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Larval Debridement Therapy Versus Sharp Debridement to Remove Biofilm

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02294175
Recruitment Status : Completed
First Posted : November 19, 2014
Results First Posted : April 7, 2020
Last Update Posted : April 7, 2020
Sponsor:
Collaborators:
North Florida/South Georgia Veterans Health System
Biomonde
Information provided by (Responsible Party):
North Florida Foundation for Research and Education

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lower Extremity or Diabetic Foot Ulcers
Bacterial Infection
Interventions Device: Larval Debridement Therapy
Procedure: Bedside Sharp Debridement
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Larval Debridement Therapy (LDT) - Patients Sharp Debridement Therapy (SDT) - Patients
Hide Arm/Group Description

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.

Larval Debridement Therapy: small sterile mesh bags containing live maggots placed into an open chronic wound to remove necrotic tissue and bacterial biofilm

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.

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

Period Title: Overall Study
Started 23 22
Completed 18 16
Not Completed 5 6
Reason Not Completed
Withdrawal by Subject             1             2
pt taking excluded medication             3             1
Protocol Violation             1             0
Lost to Follow-up             0             1
wound healed             0             2
Arm/Group Title Larval Debridement Therapy Sharp Debridement Therapy Total
Hide Arm/Group Description

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.

Larval Debridement Therapy: small sterile mesh bags containing live maggots placed into an open chronic wound to remove necrotic tissue and bacterial biofilm

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.

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

Total of all reporting groups
Overall Number of Baseline Participants 18 16 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 16 participants 34 participants
65.9  (8.5) 64.9  (6.6) 65.4  (7.89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
Female
2
  11.1%
3
  18.8%
5
  14.7%
Male
16
  88.9%
13
  81.3%
29
  85.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
Black/African American
3
  16.7%
4
  25.0%
7
  20.6%
Hispanic/Latino
0
   0.0%
1
   6.3%
1
   2.9%
White/Caucasian
11
  61.1%
11
  68.8%
22
  64.7%
Other
1
   5.6%
0
   0.0%
1
   2.9%
Not documented
3
  16.7%
0
   0.0%
3
   8.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 18 participants 16 participants 34 participants
18
 100.0%
16
 100.0%
34
 100.0%
Current Smokers  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
3
  16.7%
5
  31.3%
8
  23.5%
History of wounds  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
History of diabetic lower extremity wounds
10
  55.6%
11
  68.8%
21
  61.8%
Venous leg ulcers
4
  22.2%
3
  18.8%
7
  20.6%
Other lower extremity wounds
2
  11.1%
2
  12.5%
4
  11.8%
None documented
2
  11.1%
0
   0.0%
2
   5.9%
Marital/partner status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
Married/partner
7
  38.9%
7
  43.8%
14
  41.2%
Single
8
  44.4%
9
  56.3%
17
  50.0%
Widow/Widower
1
   5.6%
0
   0.0%
1
   2.9%
Declined to answer
2
  11.1%
0
   0.0%
2
   5.9%
Suspected duration of wound at enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
Over 8 weeks unknown total duration
2
  11.1%
1
   6.3%
3
   8.8%
Over 8 weeks but under 6 months duration
2
  11.1%
5
  31.3%
7
  20.6%
Over 6 months but under 1 year duration
7
  38.9%
2
  12.5%
9
  26.5%
One year or longer duration
5
  27.8%
8
  50.0%
13
  38.2%
Not documented
2
  11.1%
0
   0.0%
2
   5.9%
1.Primary Outcome
Title Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed), With Tryptic Soy Agar (TSA) Plating
Hide Description 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).
Time Frame Day 0 (Baseline), Day 4, Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Statistical analysis was performed on a subset of participants (n=32) due to missing data on one or more days of measurement.
Arm/Group Title Larval Debridement Therapy Sharp Debridement Therapy
Hide Arm/Group Description:

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.

Larval Debridement Therapy: small sterile mesh bags containing live maggots placed into an open chronic wound to remove necrotic tissue and bacterial biofilm

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.

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

Overall Number of Participants Analyzed 17 15
Mean (Standard Deviation)
Unit of Measure: Natural Log Transformed Bacterial CFU
Day 0 9.6561  (3.10402) 9.6880  (1.75013)
Day 4 11.9611  (1.68800) 9.1547  (2.57417)
Day 8 11.4864  (2.05378) 10.4479  (2.25869)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Larval Debridement Therapy, Sharp Debridement Therapy
Comments Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether the reduction of bacterial CFUs over time varies according to treatment arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .029
Comments Repeated Measures ANOVA. The interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).
Method Repeated Measures ANOVA
Comments Greenhouse-Geisser corrections were applied to the F test degrees of freedom due to violation of the sphericity assumption (p<.05 for Mauchly's W).
2.Primary Outcome
Title Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed), With MacConkey Agar Plating
Hide Description 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).
Time Frame Day 0 (Baseline), Day 4, Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Statistical analysis was performed on a subset of participants (n=33) due to missing data on one or more days of measurement.
Arm/Group Title Larval Debridement Therapy Sharp Debridement Therapy
Hide Arm/Group Description:

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.

Larval Debridement Therapy: small sterile mesh bags containing live maggots placed into an open chronic wound to remove necrotic tissue and bacterial biofilm

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.

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

Overall Number of Participants Analyzed 18 15
Mean (Standard Deviation)
Unit of Measure: Natural Log Transformed Bacterial CFU
Day 0 4.5512  (4.32429) 5.4009  (4.76243)
Day 4 8.9408  (3.64582) 6.2482  (4.32648)
Day 8 8.9198  (4.33985) 6.8660  (4.80509)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Larval Debridement Therapy, Sharp Debridement Therapy
Comments Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether the reduction of bacterial CFUs over time varies according to treatment arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .037
Comments Repeated Measures ANOVA. This interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).
Method Repeated Measures ANOVA
Comments Greenhouse-Geisser corrections were applied to the F test degrees of freedom due to violation of the sphericity assumption (p<.05 for Mauchly's W).
3.Primary Outcome
Title Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed),With Phenylethyl Alcohol (PEA) Plating
Hide Description 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).
Time Frame Day 0 (Baseline), Day 4, Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Statistical analysis was performed on a subset of participants (n=33) due to missing data on one or more days of measurement.
Arm/Group Title Larval Debridement Therapy Sharp Debridement Therapy
Hide Arm/Group Description:

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.

Larval Debridement Therapy: small sterile mesh bags containing live maggots placed into an open chronic wound to remove necrotic tissue and bacterial biofilm

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.

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

Overall Number of Participants Analyzed 18 15
Mean (Standard Deviation)
Unit of Measure: Natural Log Transformed Bacterial CFU
Day 0 7.0633  (4.45210) 8.7514  (1.56580)
Day 4 9.8704  (2.69279) 8.5673  (2.64319)
Day 8 9.2877  (2.71007) 9.7341  (2.52994)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Larval Debridement Therapy, Sharp Debridement Therapy
Comments Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether the reduction of bacterial CFUs over time varies according to treatment arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .012
Comments Repeated Measures ANOVA. This interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).
Method Repeated Measures ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Reviewer Assessment of Visible Wound Improvement
Hide Description For each patient, wound photos were taken at days 0, 4, and 8 and given to wound specialists. Wound specialists reviewed photos to assess whether there was visible reduction in amount of necrotic or non-viable tissue remaining in the wound bed at day 8--i.e., whether the wound appeared to be improved (yes vs. no). The percentage of reviewers (out of 4) who responded "yes" that the wound appeared improved was calculated for each patient. Thus, each patient received a score for percentage of reviewers who saw visual improvement; the means and standard deviations for these percentages were compared between LDT and SDT groups. Higher scores correspond to better outcomes (higher proportion of reviewers who responded that wounds appeared visibly improved).
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Larval Debridement Therapy Sharp Debridement Therapy
Hide Arm/Group Description:

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.

Larval Debridement Therapy: small sterile mesh bags containing live maggots placed into an open chronic wound to remove necrotic tissue and bacterial biofilm

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.

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

Overall Number of Participants Analyzed 18 16
Mean (Standard Deviation)
Unit of Measure: percentage of reviewers
61.11  (39.503) 71.88  (32.755)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Larval Debridement Therapy, Sharp Debridement Therapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .397
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Inflammatory Biomarker MMP-9
Hide Description Using Enzyme Linked Immunosprbent Assay (ELISA), the levels of active Matrix Metalloproteinase type 9 (MMP-9) was calculated and expressed as pg/ml of wound fluid and pg/mg protein. Raw outcomes were natural-log transformed due to skewed distribution. Higher scores indicate worse outcomes.
Time Frame Day 0 (Baseline), Day 4, Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Statistical analysis was performed on a subset of participants (n=20) due to missing data on one or more days of measurement.
Arm/Group Title Larval Debridement Therapy Sharp Debridement Therapy
Hide Arm/Group Description:

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.

Larval Debridement Therapy: small sterile mesh bags containing live maggots placed into an open chronic wound to remove necrotic tissue and bacterial biofilm

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.

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

Overall Number of Participants Analyzed 11 9
Mean (Standard Deviation)
Unit of Measure: Natural Log Transformed MMP-9 in pg/ml
Day 0 2.8538  (0.83493) 2.8965  (0.87010)
Day 4 2.7847  (0.76985) 2.7260  (0.71122)
Day 8 2.9985  (0.63257) 2.6861  (0.84722)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Larval Debridement Therapy, Sharp Debridement Therapy
Comments Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether change in MMP-9 over time varies according to treatment arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .661
Comments Repeated Measures ANOVA. The interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).
Method Repeated Measures ANOVA
Comments [Not Specified]
6.Secondary Outcome
Title Inflammatory Biomarker IL6
Hide Description The levels of active IL6 was calculated using Enzyme Linked Immunosprbent Assay (ELISA) and reported in ng/ml. Raw outcomes were natural-log transformed due to skewed distribution. Higher scores indicate worse outcomes.
Time Frame Day 0 (Baseline), Day 4, Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Statistical analysis was performed on a subset of participants (n=27) due to missing data on one or more days of measurement.
Arm/Group Title Larval Debridement Therapy Sharp Debridement Therapy
Hide Arm/Group Description:

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.

Larval Debridement Therapy: small sterile mesh bags containing live maggots placed into an open chronic wound to remove necrotic tissue and bacterial biofilm

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.

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

Overall Number of Participants Analyzed 15 12
Mean (Standard Deviation)
Unit of Measure: Natural Log Transformed IL6 in ng/ml
Day 0 3.4889  (1.29396) 3.5748  (1.94347)
Day 4 4.2287  (1.65271) 4.2233  (1.18058)
Day 8 4.0069  (1.37460) 4.0096  (1.68661)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Larval Debridement Therapy, Sharp Debridement Therapy
Comments Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether change in IL6 over time varies according to treatment arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .979
Comments Repeated Measures ANOVA. The interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).
Method Repeated Measures ANOVA
Comments [Not Specified]
7.Secondary Outcome
Title Satisfaction With Debridement: Overall Satisfaction With Method, Day 8
Hide Description Satisfaction (Overall) item score. This item is from a Satisfaction with Debridement survey, designed to measure satisfaction with debridement method, aesthetic questions regarding debridement, ease of use/care, and wound pain. Individual item scores range from 0 to 10, with higher scores indicating better outcomes (higher overall satisfaction).
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Statistical analysis was performed on a subset of participants (n=30) due to missing data on one or more measures.
Arm/Group Title Larval Debridement Therapy Sharp Debridement Therapy
Hide Arm/Group Description:

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.

Larval Debridement Therapy: small sterile mesh bags containing live maggots placed into an open chronic wound to remove necrotic tissue and bacterial biofilm

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.

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

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: score on a scale
7.27  (3.642) 7.13  (3.642)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Larval Debridement Therapy, Sharp Debridement Therapy
Comments Kolmogorov-Smirnov Z test was used as a non-parametric test to compare rank scores between treatment arms (similar to Mann-Whitney, but potentially more powerful).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .999
Comments [Not Specified]
Method Kolmogorov-Smirnov Z
Comments [Not Specified]
8.Secondary Outcome
Title Satisfaction: Aesthetic Unpleasantness of Debridement, Day 8
Hide Description Survey item score for Aesthetic Unpleasantness of debridement. This item is from a Satisfaction with Debridement survey. Individual item scores range from 0 to 10, with higher scores on the aesthetic unpleasantness item indicating worse outcomes
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Statistical analysis was performed on a subset of participants (n=32) due to missing data on one or more measures.
Arm/Group Title Larval Debridement Therapy Sharp Debridement Therapy
Hide Arm/Group Description:

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.

Larval Debridement Therapy: small sterile mesh bags containing live maggots placed into an open chronic wound to remove necrotic tissue and bacterial biofilm

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.

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

Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.63  (2.872) 3.75  (4.266)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Larval Debridement Therapy, Sharp Debridement Therapy
Comments Kolmogorov-Smirnov Z test was used as a non-parametric test to compare rank scores between treatment arms (similar to Mann-Whitney, but potentially more powerful).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .415
Comments [Not Specified]
Method Kolmogorov-Smirnov Z
Comments [Not Specified]
9.Secondary Outcome
Title Satisfaction: Difficulty of Use/Care, Day 8
Hide Description Survey item score for Difficulty of Use/Care of debridement. This item is from a Satisfaction with Debridement survey. Individual item scores range from 0 to 10, with higher scores on the difficulty item indicating worse outcome (higher difficulty of use/care for debridement method).
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Statistical analysis was performed on a subset of participants (n=31) due to missing data on one or more measures.
Arm/Group Title Larval Debridement Therapy Sharp Debridement Therapy
Hide Arm/Group Description:

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.

Larval Debridement Therapy: small sterile mesh bags containing live maggots placed into an open chronic wound to remove necrotic tissue and bacterial biofilm

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.

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

Overall Number of Participants Analyzed 15 16
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.60  (2.530) 1.88  (3.243)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Larval Debridement Therapy, Sharp Debridement Therapy
Comments Kolmogorov-Smirnov Z test was used as a non-parametric test to compare rank scores between treatment arms (similar to Mann-Whitney, but potentially more powerful).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .993
Comments [Not Specified]
Method Kolmogorov-Smirnov Z
Comments [Not Specified]
10.Secondary Outcome
Title Satisfaction: Wound Pain, Day 8
Hide Description Satisfaction survey to measure satisfaction with debridement method, aesthetic questions regarding debridement, ease of use/care, and wound pain. Pain was measured using the Defense and Veterans Pain Rating Scale (DVPRS). Individual item scores range from 0 to 10, with higher scores on the DVPRS indicating higher pain and worse outcomes.
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Statistical analysis was performed on a subset of participants (n=30) due to missing data on one or more measures.
Arm/Group Title Larval Debridement Therapy Sharp Debridement Therapy
Hide Arm/Group Description:

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.

Larval Debridement Therapy: small sterile mesh bags containing live maggots placed into an open chronic wound to remove necrotic tissue and bacterial biofilm

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.

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

Overall Number of Participants Analyzed 14 16
Mean (Standard Deviation)
Unit of Measure: DVPRS (Pain) Score
4.14  (3.110) 3.63  (3.284)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Larval Debridement Therapy, Sharp Debridement Therapy
Comments Kolmogorov-Smirnov Z test was used as a non-parametric test to compare rank scores between treatment arms (similar to Mann-Whitney, but potentially more powerful).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .990
Comments [Not Specified]
Method Kolmogorov-Smirnov Z
Comments [Not Specified]
Time Frame period of time over which adverse event data were collected was 3 years (11/25/2014 to 11/25/2017).
Adverse Event Reporting Description definitions were not different, any adverse event reported by participant, clinician, or study team were recorded and reported to IRB as per regulatory protocol
 
Arm/Group Title Larval Debridement Therapy Sharp Debridement Therapy
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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.

Larval Debridement Therapy: small sterile mesh bags containing live maggots placed into an open chronic wound to remove necrotic tissue and bacterial biofilm

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.

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

All-Cause Mortality
Larval Debridement Therapy Sharp Debridement Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   1/18 (5.56%)   1/16 (6.25%) 
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Larval Debridement Therapy Sharp Debridement Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/16 (0.00%) 
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Frequency Threshold for Reporting Other Adverse Events 0%
Larval Debridement Therapy Sharp Debridement Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/16 (0.00%) 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Dr. Linda Cowan
Organization: James A. Haley Veterans Hospital and Clinics
Phone: 813-558-3932
EMail: linda.cowan@va.gov
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Responsible Party: North Florida Foundation for Research and Education
ClinicalTrials.gov Identifier: NCT02294175    
Other Study ID Numbers: 201400590
First Submitted: November 17, 2014
First Posted: November 19, 2014
Results First Submitted: November 26, 2019
Results First Posted: April 7, 2020
Last Update Posted: April 7, 2020