A Clinical Study of An Antimicrobial Gauze Dressing

Wounds Clinical Trial

Official title:

A Prospective Randomized Double-Blind Trial of a Polyhexamethylene Biguanide (PHMB) Impregnated Gauze Dressing for the Prevention of Chronic Wound Colonization With Resistant and Prevalent Microorganisms

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00203489
• Other study ID #: Study Protocol 331.18
• Status: Terminated
• Phase: N/A
• First received: September 12, 2005
• Last updated: November 16, 2007
• Start date: June 2005
• Est. completion date: August 2007

Study information

• Verified date: November 2007
• Source: Tyco Healthcare Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Description:

Without adequate debridement, chronically infected wounds persist and form a nidus for the acquisition of antimicrobial-resistant microorganisms. Multiple studies state that patients with chronic wounds were colonized with one or more resistant bacteria, and that the presence of a chronic wound or decubitus ulcer was associated with a statistically increased likelihood of colonization with methicillin-resistant Staphylococcus aureus (MRSA), ciprofloxacin-resistant gram-negative bacilli (GNB),colonization and infection with ceftazidime-resistant Escherichia coli and Klebsiella pneumoniae.

Recently, a newly formulated gauze dressing impregnated with an antiseptic agent has become available. This product offers the promise of a combined benefit of wet-to-dry mechanical debridement, while providing high local concentrations of a potent antiseptic to prevent colonization and infection of the wound by resistant microorganisms, potentially enhancing wound healing.

This study proposes to determine if use of the antimicrobial gauze in routine wound care results in a lower rate of chronic wound colonization with resistant microorganisms and prevalent microorganisms as compared to standard wound care (with non-antimicrobial gauze).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The subject is receiving care at the study wound care clinics.

2. The subject is 18 years of age or older.

3. The subject or authorized representative has signed the Informed Consent form.

4. 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.

Exclusion Criteria:

1. The subject has a chronic ulcer that is a result of a condition other than that defined in the inclusion criteria.

2. The subject has stage I and II pressure ulceration.

3. The subject has a superficial (grade 0 or 1) or limb-threatening diabetic foot ulceration (grade 4 or 5).

4. The subject has a leg ulcer related to carcinoma.

5. The subject is scheduled to go for amputation or surgical flap procedure as a result of an open wound.

6. 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].

7. The subject has extensive burns or another acute diffuse skin condition (Stevens-Johnson Syndrome).

8. The subject has a history of hypersensitivity to Chlorhexidine Gluconate (CHG) or Polyhexamethylene Biguanide (PHMB).

9. The subject has severe systemic infection characterized by the systemic inflammatory response syndrome.

10. The subject has taken part in a wound healing study within the past month.

11. The subject has suspected or confirmed underlying osteomyelitis contiguous to the ulcer and is not receiving systemic antimicrobial therapy.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Wounds

Intervention

Device:
• KERLIX A.M.D. Gauze

Locations

Country	Name	City	State
Canada	Sunnybrook & Women's College Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Tyco Healthcare Group

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of chronic wound colonization with resistant/prevalent microorganisms.
Secondary	Rate of wound surface area healing over time; Antibiotic utilization.