Bacterial Infection, Lower Extremity or Diabetic Foot Ulcers
Conditions
Keywords
larva, debridement, lower extremity or diabetic foot ulcer, biofilm, infection, chronic wound
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.
Detailed description
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).
Interventions
DEVICELarval Debridement Therapy
small sterile mesh bags containing live maggots placed into an open chronic wound to remove necrotic tissue and bacterial biofilm
PROCEDUREBedside 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
Sponsors
North Florida/South Georgia Veterans Health System
Biomonde
North Florida Foundation for Research and Education
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Active systemic antibiotics is an exclusion * Absent dorsalis pedis pulses and Ankle Brachial Index (ABI) \< 0.5 is an exclusion (indicates critical limb ischemia). * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed), With Tryptic Soy Agar (TSA) Plating | Day 0 (Baseline), Day 4, Day 8 | 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). |
| Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed), With MacConkey Agar Plating | Day 0 (Baseline), Day 4, Day 8 | 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). |
| Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed),With Phenylethyl Alcohol (PEA) Plating | Day 0 (Baseline), Day 4, Day 8 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction With Debridement: Overall Satisfaction With Method, Day 8 | Day 8 | 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). |
| Satisfaction: Aesthetic Unpleasantness of Debridement, Day 8 | Day 8 | 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 |
| Reviewer Assessment of Visible Wound Improvement | Day 8 | 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). |
| Satisfaction: Wound Pain, Day 8 | Day 8 | 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. |
| Satisfaction: Difficulty of Use/Care, Day 8 | Day 8 | 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). |
| Inflammatory Biomarker MMP-9 | Day 0 (Baseline), Day 4, Day 8 | 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. |
| Inflammatory Biomarker IL6 | Day 0 (Baseline), Day 4, Day 8 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Larval Debridement Therapy: small sterile mesh bags containing live maggots placed into an open chronic wound to remove necrotic tissue and bacterial biofilm | 18 |
| 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.
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 | 16 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | pt taking excluded medication | 3 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
| Overall Study | wound healed | 0 | 2 |
Baseline characteristics
| Characteristic | Sharp Debridement Therapy | Total | Larval Debridement Therapy |
|---|---|---|---|
| Age, Continuous | 64.9 years STANDARD_DEVIATION 6.6 | 65.4 years STANDARD_DEVIATION 7.89 | 65.9 years STANDARD_DEVIATION 8.5 |
| Current Smokers | 5 Participants | 8 Participants | 3 Participants |
| History of wounds History of diabetic lower extremity wounds | 11 Participants | 21 Participants | 10 Participants |
| History of wounds None documented | 0 Participants | 2 Participants | 2 Participants |
| History of wounds Other lower extremity wounds | 2 Participants | 4 Participants | 2 Participants |
| History of wounds Venous leg ulcers | 3 Participants | 7 Participants | 4 Participants |
| Marital/partner status Declined to answer | 0 Participants | 2 Participants | 2 Participants |
| Marital/partner status Married/partner | 7 Participants | 14 Participants | 7 Participants |
| Marital/partner status Single | 9 Participants | 17 Participants | 8 Participants |
| Marital/partner status Widow/Widower | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black/African American | 4 Participants | 7 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Not documented | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White/Caucasian | 11 Participants | 22 Participants | 11 Participants |
| Region of Enrollment United States | 16 Participants | 34 Participants | 18 Participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Male | 13 Participants | 29 Participants | 16 Participants |
| Suspected duration of wound at enrollment Not documented | 0 Participants | 2 Participants | 2 Participants |
| Suspected duration of wound at enrollment One year or longer duration | 8 Participants | 13 Participants | 5 Participants |
| Suspected duration of wound at enrollment Over 6 months but under 1 year duration | 2 Participants | 9 Participants | 7 Participants |
| Suspected duration of wound at enrollment Over 8 weeks but under 6 months duration | 5 Participants | 7 Participants | 2 Participants |
| Suspected duration of wound at enrollment Over 8 weeks unknown total duration | 1 Participants | 3 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 18 | 1 / 16 |
| other Total, other adverse events | 0 / 18 | 0 / 16 |
| serious Total, serious adverse events | 0 / 18 | 0 / 16 |
Outcome results
Primary
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).
Time frame: Day 0 (Baseline), Day 4, Day 8
Population: Statistical analysis was performed on a subset of participants (n=33) due to missing data on one or more days of measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Larval Debridement Therapy | 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 |
| Larval Debridement Therapy | 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 |
| Larval Debridement Therapy | 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 |
| Sharp Debridement Therapy | Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed), With MacConkey Agar Plating | Day 0 | 5.4009 Natural Log Transformed Bacterial CFU | Standard Deviation 4.76243 |
| Sharp Debridement Therapy | Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed), With MacConkey Agar Plating | Day 4 | 6.2482 Natural Log Transformed Bacterial CFU | Standard Deviation 4.32648 |
| Sharp Debridement Therapy | Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed), With MacConkey Agar Plating | Day 8 | 6.8660 Natural Log Transformed Bacterial CFU | Standard Deviation 4.80509 |
Comparison: 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.p-value: 0.037Repeated Measures ANOVA
Primary
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).
Time frame: Day 0 (Baseline), Day 4, Day 8
Population: Statistical analysis was performed on a subset of participants (n=33) due to missing data on one or more days of measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Larval Debridement Therapy | 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 4.4521 |
| Larval Debridement Therapy | 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 |
| Larval Debridement Therapy | 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 |
| Sharp Debridement Therapy | Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed),With Phenylethyl Alcohol (PEA) Plating | Day 0 | 8.7514 Natural Log Transformed Bacterial CFU | Standard Deviation 1.5658 |
| Sharp Debridement Therapy | Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed),With Phenylethyl Alcohol (PEA) Plating | Day 4 | 8.5673 Natural Log Transformed Bacterial CFU | Standard Deviation 2.64319 |
| Sharp Debridement Therapy | Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed),With Phenylethyl Alcohol (PEA) Plating | Day 8 | 9.7341 Natural Log Transformed Bacterial CFU | Standard Deviation 2.52994 |
Comparison: 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.p-value: 0.012Repeated Measures ANOVA
Primary
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).
Time frame: Day 0 (Baseline), Day 4, Day 8
Population: Statistical analysis was performed on a subset of participants (n=32) due to missing data on one or more days of measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Larval Debridement Therapy | 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 |
| Larval Debridement Therapy | 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 1.688 |
| Larval Debridement Therapy | 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 |
| Sharp Debridement Therapy | Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed), With Tryptic Soy Agar (TSA) Plating | Day 0 | 9.6880 Natural Log Transformed Bacterial CFU | Standard Deviation 1.75013 |
| Sharp Debridement Therapy | Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed), With Tryptic Soy Agar (TSA) Plating | Day 4 | 9.1547 Natural Log Transformed Bacterial CFU | Standard Deviation 2.57417 |
| Sharp Debridement Therapy | Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed), With Tryptic Soy Agar (TSA) Plating | Day 8 | 10.4479 Natural Log Transformed Bacterial CFU | Standard Deviation 2.25869 |
Comparison: 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.p-value: 0.029Repeated Measures ANOVA
Secondary
Inflammatory Biomarker IL6
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
Population: Statistical analysis was performed on a subset of participants (n=27) due to missing data on one or more days of measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Larval Debridement Therapy | Inflammatory Biomarker IL6 | Day 0 | 3.4889 Natural Log Transformed IL6 in ng/ml | Standard Deviation 1.29396 |
| Larval Debridement Therapy | Inflammatory Biomarker IL6 | Day 4 | 4.2287 Natural Log Transformed IL6 in ng/ml | Standard Deviation 1.65271 |
| Larval Debridement Therapy | Inflammatory Biomarker IL6 | Day 8 | 4.0069 Natural Log Transformed IL6 in ng/ml | Standard Deviation 1.3746 |
| Sharp Debridement Therapy | Inflammatory Biomarker IL6 | Day 0 | 3.5748 Natural Log Transformed IL6 in ng/ml | Standard Deviation 1.94347 |
| Sharp Debridement Therapy | Inflammatory Biomarker IL6 | Day 4 | 4.2233 Natural Log Transformed IL6 in ng/ml | Standard Deviation 1.18058 |
| Sharp Debridement Therapy | Inflammatory Biomarker IL6 | Day 8 | 4.0096 Natural Log Transformed IL6 in ng/ml | Standard Deviation 1.68661 |
Comparison: 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.p-value: 0.979Repeated Measures ANOVA
Secondary
Inflammatory Biomarker MMP-9
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
Population: Statistical analysis was performed on a subset of participants (n=20) due to missing data on one or more days of measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Larval Debridement Therapy | Inflammatory Biomarker MMP-9 | Day 0 | 2.8538 Natural Log Transformed MMP-9 in pg/ml | Standard Deviation 0.83493 |
| Larval Debridement Therapy | Inflammatory Biomarker MMP-9 | Day 4 | 2.7847 Natural Log Transformed MMP-9 in pg/ml | Standard Deviation 0.76985 |
| Larval Debridement Therapy | Inflammatory Biomarker MMP-9 | Day 8 | 2.9985 Natural Log Transformed MMP-9 in pg/ml | Standard Deviation 0.63257 |
| Sharp Debridement Therapy | Inflammatory Biomarker MMP-9 | Day 0 | 2.8965 Natural Log Transformed MMP-9 in pg/ml | Standard Deviation 0.8701 |
| Sharp Debridement Therapy | Inflammatory Biomarker MMP-9 | Day 4 | 2.7260 Natural Log Transformed MMP-9 in pg/ml | Standard Deviation 0.71122 |
| Sharp Debridement Therapy | Inflammatory Biomarker MMP-9 | Day 8 | 2.6861 Natural Log Transformed MMP-9 in pg/ml | Standard Deviation 0.84722 |
Comparison: 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.p-value: 0.661Repeated Measures ANOVA
Secondary
Reviewer Assessment of Visible Wound Improvement
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Larval Debridement Therapy | Reviewer Assessment of Visible Wound Improvement | 61.11 percentage of reviewers | Standard Deviation 39.503 |
| Sharp Debridement Therapy | Reviewer Assessment of Visible Wound Improvement | 71.88 percentage of reviewers | Standard Deviation 32.755 |
p-value: 0.397t-test, 2 sided
Secondary
Satisfaction: Aesthetic Unpleasantness of Debridement, Day 8
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
Population: Statistical analysis was performed on a subset of participants (n=32) due to missing data on one or more measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Larval Debridement Therapy | Satisfaction: Aesthetic Unpleasantness of Debridement, Day 8 | 2.63 score on a scale | Standard Deviation 2.872 |
| Sharp Debridement Therapy | Satisfaction: Aesthetic Unpleasantness of Debridement, Day 8 | 3.75 score on a scale | Standard Deviation 4.266 |
Comparison: 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).p-value: 0.415Kolmogorov-Smirnov Z
Secondary
Satisfaction: Difficulty of Use/Care, Day 8
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
Population: Statistical analysis was performed on a subset of participants (n=31) due to missing data on one or more measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Larval Debridement Therapy | Satisfaction: Difficulty of Use/Care, Day 8 | 1.60 score on a scale | Standard Deviation 2.53 |
| Sharp Debridement Therapy | Satisfaction: Difficulty of Use/Care, Day 8 | 1.88 score on a scale | Standard Deviation 3.243 |
Comparison: 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).p-value: 0.993Kolmogorov-Smirnov Z
Secondary
Satisfaction With Debridement: Overall Satisfaction With Method, Day 8
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
Population: Statistical analysis was performed on a subset of participants (n=30) due to missing data on one or more measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Larval Debridement Therapy | Satisfaction With Debridement: Overall Satisfaction With Method, Day 8 | 7.27 score on a scale | Standard Deviation 3.642 |
| Sharp Debridement Therapy | Satisfaction With Debridement: Overall Satisfaction With Method, Day 8 | 7.13 score on a scale | Standard Deviation 3.642 |
Comparison: 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).p-value: 0.999Kolmogorov-Smirnov Z
Secondary
Satisfaction: Wound Pain, Day 8
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
Population: Statistical analysis was performed on a subset of participants (n=30) due to missing data on one or more measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Larval Debridement Therapy | Satisfaction: Wound Pain, Day 8 | 4.14 DVPRS (Pain) Score | Standard Deviation 3.11 |
| Sharp Debridement Therapy | Satisfaction: Wound Pain, Day 8 | 3.63 DVPRS (Pain) Score | Standard Deviation 3.284 |
Comparison: 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).p-value: 0.99Kolmogorov-Smirnov Z