Treatment of Chronic Wound Biofilms

This study is not yet open for participant recruitment.
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

July 18, 2012
March 10, 2014
July 2014
December 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01646502 on ClinicalTrials.gov Archive Site
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.
Same as current
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.
Same as current
 
Treatment of Chronic Wound Biofilms
Treatment of Chronic Wound Staphylococcus Aureus Biofilms With Staphylococcus Epidermidis Esp Protein to Promote Healing

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.

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Wound
  • Venous Insufficiency
  • Biofilms
  • Biological: Esp protein
  • Other: Standard wound care
  • Experimental: Esp-supplemented standard wound care
    500 pmol Esp protein will be added to the standard wound care protocol.
    Intervention: 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.
    Intervention: Other: Standard wound care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
10
December 2015
December 2015   (final data collection date for primary outcome measure)

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)
Both
19 Years and older
No
Contact: Brian Kunimoto, MD 604-875-4747 briant_kunimoto@telus.net
Contact: Christina Scali, MD 604-603-9981 christina.scali@gmail.com
Canada
 
NCT01646502
H12-00862
No
University of British Columbia
University of British Columbia
Not Provided
Principal Investigator: Brian Kunimoto, MD University of British Columbia
University of British Columbia
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP