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Maggot Therapy for Wound Debridement (MAGGOT)

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ClinicalTrials.gov Identifier: NCT01211236
Recruitment Status : Completed
First Posted : September 29, 2010
Last Update Posted : September 29, 2010
Sponsor:
Collaborator:
Société de Dermatologie Française
Information provided by:
University Hospital, Caen

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.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Maggot Therapy for Wound Debridement: a Randomized Multicentric Double-blind Trial
Study Start Date : February 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Percent of Fibrin changes from day 0 to day 15

Secondary Outcome Measures :
  1. Percent of healing changes from day 0 to day 15


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01211236


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
Sponsors and Collaborators
University Hospital, Caen
Société de Dermatologie Française

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
First Posted: September 29, 2010    Key Record Dates
Last Update Posted: September 29, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Pressure Ulcer
Skin Ulcer
Skin Diseases
Alginic acid
Hemostatics
Coagulants
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs