Clinical Trials Logo

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.


Clinical Trial Description

n/a


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


NCT number NCT01211236
Study type Interventional
Source University Hospital, Caen
Contact
Status Completed
Phase Phase 3
Start date February 2006

See also
  Status Clinical Trial Phase
Completed NCT02930590 - Effects of Different Support Surfaces on the Properties Skin After Loading N/A
Completed NCT02224404 - Post Market Clinical Follow-up Investigation to Evaluate Performance and Safety on Pressure Ulcers, PU, When Using Exufiber as Intended N/A
Completed NCT01965444 - A Test of the Investigational SEM Scanner N/A
Withdrawn NCT00623948 - Implanted Gluteal Stimulation System for Pressure Sore Prevention N/A
Terminated NCT01433159 - Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury Phase 2
Recruiting NCT01355666 - Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting N/A
Completed NCT01403272 - Evaluate the Efficacy of a Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting N/A
Completed NCT01008254 - Interdisciplinary Mobility Approach To Reduction Of Facility-Acquired Pressure Ulcers Phase 2/Phase 3
Completed NCT00971048 - Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds N/A
Terminated NCT00762138 - The AutoloGel™ Post-Market Surveillance (TAPS) Program N/A
Completed NCT00507650 - Increasing Fluids in Older Adults to Prevent & Treat Pressure Ulcers N/A
Completed NCT01877681 - Reference Nurse Program for Pressure Ulcers in Primary Care Phase 2
Completed NCT01232764 - Pressure Ulcer Multi-disciplinary Teams Via Telemedicine (PUMTT): A Trial in Long Term Care Phase 3
Completed NCT06374563 - Tackling Pressure Ulcer Via Bee Venom Phonophoresis N/A
Completed NCT03070925 - Prospective PuraPly™ AM Case Series Study N/A
Completed NCT02894437 - Qualitative Study of Preventive Organization of the Pelvic Bedsores Injured Spinal Cord
Completed NCT01348581 - Use of Fish Skin Extracellular Matrix (ECM) to Facilitate Chronic Wound Healing N/A
Completed NCT00771238 - Pilot Study of Incidence and Change in Existing Pressure Ulcers: TC500 Bed Compared With Standard Beds N/A
Completed NCT00763282 - Self-Management to Prevent Ulcers in Veterans With SCI (Spinal Cord Injury) N/A
Completed NCT01885962 - Development and Feasibility of an Internet Intervention for Adults With Spinal Cord Injury to Prevent Pressure Ulcers N/A