NCT00203489

Brief Summary

The purpose of this study is to determine if a new antimicrobial gauze dressing is better than the current method of dressing open wounds with plain sterile gauze. It is hoped that the antimicrobial gauze will reduce the number of germs in the open wound and even improve the rate of healing.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

November 19, 2007

Status Verified

November 1, 2007

First QC Date

September 12, 2005

Last Update Submit

November 16, 2007

Conditions

Wounds

Outcome Measures

Primary Outcomes (1)

  • Rate of chronic wound colonization with resistant/prevalent microorganisms.

Secondary Outcomes (1)

  • Rate of wound surface area healing over time; Antibiotic utilization.

Interventions

KERLIX A.M.D. GauzeDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The subject is receiving care at the study wound care clinics.
  • The subject is 18 years of age or older.
  • The subject or authorized representative has signed the Informed Consent form.
  • The subject has a chronic wound as a result of pressure ulceration (grade III and IV ulcers only), underlying vascular disease ("leg ulcer"), diabetes mellitus (grade 2 and 3 ulcers only), or recent surgery.

You may not qualify if:

  • The subject has stage I and II pressure ulceration.
  • The subject has a superficial (grade 0 or 1) or limb-threatening diabetic foot ulceration (grade 4 or 5).
  • The subject has a leg ulcer related to carcinoma.
  • The subject is scheduled to go for amputation or surgical flap procedure as a result of an open wound.
  • Subject is scheduled to receive a V.A.C.® (Vacuum Assisted Closure) Dressing \[V.A.C.® (Vacuum Assisted Closure) Dressing KCI, Kinetic Concepts, Inc., San Antonio, TX\].
  • The subject has extensive burns or another acute diffuse skin condition (Stevens-Johnson Syndrome).
  • The subject has a history of hypersensitivity to Chlorhexidine Gluconate (CHG) or Polyhexamethylene Biguanide (PHMB).
  • The subject has severe systemic infection characterized by the systemic inflammatory response syndrome.
  • The subject has taken part in a wound healing study within the past month.
  • The subject has suspected or confirmed underlying osteomyelitis contiguous to the ulcer and is not receiving systemic antimicrobial therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook & Women's College Health Sciences Centre

Toronto, Ontario, M5S 1B2, Canada

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Tonya M. Eggleston, RN, MPH

    Tyco Healthcare/Kendall

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

June 1, 2005

Study Completion

August 1, 2007

Last Updated

November 19, 2007

Record last verified: 2007-11

Locations

CA(1)