Maggot Therapy for Wound Debridement (MAGGOT)
Primary Purpose
Pressure Ulcers
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
application of wound dressing made of bio-bags (vitapads) containing maggots
application of classical hydrogel/alginate wound dressing
Sponsored by
About this trial
This is an interventional treatment trial for Pressure Ulcers
Eligibility 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
Sites / Locations
- Hospital of Caen, dermatology department
- Robert Bisson Hospital
- Hopital des armées Desgenettes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Maggot Debridement Therapy
control
Arm Description
Outcomes
Primary Outcome Measures
Percent of Fibrin changes from day 0 to day 15
Secondary Outcome Measures
Percent of healing changes from day 0 to day 15
Full Information
NCT ID
NCT01211236
First Posted
September 28, 2010
Last Updated
September 28, 2010
Sponsor
University Hospital, Caen
Collaborators
Société de Dermatologie Française
1. Study Identification
Unique Protocol Identification Number
NCT01211236
Brief Title
Maggot Therapy for Wound Debridement
Acronym
MAGGOT
Official Title
Maggot Therapy for Wound Debridement: a Randomized Multicentric Double-blind Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Caen
Collaborators
Société de Dermatologie Française
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Maggot Debridement Therapy
Arm Type
Experimental
Arm Title
control
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
application of wound dressing made of bio-bags (vitapads) containing maggots
Intervention Type
Other
Intervention Name(s)
application of classical hydrogel/alginate wound dressing
Primary Outcome Measure Information:
Title
Percent of Fibrin changes from day 0 to day 15
Secondary Outcome Measure Information:
Title
Percent of healing changes from day 0 to day 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hospital of Caen, dermatology department
City
Caen
State/Province
Calvados
ZIP/Postal Code
14000
Country
France
Facility Name
Robert Bisson Hospital
City
Lisieux
State/Province
Calvados
ZIP/Postal Code
14107
Country
France
Facility Name
Hopital des armées Desgenettes
City
Lyon
State/Province
Rhone
ZIP/Postal Code
69000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
22184720
Citation
Opletalova K, Blaizot X, Mourgeon B, Chene Y, Creveuil C, Combemale P, Laplaud AL, Sohyer-Lebreuilly I, Dompmartin A. Maggot therapy for wound debridement: a randomized multicenter trial. Arch Dermatol. 2012 Apr;148(4):432-8. doi: 10.1001/archdermatol.2011.1895. Epub 2011 Dec 19.
Results Reference
derived
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Maggot Therapy for Wound Debridement
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