Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01646502
Study type Interventional
Source University of British Columbia
Contact
Status Withdrawn
Phase N/A
Start date July 2014
Completion date December 2015

See also
  Status Clinical Trial Phase
Completed NCT05507346 - A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema N/A
Completed NCT04469361 - The Effect of Training on Hemodynamic Factors in Ballet Dancer
Recruiting NCT05633277 - Outcomes of Sclerotherapy of the Ulcer Bed Compared to a Combination of Ablation and Injections N/A
Completed NCT03283800 - Copper Impact on Venous Insufficiency and Lipodermatosclerosis N/A
Terminated NCT03311269 - A Study Evaluating ClariVein With a Sclerosing Agent for the Treatment of Venous Insufficiency Phase 2
Withdrawn NCT01680809 - Compliance of Compression Therapy in Healed Venous Ulcerations N/A
Completed NCT00617825 - Feasibility Study of Cryotherapy for Chronic Venous Disorders N/A
Active, not recruiting NCT00270972 - The Evaluation of OrCel for the Treatment of Venous Ulcers N/A
Completed NCT01701661 - Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux N/A
Active, not recruiting NCT06369207 - Investigation of the Transmission Pathways of Reflux in Patients With Chronic Venous Insufficiency
Completed NCT04461132 - The Effect of Manual Lymphatic Drainage N/A
Recruiting NCT04546750 - Prospective Cohort Study for Varicose Veins Incidence and Natural Course
Not yet recruiting NCT03543007 - Evaluating the Safety and Efficacy of GrafixPLâ„¢PRIME for the Treatment of Chronic Venous Leg Ulcers N/A
Active, not recruiting NCT02397226 - Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery N/A
Not yet recruiting NCT01110512 - Comparative Efficacy of Two Preparations of the Association Diosmin (450 mg) + Hesperidin (50 mg) in the Treatment of Chronic Venous Insufficiency (CVI) Phase 3
Completed NCT00565604 - Safety and Efficacy of Endovenous Laser Ablation for the Resolution of Incompetent Perforator Veins N/A
Completed NCT01298908 - Comparison of Treatments in Venous Insufficiency N/A
Active, not recruiting NCT00841178 - Endovenous Laser Therapy (EVLT) for Sapheno-Popliteal Incompetence and Short Saphenous Vein (SSV) Reflux: A RCT N/A
Not yet recruiting NCT03652025 - The Effectiveness of Trans-catheter Foam Sclerotherapy of Pelvic and Atypical Lower Limb Varicosities N/A
Completed NCT03755180 - Exercise Training in Venous Insufficiency N/A