Maggot Therapy for Wound Debridement

Study Overview
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Brief Summary
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The main objective of the trial was to study the efficacy of bagged larvae on wound debridement in comparison to classical treatments. The secondary outcome was to assess wound healing, treatment related pain, microbiological modifications, adverse events, comfort of the dressing and duration of wound care. We performed a randomized, double-blind, multicenter, controlled, prospective phase III trial in three referral institutional centers of hospitalized care in Caen, Lisieux and Lyon, France. A total of 120 patients with a non-healing fibrinous wound ≤ 40cm2, less than 2cm-deep, and an ankle-brachial pressure index (ABPI) ≥ 0.8 were included, from March 2005 to December 2008. During two weeks´ hospitalization, patients received either Maggot Debridement Therapy (MDT, changes of bagged larvae twice a week) or classical treatments (mechanical debridement and classical dressings performed three times a week). At discharge, classical dressings were applied and a follow-up visit performed at D30. Main outcome measure was the comparison of the reduction of fibrin percentage on wounds treated with MDT and classical treatments at D15. The percentages of fibrin were measured using a computerized planimetry software package, Canvas (ACD Systems, British Columbia, Canada), which enables the quantification of color surface variations in a wound after manual delimitation (using a mouse) on a series of photographic images.

Official Title
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Maggot Therapy for Wound Debridement: a Randomized Multicentric Double-blind Trial

Conditions
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Pressure Ulcers

Intervention / Treatment
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* Other: application of wound dressing made of bio-bags (vitapads) containing maggots
* Other: application of classical hydrogel/alginate wound dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient between 18 and 90 years old patients with a non-healing fibrinous wound ≤ 40cm2 (pressure ulcer or venous ulcers pressure ulcers were less than 2cm-deep limb wounds were venous ulcers with an ankle-brachial pressure (ABP)≥ 0.8 signed informed consent Exclusion Criteria: patients pregnant or lactating patients with neuropathy patients perforant ulcer of the foot patients with dementia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maggot Debridement Therapy<br> | Other: application of wound dressing made of bio-bags (vitapads) containing maggots<br> <br> |
| Active Comparator: control<br> | Other: application of classical hydrogel/alginate wound dressing<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Fibrin changes from day 0 to day 15 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of healing changes from day 0 to day 15 |  |  |