Maggot Therapy for Wound Debridement

Last updated: September 28, 2010
Sponsor: University Hospital, Caen
Overall Status: Completed

Phase

3

Condition

Pressure Ulcer

Pressure Ulcers

Ulcers

Treatment

N/A

Clinical Study ID

NCT01211236
PHRC04-130
  • Ages 18-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • patients pregnant or lactating

  • patients with neuropathy

  • patients perforant ulcer of the foot

  • patients with dementia

Study Design

Total Participants: 120
Study Start date:
February 01, 2006
Estimated Completion Date:

Connect with a study center

  • Hospital of Caen, dermatology department

    Caen, Calvados 14000
    France

    Site Not Available

  • Robert Bisson Hospital

    Lisieux, Calvados 14107
    France

    Site Not Available

  • Hopital des armées Desgenettes

    Lyon, Rhone 69000
    France

    Site Not Available

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