Trial Outcomes & Findings for Larval Debridement Therapy Versus Sharp Debridement to Remove Biofilm (NCT NCT02294175)
NCT ID: NCT02294175
Last Updated: 2020-04-07
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
Day 0 (Baseline), Day 4, Day 8
Results posted on
2020-04-07
Participant Flow
Participant milestones
| Measure |
Larval Debridement Therapy (LDT) - Patients
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
|
Sharp Debridement Therapy (SDT) - Patients
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 Study
STARTED
|
23
|
22
|
|
Overall Study
COMPLETED
|
18
|
16
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
Larval Debridement Therapy (LDT) - Patients
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
|
Sharp Debridement Therapy (SDT) - Patients
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 Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
pt taking excluded medication
|
3
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
wound healed
|
0
|
2
|
Baseline Characteristics
Larval Debridement Therapy Versus Sharp Debridement to Remove Biofilm
Baseline characteristics by cohort
| Measure |
Larval Debridement Therapy
n=18 Participants
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
|
Sharp Debridement Therapy
n=16 Participants
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
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.9 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
64.9 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
65.4 years
STANDARD_DEVIATION 7.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not documented
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Current Smokers
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
History of wounds
History of diabetic lower extremity wounds
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
History of wounds
Venous leg ulcers
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
History of wounds
Other lower extremity wounds
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
History of wounds
None documented
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Marital/partner status
Married/partner
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Marital/partner status
Single
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Marital/partner status
Widow/Widower
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Marital/partner status
Declined to answer
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Suspected duration of wound at enrollment
Over 8 weeks unknown total duration
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Suspected duration of wound at enrollment
Over 8 weeks but under 6 months duration
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Suspected duration of wound at enrollment
Over 6 months but under 1 year duration
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Suspected duration of wound at enrollment
One year or longer duration
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Suspected duration of wound at enrollment
Not documented
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 (Baseline), Day 4, Day 8Population: Statistical analysis was performed on a subset of participants (n=32) due to missing data on one or more days of measurement.
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).
Outcome measures
| Measure |
Larval Debridement Therapy
n=17 Participants
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
|
Sharp Debridement Therapy
n=15 Participants
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 Bacteria Colony Forming Units (CFUs; Natural-log Transformed), With Tryptic Soy Agar (TSA) Plating
Day 0
|
9.6561 Natural Log Transformed Bacterial CFU
Standard Deviation 3.10402
|
9.6880 Natural Log Transformed Bacterial CFU
Standard Deviation 1.75013
|
|
Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed), With Tryptic Soy Agar (TSA) Plating
Day 4
|
11.9611 Natural Log Transformed Bacterial CFU
Standard Deviation 1.68800
|
9.1547 Natural Log Transformed Bacterial CFU
Standard Deviation 2.57417
|
|
Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed), With Tryptic Soy Agar (TSA) Plating
Day 8
|
11.4864 Natural Log Transformed Bacterial CFU
Standard Deviation 2.05378
|
10.4479 Natural Log Transformed Bacterial CFU
Standard Deviation 2.25869
|
PRIMARY outcome
Timeframe: Day 0 (Baseline), Day 4, Day 8Population: Statistical analysis was performed on a subset of participants (n=33) due to missing data on one or more days of measurement.
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).
Outcome measures
| Measure |
Larval Debridement Therapy
n=18 Participants
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
|
Sharp Debridement Therapy
n=15 Participants
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 Bacteria Colony Forming Units (CFUs; Natural-log Transformed), With MacConkey Agar Plating
Day 0
|
4.5512 Natural Log Transformed Bacterial CFU
Standard Deviation 4.32429
|
5.4009 Natural Log Transformed Bacterial CFU
Standard Deviation 4.76243
|
|
Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed), With MacConkey Agar Plating
Day 4
|
8.9408 Natural Log Transformed Bacterial CFU
Standard Deviation 3.64582
|
6.2482 Natural Log Transformed Bacterial CFU
Standard Deviation 4.32648
|
|
Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed), With MacConkey Agar Plating
Day 8
|
8.9198 Natural Log Transformed Bacterial CFU
Standard Deviation 4.33985
|
6.8660 Natural Log Transformed Bacterial CFU
Standard Deviation 4.80509
|
PRIMARY outcome
Timeframe: Day 0 (Baseline), Day 4, Day 8Population: Statistical analysis was performed on a subset of participants (n=33) due to missing data on one or more days of measurement.
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).
Outcome measures
| Measure |
Larval Debridement Therapy
n=18 Participants
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
|
Sharp Debridement Therapy
n=15 Participants
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 Bacteria Colony Forming Units (CFUs; Natural-log Transformed),With Phenylethyl Alcohol (PEA) Plating
Day 0
|
7.0633 Natural Log Transformed Bacterial CFU
Standard Deviation 4.45210
|
8.7514 Natural Log Transformed Bacterial CFU
Standard Deviation 1.56580
|
|
Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed),With Phenylethyl Alcohol (PEA) Plating
Day 4
|
9.8704 Natural Log Transformed Bacterial CFU
Standard Deviation 2.69279
|
8.5673 Natural Log Transformed Bacterial CFU
Standard Deviation 2.64319
|
|
Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed),With Phenylethyl Alcohol (PEA) Plating
Day 8
|
9.2877 Natural Log Transformed Bacterial CFU
Standard Deviation 2.71007
|
9.7341 Natural Log Transformed Bacterial CFU
Standard Deviation 2.52994
|
SECONDARY outcome
Timeframe: Day 8For 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).
Outcome measures
| Measure |
Larval Debridement Therapy
n=18 Participants
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
|
Sharp Debridement Therapy
n=16 Participants
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
|
|---|---|---|
|
Reviewer Assessment of Visible Wound Improvement
|
61.11 percentage of reviewers
Standard Deviation 39.503
|
71.88 percentage of reviewers
Standard Deviation 32.755
|
SECONDARY outcome
Timeframe: Day 0 (Baseline), Day 4, Day 8Population: Statistical analysis was performed on a subset of participants (n=20) due to missing data on one or more days of measurement.
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.
Outcome measures
| Measure |
Larval Debridement Therapy
n=11 Participants
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
|
Sharp Debridement Therapy
n=9 Participants
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
|
|---|---|---|
|
Inflammatory Biomarker MMP-9
Day 0
|
2.8538 Natural Log Transformed MMP-9 in pg/ml
Standard Deviation 0.83493
|
2.8965 Natural Log Transformed MMP-9 in pg/ml
Standard Deviation 0.87010
|
|
Inflammatory Biomarker MMP-9
Day 4
|
2.7847 Natural Log Transformed MMP-9 in pg/ml
Standard Deviation 0.76985
|
2.7260 Natural Log Transformed MMP-9 in pg/ml
Standard Deviation 0.71122
|
|
Inflammatory Biomarker MMP-9
Day 8
|
2.9985 Natural Log Transformed MMP-9 in pg/ml
Standard Deviation 0.63257
|
2.6861 Natural Log Transformed MMP-9 in pg/ml
Standard Deviation 0.84722
|
SECONDARY outcome
Timeframe: Day 0 (Baseline), Day 4, Day 8Population: Statistical analysis was performed on a subset of participants (n=27) due to missing data on one or more days of measurement.
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.
Outcome measures
| Measure |
Larval Debridement Therapy
n=15 Participants
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
|
Sharp Debridement Therapy
n=12 Participants
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
|
|---|---|---|
|
Inflammatory Biomarker IL6
Day 8
|
4.0069 Natural Log Transformed IL6 in ng/ml
Standard Deviation 1.37460
|
4.0096 Natural Log Transformed IL6 in ng/ml
Standard Deviation 1.68661
|
|
Inflammatory Biomarker IL6
Day 0
|
3.4889 Natural Log Transformed IL6 in ng/ml
Standard Deviation 1.29396
|
3.5748 Natural Log Transformed IL6 in ng/ml
Standard Deviation 1.94347
|
|
Inflammatory Biomarker IL6
Day 4
|
4.2287 Natural Log Transformed IL6 in ng/ml
Standard Deviation 1.65271
|
4.2233 Natural Log Transformed IL6 in ng/ml
Standard Deviation 1.18058
|
SECONDARY outcome
Timeframe: Day 8Population: Statistical analysis was performed on a subset of participants (n=30) due to missing data on one or more measures.
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).
Outcome measures
| Measure |
Larval Debridement Therapy
n=15 Participants
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
|
Sharp Debridement Therapy
n=15 Participants
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
|
|---|---|---|
|
Satisfaction With Debridement: Overall Satisfaction With Method, Day 8
|
7.27 score on a scale
Standard Deviation 3.642
|
7.13 score on a scale
Standard Deviation 3.642
|
SECONDARY outcome
Timeframe: Day 8Population: Statistical analysis was performed on a subset of participants (n=32) due to missing data on one or more measures.
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
Outcome measures
| Measure |
Larval Debridement Therapy
n=16 Participants
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
|
Sharp Debridement Therapy
n=16 Participants
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
|
|---|---|---|
|
Satisfaction: Aesthetic Unpleasantness of Debridement, Day 8
|
2.63 score on a scale
Standard Deviation 2.872
|
3.75 score on a scale
Standard Deviation 4.266
|
SECONDARY outcome
Timeframe: Day 8Population: Statistical analysis was performed on a subset of participants (n=31) due to missing data on one or more measures.
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).
Outcome measures
| Measure |
Larval Debridement Therapy
n=15 Participants
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
|
Sharp Debridement Therapy
n=16 Participants
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
|
|---|---|---|
|
Satisfaction: Difficulty of Use/Care, Day 8
|
1.60 score on a scale
Standard Deviation 2.530
|
1.88 score on a scale
Standard Deviation 3.243
|
SECONDARY outcome
Timeframe: Day 8Population: Statistical analysis was performed on a subset of participants (n=30) due to missing data on one or more measures.
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.
Outcome measures
| Measure |
Larval Debridement Therapy
n=14 Participants
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
|
Sharp Debridement Therapy
n=16 Participants
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
|
|---|---|---|
|
Satisfaction: Wound Pain, Day 8
|
4.14 DVPRS (Pain) Score
Standard Deviation 3.110
|
3.63 DVPRS (Pain) Score
Standard Deviation 3.284
|
Adverse Events
Larval Debridement Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Sharp Debridement Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Linda Cowan
James A. Haley Veterans Hospital and Clinics
Phone: 813-558-3932
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place