Treatment of Chronic Wound Biofilms

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01646502
First received: July 18, 2012
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Chronic Wound
Venous Insufficiency
Biofilms
Biological: Esp protein
Other: Standard wound care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Chronic Wound Staphylococcus Aureus Biofilms With Staphylococcus Epidermidis Esp Protein to Promote Healing

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • rate of wound healing [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The rate of wound healing (% change in wound surface area) over each 6-week treatment period.


Secondary Outcome Measures:
  • A qualitative assessment of the healing process. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    A physician or nurse will record a visual assessment of the chronic wound in order to obtain a qualitative wound score.


Other Outcome Measures:
  • Bacterial type and quantity. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    This will be determined by wound biopsy performed at baseline and at weeks 6 and 12.


Estimated Enrollment: 10
Study Start Date: July 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Esp-supplemented standard wound care
500 pmol Esp protein will be added to the standard wound care protocol.
Biological: Esp protein
Active Comparator: Standard wound care
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

Detailed Description:

Chronic wounds lead to significant patient morbidity and mortality, and its treatment is associated with a global economic burden of $13-$15 billion annually. In Canada, the average cost of three months of community care for a chronic wound is $ 27,600.00. One of the major complications associated with chronic wounds is colonization with a Staphylococcus aureus (S. aureus) biofilm. These bacterial biofilms delay re-epithelialization and prevent wound healing. Standard treatment of chronic wound biofilms includes aggressive debridement as well as the addition of anti-biofilm agents such as antimicrobials. Since antimicrobial resistance is becoming a serious problem, finding alternatives is essential.

Staphylococcus epidermidis (S. epidermidis) JK16 cells, their culture supernatants and a serine protease (Esp) in the culture supernatants have been shown to inhibit the formation of and destroy preexisting S. aureus biofilms. The investigators hypothesize that the use of S. epidermidis JK16, culture supernatants or purified Esp protein in the standard wound care protocol will breakdown S. aureus biofilms, decrease bacterial colonization of chronic wounds and improve healing times. The investigators will employ a two-way cross over study where participants will receive standard wound care or S. epidermidis JK16 Esp supplemented treatment for the first 6 weeks followed by cross over for a further 6 weeks. These patients will be recruited from the Wound Healing Clinic at Vancouver General Hospital. Standard wound care will be provided in accordance with established protocols based on "Best Clinical Practice Guidelines for Venous Leg Ulcers" from the Canadian Association of Wound Care. For the S. epidermidis JK16 Esp supplemented treatment arm, the investigators will produce purified Esp and impregnate wound dressings with this protein. After 6 weeks, participants will be crossed over to the corresponding treatment arm.

Our primary outcome measure will be healing rate as calculated for each 6 week standard or experimental treatment periods. The investigators will employ standardized photography and wound image analysis software to calculate the healing rate. Other outcome measures will include visual detection and qualitative assessment of biofilms as determined by trained nurses and/or physicians. Finally, bacterial type and quantity will be determined by wound biopsy. Outcome measures for standard treatment arms will be compared with results from S. epidermidis JK16 Esp supplemented treatment arms. Objectives of this pilot study include:

  1. To assess the feasibility of conducting a more definitive trial to examine the efficacy of S. epidermidis Esp protein from strain JK16 in healing chronic wounds
  2. To perform a pilot study using a cross-over design with the purified S. epidermidis Esp protein from strain JK16 in comparison to standard therapy
  3. To demonstrate that the intervention is acceptable to participants
  4. To demonstrate the safety of the intervention
  5. To explore the biologic activity of S. epidermidis Esp protein from strain JK16 on wound biofilms and healing times
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Have a leg ulcer caused by pressure, diabetes, ischemia, inflammatory disorder, hematologic disorder or malignancy
  2. Have applied an antiseptic to the wound in the one week prior to recruitment
  3. Have received systemic or topical antibiotic therapy within 48 hours prior to recruitment
  4. Are being treated with systemic steroids (prednisone)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01646502

Contacts
Contact: Brian Kunimoto, MD 604-875-4747 briant_kunimoto@telus.net
Contact: Christina Scali, MD 604-603-9981 christina.scali@gmail.com

Locations
Canada, British Columbia
Wound Healing Clinic,Vancouver General Hospital - Gordon and Leslie Diamond Health Care Centre Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Brian Kunimoto, MD    604-875-4747      
Principal Investigator: Brian Kunimoto, MD         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Brian Kunimoto, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01646502     History of Changes
Other Study ID Numbers: H12-00862
Study First Received: July 18, 2012
Last Updated: March 10, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
chronic wound
treatment
biofilms
venous insufficiency
Esp

Additional relevant MeSH terms:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014