Biological Meshes in Infected Fields: a Randomized Controlled Trial

PHASE3CompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

March 28, 2019

Study Completion Date

March 28, 2019

Conditions
Ventral Hernia
Interventions
BIOLOGICAL

Biological mesh

patients will undergo the implantation of a biological mesh (after debridement and treatment of the infection) at the same time as the primary operation, or within one month of randomization.

PROCEDURE

without biological mesh

patients undergo traditional wound care (debridement and treatment of infection), without placement of a biological mesh. For arm B, the common wound care used follows the normal practice of the treating surgeon, except the placement of the biological mesh, which must not be performed within 6 months of randomization In cases of treatment failure at 6 months, patients of arm B are allowed to undergo any treatment which the treating surgeon views suitable, including a surgical procedure with implantation of a biological mesh

Trial Locations (1)

59037

Claude Huriez Hospital, University hospital, Lille

All Listed Sponsors
lead

University Hospital, Lille

OTHER

NCT01594450 - Biological Meshes in Infected Fields: a Randomized Controlled Trial | Biotech Hunter | Biotech Hunter