Larval Debridement Therapy Versus Sharp Debridement to Remove Biofilm
RCT: Larval Debridement Therapy Versus Sharp Debridement to Remove Biofilm From Chronic Lower Extremity or Diabetic Foot Ulcers
1 other identifier
interventional
45
1 country
2
Brief Summary
This is a prospective study of Veterans with chronic lower extremity or diabetic foot ulcers who will be randomized to either a Larval Debridement Therapy group (Biobags every 4 days x 2 applications) or a Sharp Debridement Therapy group (standard or control weekly x 2) during an 8 day study period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2015
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2014
CompletedFirst Posted
Study publicly available on registry
November 19, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 24, 2018
CompletedResults Posted
Study results publicly available
April 7, 2020
CompletedApril 7, 2020
March 1, 2020
2.9 years
November 17, 2014
November 26, 2019
March 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed), With Tryptic Soy Agar (TSA) Plating
Differences in total bacterial colony forming units (CFUs) between LDT and SDT arms at Day 0, with Tryptic Soy Agar (TSA) plating. Raw outcomes were natural-log transformed due to skewed distribution. Higher scores correspond to a greater number of bacterial CFUs (i.e., worse outcome).
Day 0 (Baseline), Day 4, Day 8
Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed), With MacConkey Agar Plating
Differences in total bacterial colony forming units (CFUs) between LDT and SDT arms at Day 0, with MacConkey Agar plating. Raw outcomes were natural-log transformed due to skewed distribution. Higher scores correspond to a greater number of bacterial CFUs (i.e., worse outcome).
Day 0 (Baseline), Day 4, Day 8
Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed),With Phenylethyl Alcohol (PEA) Plating
Differences in total bacterial colony forming units (CFUs) between LDT and SDT arms at Day 0, with Phenylethyl Alcohol (PEA) plating. Raw outcomes were natural-log transformed due to skewed distribution. Higher scores correspond to a greater number of bacterial CFUs (i.e., worse outcome).
Day 0 (Baseline), Day 4, Day 8
Secondary Outcomes (7)
Reviewer Assessment of Visible Wound Improvement
Day 8
Inflammatory Biomarker MMP-9
Day 0 (Baseline), Day 4, Day 8
Inflammatory Biomarker IL6
Day 0 (Baseline), Day 4, Day 8
Satisfaction With Debridement: Overall Satisfaction With Method, Day 8
Day 8
Satisfaction: Aesthetic Unpleasantness of Debridement, Day 8
Day 8
- +2 more secondary outcomes
Study Arms (2)
Larval Debridement Therapy
ACTIVE COMPARATORLarval debridement therapy intervention (Biobags) filled with sterile green bottle fly maggots (larvae) placed in open, chronic lower extremity or diabetic foot ulcer once every 4 days for total of 2 applications over the 8 day study period.
Sharp Debridement Therapy
ACTIVE COMPARATORBedside sharp debridement therapy as a comparator performed by wound care clinician once every 7 days in a chronic lower extremity or diabetic foot ulcer for a total of 2 sharp debridements over the 8 day study period.
Interventions
small sterile mesh bags containing live maggots placed into an open chronic wound to remove necrotic tissue and bacterial biofilm
The use of a sharp clinical instrument (currette, scalpel, scissors, forceps) by a qualified clinician to remove necrotic tissue and bacterial biofilm from an open chronic wound
Eligibility Criteria
You may qualify if:
- Veterans over 21 years of age
- with chronic lower extremity or diabetic foot ulcers (wound duration over 8 weeks)
- who at the clinician's judgment requires wound debridement (25% or more of wound bed covered with non-viable tissue)
- wound size 1.5 cm (roughly the size of a quarter) or larger in diameter
You may not qualify if:
- Cognitive impairment that would interfere with patient signing own Informed Consent
- Veterans on active anticoagulant therapy with most recent (within last week) PT/INR (international normalized ratio of prothrombin time) \> 3.0, or other significant bleeding risk
- Active immune suppression just prior to or during study (on systemic corticosteroids\* within 7 days prior, or chemotherapy for cancer or RA treatment within 4 weeks prior to study, or with diagnosis of HIV/AIDS) - \*Nasal steroid sprays will not be excluded
- Other possible reasons participants could be removed from this study include: transfers to other non-VA facilities, participant is unable to tolerate tissue sampling even with local anesthesia, and/or inability to comply with scheduled research visits. Furthermore, if the participant has significant wound healing so that sampling is not possible after the initial sampling, they will be removed from the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- North Florida Foundation for Research and Educationlead
- North Florida/South Georgia Veterans Health Systemcollaborator
- Biomondecollaborator
Study Sites (2)
North Florida Regional Medical Center
Gainesville, Florida, 32605, United States
North Florida / South Georgia Veterans Health System
Gainesville, Florida, 32608, United States
Related Publications (1)
Sen CK, Roy S, Mathew-Steiner SS, Gordillo GM. Biofilm Management in Wound Care. Plast Reconstr Surg. 2021 Aug 1;148(2):275e-288e. doi: 10.1097/PRS.0000000000008142.
PMID: 34398099DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This study was underpowered to observe significant difference between SDT and LDT groups. Aversion to LDT we anticipated in subjects, caregivers, and clinicians were not encountered. Almost all subjects in SDT group elected to try LDT after study.
Results Point of Contact
- Title
- Dr. Linda Cowan
- Organization
- James A. Haley Veterans Hospital and Clinics
Study Officials
- PRINCIPAL INVESTIGATOR
Linda J Cowan, PhD
North Florida/South Georgia Veterans Health System
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2014
First Posted
November 19, 2014
Study Start
January 1, 2015
Primary Completion
December 1, 2017
Study Completion
March 24, 2018
Last Updated
April 7, 2020
Results First Posted
April 7, 2020
Record last verified: 2020-03