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

Not Applicable

Completed

• Conditions: Varicose Ulcer

• Registration Number: NCT00349700
• Lead Sponsor: 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

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.

Study Timeline

• Study Start: 2003-01
• Study Completion: 2005-05
• Status Verified: 2006-07
• Study First Submitted: 2006-07-07
• Study First Submitted QC: 2006-07-07
• Study First Posted: 2006-07-10
• Last Update Submitted: 2016-05-05
• Last Update Posted: 2016-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

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

Exclusion Criteria

• uncle pressure <80mmHg

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

St. Josef Hospital, Dep. Dermatology and Allergology, Ruhr University Bochum; 🇩🇪 Bochum, Germany