Wound Dressings Adapted to Wound Exudate and Bacterial Load in Therapy Resistant Large Sized Leg Ulcers

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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An Open Prospective Controlled Trial: Efficiency of Wound Dressings Adapted to Wound Exudate and Bacterial Load in Therapy Resistant Large Sized Leg Ulcers

Conditions
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Varicose Ulcer

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: therapy resistant wounds for at least 3 months venous disease uncle pressure > 80mmHg wound area > 20qcm Exclusion Criteria: uncle pressure <80mmHg

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Compression: 2 weeks four layer bandages, then stockings|nan|
|Procedure: debridement|nan|
|Procedure: Actisorb plus (r) + Trionic(r)/ Allevyn (r)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healing, skin, infection, wound therapy