Maggot Therapy for Wound Debridement

Pressure Ulcers Clinical Trial

— MAGGOT  

Official title:

Maggot Therapy for Wound Debridement: a Randomized Multicentric Double-blind Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01211236
• Other study ID #: PHRC04-130
• Status: Completed
• Phase: Phase 3
• First received: September 28, 2010
• Last updated: September 28, 2010
• Start date: February 2006

Study information

• Verified date: September 2010
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcers

Intervention

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

• application of classical hydrogel/alginate wound dressing

Locations

Country	Name	City	State
France	Hospital of Caen, dermatology department	Caen	Calvados
France	Robert Bisson Hospital	Lisieux	Calvados
France	Hopital des armées Desgenettes	Lyon	Rhone

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Caen	Société de Dermatologie Française

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Fibrin changes from day 0 to day 15
Secondary	Percent of healing changes from day 0 to day 15