Clinical trial NCT01211236: Maggot Therapy for Wound Debridement
Official title: Maggot Therapy for Wound Debridement: a Randomized Multicentric Double-blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pressure Ulcers
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Société de Dermatologie Française
First posted: 2010-09-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percent of Fibrin changes from day 0 to day 15
Secondary outcomes:
measure: Percent of healing changes from day 0 to day 15
Other outcomes:
Locations:
city: Caen
country: France
facility: Hospital of Caen, dermatology department
state: Calvados
city: Lisieux
country: France
facility: Robert Bisson Hospital
state: Calvados
city: Lyon
country: France
facility: Hopital des armées Desgenettes
state: Rhone
Study officials:
References:
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.