Biosynthetic Absorbable Mesh vs Standard of Repair for the Surgical Treatment of Infected Incisional Hernia (COMpACT-BIO)
Ventral Hernia Repair
About this trial
This is an interventional treatment trial for Ventral Hernia Repair focused on measuring ventral hernia repair, contaminated surgical field, infected incisional hernia, biosynthetic mesh
Eligibility Criteria
All the following inclusion criteria must be fulfilled:
- Age ≥18 years old
- Physical status ASA < 4
- Patient with a mid-line IH
- Patient presenting with an IH without loss of domain
- Surgical indication in elective surgery
- "Potentially contaminated" grade III surgical environment according to the classification of the modified VHWG
- Cure of mid line IH feasible according to the defined standard technical modality (placement of a retromuscular prosthesis)
- No emergency surgical procedure
- Status of social insured or entitled to a social insurance
- Informed and signed consent of the patient after clear and appropriate information
The exclusion criteria are as follows:
- One or multiple incisional hernia out of the midline incision
- Pregnancy, breastfeeding, parturient or childbearing patients without contraception
- Known allergy to tetracyclines;
- Persons protected by law
Sites / Locations
- Hôpital Lyon SudRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Other
biosynthetic mesh group
standard of repair group
Patient will undergo incisional hernia repair with biosynthetic mesh reinforcement. Based on the discretion of the surgeon, two types of biosynthetic mesh from different brand can be used: the Phasix mesh from BARD or the BioA mesh from GORE. These two biosynthetic meshes are resorbable, which means they are gradually absorbed by the body.
Patient will undergo incisional hernia repair according to the standard of repair, which is simple suture or mesh reinforcement (using synthetic or biological meshes).