Clinical trial NCT04597840: Biosynthetic Absorbable Mesh vs Standard of Repair for the Surgical Treatment of Infected Incisional Hernia
Official title: Multicenter, Prospective, Longitudinal and Randomized Comparison of Both the Clinical and Economic Impact of Biosynthetic Absorbable Mesh to the Surgical Standard of Care in Contaminated Incisional Hernia Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventral Hernia Repair
Keywords: ventral hernia repair
contaminated surgical field
infected incisional hernia
biosynthetic mesh
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Incisional hernia is one of the most common complications of abdominal surgery and carries a significant burden for both patients and the economic health service. However, no consensus for the surgical treatment of incisional hernia in contaminated field is currently available. The purpose of the COMpACT-BIO study is to investigate the clinical and economic benefit of the use of biosynthetic mesh in contaminated incisional hernia repair.

Detailed description: The current standard of incisional hernia repair is reinforcement with permanent synthetic mesh. However, permanent synthetic mesh is contraindicated in contaminated surgical field due to higher risk of postoperative infection. In order to resist to infection, absorbable meshes, such as biological and biosynthetic meshes, have been developped. However, some controversies exist about the clinical benefit of biological meshes in the long term. Reasons for theses controversies are their overall risk of complication and recurrence and the lack of consensus in which surgical technique to apply. Moreover, the financial cost of biological meshes is very high. Recently developed, biosynthetic meshes appear to be a promising option ; Compared to biological meshes, they seem to have several advantages. However, such data demonstrating the beneficial use of biosynthetic mesh in contaminated incisional hernia repair is not available. In this regard, the COMpACT-BIO study aims to investigate the clinical and economic benefit of the use of biosynthetic mesh in contaminated incisional hernia repair in comparison to the standard of repair. This is a multicenter, prospective, longitudinal and randomized study, which also offers a standardized technique of repair.

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

Primary outcomes:
measure: Rate of incisional hernia recurrence
timeFrame: 3 years after surgery
Secondary outcomes:
measure: Days of hospitalization related to incisional hernia repair
timeFrame: For 3 years after surgery
measure: Incidence of re-operation related to incisional hernia repair
timeFrame: For 3 years after surgery
measure: Incidence of wound events
timeFrame: 1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date
measure: Incidence of revision surgery or interventional radiologic procedure
timeFrame: 1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date
measure: Rate of early incisional hernia recurrence
timeFrame: 1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date
measure: Incisional hernia specific quality-of-life assessment
timeFrame: Pre and post-surgery (1 month from surgery date, then 3, 6, 12, 24 and 36 months from surgery date).
measure: Number of healing days
timeFrame: 1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date
measure: Rate of screening failure
timeFrame: 48 months after the start of the study
measure: Assessment of health care consumption related to health care status
timeFrame: pre and post-surgery (1 month from surgery date, then 3, 6, 12, 24 and 36 months from surgery date).
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Hôpital Lyon Sud
Study officials:
References:
citation: Passot G, Margier J, Kefleyesus A, Rousset P, Ortega-Deballon P, Renard Y, Bin S, Villeneuve L. Slowly absorbable mesh versus standard care in the management of contaminated midline incisional hernia (COMpACT-BIO): a multicentre randomised controlled phase III trial including a health economic evaluation. BMJ Open. 2022 Aug 25;12(8):e061184. doi: 10.1136/bmjopen-2022-061184.