Evaluate the Impact of Drawtex in Venous Leg Ulcers

Moderatley to Highly Exuding Venous Leg Ulcers Clinical Trial

Official title:

Clinical Study to Comparatively Evaluate the Impact of Drawtex Wound Dressing Against Wound Bioburden in Moderately to Highly Exuding Venous Leg Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01319123
• Other study ID #: 56-RW-019
• Status: Completed
• Phase: N/A
• First received: March 10, 2011
• Last updated: October 29, 2012
• Start date: October 2010
• Est. completion date: August 2011

Study information

• Verified date: October 2012
• Source: Southwest Regional Wound Care Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a clinical study to comparatively evaluate the impact of Drawtex wound dressing against wound bioburden in moderately to highly exuding venous leg ulcers.

Description:

Each subject is expected to participate in this study for a period of four weeks or until reepithelialization, whichever occurs first. Subjects may participate for an additional period of four weeks or until reepithelialization, whichever occurs first: this it to be decided by the investigator and will be determined by the accessibility of the patient (physical location) and the suitability of the wound to further treatment. The maximum time period for the study is 8 weeks. The minimum time frame is at least 4 week, or until reepithelialization occurs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject > 18 years.

• Subject is attending weekly office visits at SW Wound Care Center as an out-patient.

• Subject has a moderately to highly exudative venous leg ulcer that would be indicated for treatment with Drawtex

• Subject or is informed about the trial, understands its nature of the study and provides written informed consent prior to study enrollment.

• Subject is willing and able to comply with all specified care and visit requirements

Exclusion Criteria:

• Subject has a lesion that does not meet the inclusion criteria.

• Subject refuses to participate in the study.

• Subject already participates in the this study with one wound (only one wound per subject is allowed)

• Subject has known sensitivity to the trial product or any of its compounds.

• Subject is expected to be non-compliant.

• Subject's lesion is a primary skin cancer.

• Subject's lesion is the manifestation of a metastasis.

• Subject is pregnant.

Related Conditions & MeSH terms

• Leg Ulcer
• Moderatley to Highly Exuding Venous Leg Ulcers
• Ulcer
• Varicose Ulcer

Intervention

Device:
• Drawtex dressing
The dressing is indicated for moderately to heavily exuding wounds such as venous leg ulcers

Locations

Country	Name	City	State
United States	Southwest Regional Wound Care Center	Lubbock	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Regional Wound Care Center	Beier Drawtex Healthcare, (PTY). Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the impact of Drawtex on wound surface bioburden.	The dressing is indicated for moderately to heavily exuding wounds such as venous leg ulcers.• The safety of Drawtex will be measured by the number and type of any adverse events. Patient's tolerance and acceptance of the different dressings	2 years
Secondary	Tolerance	To further investigate whether Drawtex; Will have an overall benefit on the wound healing process.; Patient's tolerance and acceptance of the dressings. The overall effect on wound healing, as expressed by percentages of necrosis, slough, granulation and/or epithelium at the wound surface.; Condition of periwound skin; Mobility restrictions, related to the dressing; The number of dressings per dressing change, the number of dressing changes and the amount of nursing time involved	2 years