Larval Debridement Therapy Versus Sharp Debridement to Remove Biofilm
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|ClinicalTrials.gov Identifier: NCT02294175|
Recruitment Status : Completed
First Posted : November 19, 2014
Last Update Posted : August 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lower Extremity or Diabetic Foot Ulcers Bacterial Infection||Device: Larval Debridement Therapy Procedure: Bedside Sharp Debridement||Not Applicable|
Drug resistant organisms and bacterial biofilm pose an increasing threat to the health of millions of individuals world-wide. These organisms are being identified with an alarming prevalence among persons with chronic wounds. The presence of necrotic tissue has been associated with the deterioration of open wounds and serves as a breeding ground and nutrient source for bacteria. The removal of necrotic tissue is widely accepted as required for optimal wound healing.
The primary purpose of this study is to assess the efficacy of larval debridement therapy (LDT) with bagged, sterilized, live, medicinal blow fly (Lucilia sericata) larvae (or " BioBags") versus bedside sharp debridement in removing harmful bacteria, biofilm and necrotic tissue from chronic wounds to promote wound healing. Characteristics associated with chronic wound environments will be evaluated through analysis of samples of tissue taken from wound beds before and after both types of debridement. One hundred and forty patients ≥ 21 years of age (and their caregivers and wound providers)with an open, full thickness wound which is healing by secondary intention (of greater than 8 weeks duration and requires debridement) will be invited to participate. This recruitment number accounts for estimated 10% attrition rate, so final sample number is anticipated to be 296 or 128 Veteran subjects (64 in each arm) and 128 caregivers, and 6 providers (and total of 34 subjects which may be lost to follow up). Samples of wound bed tissue and slough tissue (if present) will be collected on Days 0, 4 and 8 or prior to and after each larval debridement intervention or sharp debridement (control). Photos will be taken of the wound bed on Days 0, 4 and 8 or just prior to and after each debridement method. A randomized sampling procedure will place individuals into one of two groups: The intervention group will receive larval debridement therapy once every 4 days for 2 applications (with saline moistened gauze as cover dressing changed daily) and the control group will receive sharp debridement therapy every 7 days for 2 debridements (with wound gel dressing changed daily).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||RCT: Larval Debridement Therapy Versus Sharp Debridement to Remove Biofilm From Chronic Lower Extremity or Diabetic Foot Ulcers|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||March 24, 2018|
Active Comparator: Larval Debridement Therapy
Larval 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.
Device: Larval Debridement Therapy
small sterile mesh bags containing live maggots placed into an open chronic wound to remove necrotic tissue and bacterial biofilm
Active Comparator: Sharp Debridement Therapy
Bedside 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.
Procedure: Bedside Sharp Debridement
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
- quantity of bacterial biofilm in the wound [ Time Frame: 8 days ]colony forming units of bacteria in a biofilm formation in a chronic wound
- necrotic tissue in the wound [ Time Frame: 8 days ]visable amount of necrotic or non-viable tissue in the wound bed of a chronic wound
- wound healing biomarkers [ Time Frame: 8 days ]measurable amounts of specific biomarkers (MMPs, cytokines) in the wound bed
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02294175
|United States, Florida|
|North Florida Regional Medical Center|
|Gainesville, Florida, United States, 32605|
|North Florida / South Georgia Veterans Health System|
|Gainesville, Florida, United States, 32608|
|Principal Investigator:||Linda J Cowan, PhD||North Florida/South Georgia Veterans Health System|