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Completed

NCT Number: NCT01211236

Maggot Therapy for Wound Debridement

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital of Caen, dermatology department, Caen, Calvados, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

application of classical hydrogel/alginate wound dressing

Other

Primary outcomes

  1. Percent of Fibrin changes from day 0 to day 15

Secondary outcomes

  1. Percent of healing changes from day 0 to day 15

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Collaborators

  • Société de Dermatologie Française

Registry information

Official study title

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

Acronym: MAGGOT

Important dates

Study start
2006
First posted
Sep 29, 2010
Registry last updated
Sep 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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