Maggot Therapy for Wound Debridement

Phase 3

Completed

• Conditions: Pressure Ulcers
• Interventions: Other: application of wound dressing made of bio-bags (vitapads) containing maggots; Other: application of classical hydrogel/alginate wound dressing

• Registration Number: NCT01211236
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Status Verified: 2010-09
• Study First Submitted: 2010-09-28
• Study First Submitted QC: 2010-09-28
• Last Update Submitted: 2010-09-28
• Study First Posted: 2010-09-29
• Last Update Posted: 2010-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maggot Debridement Therapy	application of wound dressing made of bio-bags (vitapads) containing maggots	-
control	application of classical hydrogel/alginate wound dressing	-

Primary Outcome Measures

Name	Time	Method
Percent of Fibrin changes from day 0 to day 15

Secondary Outcome Measures

Name	Time	Method
Percent of healing changes from day 0 to day 15

Trial Locations

Locations (3)

Hospital of Caen, dermatology department; 🇫🇷 Caen, Calvados, France

Robert Bisson Hospital; 🇫🇷 Lisieux, Calvados, France

Hopital des armées Desgenettes; 🇫🇷 Lyon, Rhone, France