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

Sponsor

Ruhr University of Bochum (Other)

Overall Status

Completed

CT.gov ID

NCT00349700

Collaborator

(none)

139

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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)	N/A

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.

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 Design

Study Type:

Interventional

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 :

Jan 1, 2003

Study Completion Date :

May 1, 2005

Outcome Measures

Primary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

uncle pressure <80mmHg

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Josef Hospital, Dep. Dermatology and Allergology, Ruhr University Bochum	Bochum		Germany	44791

Sponsors and Collaborators

Ruhr University of Bochum

Investigators

Principal Investigator: Peter Altmeyer, Prof. Dr., Ruhr University Bochum, Dep. Dermatology and Allergology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00349700

Other Study ID Numbers:

2-Stucker

First Posted:

Jul 10, 2006

Last Update Posted:

May 6, 2016

Last Verified:

Jul 1, 2006

Keywords provided by , ,

Additional relevant MeSH terms:

Varicose Ulcer

Leg Ulcer

Ulcer

Study Results

No Results Posted as of May 6, 2016