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Maggot Therapy for Wound Debridement

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01211236
Acronym
MAGGOT
Enrollment
120
Registered
2010-09-29
Start date
2006-02-28
Completion date
Unknown
Last updated
2010-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Ulcers

Brief summary

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.

Interventions

OTHERapplication of wound dressing made of bio-bags (vitapads) containing maggots
OTHERapplication of classical hydrogel/alginate wound dressing

Sponsors

Société de Dermatologie Française
CollaboratorOTHER
University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
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

Design outcomes

Primary

MeasureTime frame
Percent of Fibrin changes from day 0 to day 15

Secondary

MeasureTime frame
Percent of healing changes from day 0 to day 15

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026