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

NCT ID: NCT00349700

Last Updated: 2016-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2005-05-31

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.

Conditions

Varicose Ulcer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Compression: 2 weeks four layer bandages, then stockings

Intervention Type: PROCEDURE

debridement

Intervention Type: PROCEDURE

Actisorb plus (r) + Trionic(r)/ Allevyn (r)

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• uncle pressure <80mmHg

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruhr University of Bochum

OTHER

Sponsor Role: lead

Principal Investigators

Peter Altmeyer, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Ruhr University Bochum, Dep. Dermatology and Allergology

Locations

St. Josef Hospital, Dep. Dermatology and Allergology, Ruhr University Bochum

Bochum, , Germany

Countries

Germany

Other Identifiers

2-Stucker

Identifier Type: -

Identifier Source: org_study_id