Maggot Therapy for Wound Debridement (MAGGOT)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pressure Ulcers |
Other: application of wound dressing made of bio-bags (vitapads) containing maggots Other: application of classical hydrogel/alginate wound dressing |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Maggot Therapy for Wound Debridement: a Randomized Multicentric Double-blind Trial |
- Percent of Fibrin changes from day 0 to day 15
- Percent of healing changes from day 0 to day 15
| Enrollment: | 120 |
| Study Start Date: | February 2006 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Maggot Debridement Therapy | Other: application of wound dressing made of bio-bags (vitapads) containing maggots |
| Active Comparator: control | Other: application of classical hydrogel/alginate wound dressing |
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| France | |
| Hospital of Caen, dermatology department | |
| Caen, Calvados, France, 14000 | |
| Robert Bisson Hospital | |
| Lisieux, Calvados, France, 14107 | |
| Hopital des armées Desgenettes | |
| Lyon, Rhone, France, 69000 | |
More Information
No publications provided by University Hospital, Caen
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT01211236 History of Changes |
| Other Study ID Numbers: | PHRC04-130 |
| Study First Received: | September 28, 2010 |
| Last Updated: | September 28, 2010 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Pressure Ulcer Ulcer Skin Ulcer Skin Diseases Pathologic Processes Alginic acid Hemostatics |
Coagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Radiation-Protective Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013