NCT Number: NCT01211236
Maggot Therapy for Wound Debridement
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.
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Notify MeKey information
Conditions
Age range
18 year–90 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Hospital of Caen, dermatology department, Caen, Calvados, France
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
application of classical hydrogel/alginate wound dressing
OtherPrimary outcomes
-
Percent of Fibrin changes from day 0 to day 15
Secondary outcomes
-
Percent of healing changes from day 0 to day 15
Sponsors and collaborators
Lead sponsor
University Hospital, Caen
Other
Collaborators
- Société de Dermatologie Française
Registry information
Official study title
Maggot Therapy for Wound Debridement: a Randomized Multicentric Double-blind Trial
Acronym: MAGGOT
Important dates
- Study start
- 2006
- First posted
- Sep 29, 2010
- Registry last updated
- Sep 29, 2010
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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