Wound Dressings Adapted to Wound Exudate and Bacterial Load in Therapy Resistant Large Sized Leg Ulcers
Primary Purpose
Varicose Ulcer
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Compression: 2 weeks four layer bandages, then stockings
debridement
Actisorb plus (r) + Trionic(r)/ Allevyn (r)
Sponsored by
About this trial
This is an interventional treatment trial for Varicose Ulcer focused on measuring healing, skin, infection, wound therapy
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
Sites / Locations
- St. Josef Hospital, Dep. Dermatology and Allergology, Ruhr University Bochum
Outcomes
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00349700
Brief Title
Wound Dressings Adapted to Wound Exudate and Bacterial Load in Therapy Resistant Large Sized Leg Ulcers
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 Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Ruhr University of Bochum
4. Oversight
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Ulcer
Keywords
healing, skin, infection, wound therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
139 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Compression: 2 weeks four layer bandages, then stockings
Intervention Type
Procedure
Intervention Name(s)
debridement
Intervention Type
Procedure
Intervention Name(s)
Actisorb plus (r) + Trionic(r)/ Allevyn (r)
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Altmeyer, Prof. Dr.
Organizational Affiliation
Ruhr University Bochum, Dep. Dermatology and Allergology
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Josef Hospital, Dep. Dermatology and Allergology, Ruhr University Bochum
City
Bochum
ZIP/Postal Code
44791
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Wound Dressings Adapted to Wound Exudate and Bacterial Load in Therapy Resistant Large Sized Leg Ulcers
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