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

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 139 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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Primary Outcome Measures :
  1. 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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


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

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ClinicalTrials.gov Identifier: NCT00349700    
Other Study ID Numbers: 2-Stucker
First Posted: July 10, 2006    Key Record Dates
Last Update Posted: May 6, 2016
Last Verified: July 2006
Keywords provided by Ruhr University of Bochum:
healing
skin
infection
wound therapy
Additional relevant MeSH terms:
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Varicose Ulcer
Leg Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases