Maggot Therapy for Wound Debridement

NCT01211236 | Completed Phase 3 DMC

• 1 other identifier: PHRC04-130
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Pressure Ulcers

Outcome Measures

Primary Outcomes (1)

• Percent of Fibrin changes from day 0 to day 15

Secondary Outcomes (1)

• Percent of healing changes from day 0 to day 15

Study Arms (2)

Maggot Debridement Therapy

EXPERIMENTAL

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

control

ACTIVE COMPARATOR

Other: application of classical hydrogel/alginate wound dressing

Interventions

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

Maggot Debridement Therapy

application of classical hydrogel/alginate wound dressing OTHER

control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patients pregnant or lactating
• patients with neuropathy
• patients perforant ulcer of the foot
• patients with dementia

Sponsors & Collaborators

• University Hospital, Caen: lead
• Société de Dermatologie Française: collaborator

Study Sites (3)

Hospital of Caen, dermatology department

Caen, Calvados, 14000, France

Location

Robert Bisson Hospital

Lisieux, Calvados, 14107, France

Location

Hopital des armées Desgenettes

Lyon, Rhone, 69000, France

Location

Related Publications (1)

• 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.

  PMID: 22184720 DERIVED

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 28, 2010
• First Posted: September 29, 2010
• Study Start: February 1, 2006
• Last Updated: September 29, 2010

Record last verified: 2010-09

Locations

FR (3)