Treatment of Chronic Wound Biofilms

NCT01646502 | Withdrawn

• 1 other identifier: H12-00862
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic wounds cause significant morbidity and cost our healthcare system millions of dollars each year.Their healing is slowed by biofilms, communities of bacteria surrounded by a protective layer that stops the immune system and antibiotics from getting close enough to kill them. The investigators will develop a new strategy to destroy biofilms using a protein made from bacteria that live on our skin.The Staphylococcus epidermidis Esp protein will be used to destroy Staphylococcus aureus biofilms, the most common bacterium in chronic wounds. The investigators hypothesize that the use of the Esp protein will breakdown S. aureus biofilms, decrease bacterial colonization of chronic wounds and improve healing times.

Conditions

Chronic Wound; Venous Insufficiency; Biofilms

Keywords

chronic wound; treatment; biofilms; venous insufficiency; Esp

Outcome Measures

Primary Outcomes (1)

• rate of wound healing

  The rate of wound healing (% change in wound surface area) over each 6-week treatment period.

  6 weeks

Secondary Outcomes (1)

• A qualitative assessment of the healing process.

  1 week

Other Outcomes (1)

• Bacterial type and quantity.

  6 weeks

Study Arms (2)

Esp-supplemented standard wound care

EXPERIMENTAL

500 pmol Esp protein will be added to the standard wound care protocol.

Biological: Esp protein

Standard wound care

ACTIVE COMPARATOR

The standard treatment protocol established at the Vancouver Wound Healing Clinic is based on the "Best Clinical Practice Guidelines for Venous Leg Ulcers" from the Canadian Association of Wound Care.

Other: Standard wound care

Interventions

Esp protein BIOLOGICAL

Esp-supplemented standard wound care

Standard wound care OTHER

Standard wound care

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a leg ulcer with the ankle brachial pressure index (ABPI) equal or greater than 0.6;
• Have a wound that is 15 cm or less in diameter;
• Are 19 years or older;
• Have no known contraindication to the treatment products

You may not qualify if:

• Have a leg ulcer caused by pressure, diabetes, ischemia, inflammatory disorder, hematologic disorder or malignancy
• Have applied an antiseptic to the wound in the one week prior to recruitment
• Have received systemic or topical antibiotic therapy within 48 hours prior to recruitment
• Are being treated with systemic steroids (prednisone)

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Wound Healing Clinic,Vancouver General Hospital - Gordon and Leslie Diamond Health Care Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Venous Insufficiency

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Brian Kunimoto, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2012
• First Posted: July 20, 2012
• Study Start: July 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 7, 2014

Record last verified: 2014-10

Locations

CA (1)