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Maggot Therapy for Wound Debridement

NCT ID: NCT01211236

Last Updated: 2010-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Pressure Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Maggot Debridement Therapy

Group Type EXPERIMENTAL

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

Intervention Type OTHER

control

Group Type ACTIVE_COMPARATOR

application of classical hydrogel/alginate wound dressing

Intervention Type OTHER

Interventions

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

Intervention Type OTHER

application of classical hydrogel/alginate wound dressing

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société de Dermatologie Française

OTHER

Sponsor Role collaborator

University Hospital, Caen

OTHER

Sponsor Role lead

Locations

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Hospital of Caen, dermatology department

Caen, Calvados, France

Site Status

Robert Bisson Hospital

Lisieux, Calvados, France

Site Status

Hopital des armées Desgenettes

Lyon, Rhone, France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 22184720 (View on PubMed)

Other Identifiers

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PHRC04-130

Identifier Type: -

Identifier Source: org_study_id