Maggot Therapy for Wound Debridement (MAGGOT)

Caen University Hospital

Status and phase: Completed; Phase 3

Conditions: Pressure Ulcers

Treatments: Other: application of classical hydrogel/alginate wound dressing; Other: application of wound dressing made of bio-bags (vitapads) containing maggots

Study type: Interventional

Funder types: Other

Identifiers

NCT01211236

PHRC04-130

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

Maggot Debridement Therapy

Experimental group

Treatment:

Other: application of wound dressing made of bio-bags (vitapads) containing maggots

control

Active Comparator group

Treatment:

Other: application of classical hydrogel/alginate wound dressing