Ignite Creation Date:
2024-05-05 @ 10:54 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01211236
Status:
COMPLETED
Last Update Posted:
2010-09-29
First Post:
2010-09-28
Brief Title:
Maggot Therapy for Wound Debridement
Sponsor:
University Hospital Caen
Organization:
University Hospital Caen
Study Overview
Official Title:
Maggot Therapy for Wound Debridement a Randomized Multicentric Double-blind Trial
Status:
COMPLETED
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAGGOT
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 08 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None