Biosynthetic Absorbable Mesh vs Standard of Repair for the Surgical Treatment of Infected Incisional Hernia

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: October 2024

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.

Interventions

  • Procedure: Incisional hernia repair with reinforcement of biosynthetic mesh
    • The biosynthetic mesh (Phasix or Bio-A meshes) will be placed as a sublay in the retromuscular position to reinforce midline fascial closure. All the surgical procedure (including placement and fixation of the mesh) will be performed according to a standardized protocol.
  • Procedure: Incisional hernia repair with simple suture or synthetic mesh reinforcement.
    • Based on the discretion of the surgeon, the incisional hernia repair will be done by simple suture or by synthetic mesh reinforcement. All the surgical procedure (including placement and fixation of the mesh if applicable) will be performed according to a standardized protocol.

Arms, Groups and Cohorts

  • Experimental: biosynthetic mesh 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.
  • Other: standard of repair group
    • Patient will undergo incisional hernia repair according to the standard of repair, which is simple suture or mesh reinforcement (using synthetic or biological meshes).

Clinical Trial Outcome Measures

Primary Measures

  • Rate of incisional hernia recurrence
    • Time Frame: 3 years after surgery
    • The rate of incisional hernia recurrence will be evaluated by radiologic imaging.

Secondary Measures

  • Days of hospitalization related to incisional hernia repair
    • Time Frame: For 3 years after surgery
    • Number of days of hospitalization related to hernia repair-related complications will be reported.
  • Incidence of re-operation related to incisional hernia repair
    • Time Frame: For 3 years after surgery
    • Incidence of incisional hernia repair-related complications leading to re-operation will be reported.
  • Incidence of wound events
    • Time Frame: 1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date
    • Incidence of incisional hernia repair-related wound complications, such as wound infection will be reported.
  • Incidence of revision surgery or interventional radiologic procedure
    • Time Frame: 1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date
    • Incidence of revision surgery or interventional radiologic procedure related incisional hernia repair-related wound complications will be reported.
  • Rate of early incisional hernia recurrence
    • Time Frame: 1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date
    • The rate of incisional hernia recurrence evaluated by physical examination and then confirmed by radiologic imaging will be reported.
  • Incisional hernia specific quality-of-life assessment
    • Time Frame: Pre and post-surgery (1 month from surgery date, then 3, 6, 12, 24 and 36 months from surgery date).
    • Self reported clinical symptoms before and after incisional hernia repair will be done using a modified version of the Carolina Comfort Scale . Severity of pain and discomfort pre and post repair will be measured during different daily activities (item). Each item is scored 0-5 (0= no symptom ; 5= worst symptom).
  • Number of healing days
    • Time Frame: 1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date
    • At each clinical examination, the time between surgery and the end of median scar care will be measured.
  • Rate of screening failure
    • Time Frame: 48 months after the start of the study
    • The proportion of patients who did not receive the surgical procedure proposed by the study, and the related reasons of screening failure will be reported.
  • Assessment of health care consumption related to health care status
    • Time Frame: pre and post-surgery (1 month from surgery date, then 3, 6, 12, 24 and 36 months from surgery date).
    • The cost / quality ratio will be measured using the consumption of health care and the health status. In one hand, each health care action will be reported (by the patient or the caregiver) and then the total cost relative to the health care will be measured. In another hand, self-reported health status before and after incisional hernia repair will be done using the EQ-5D-5L questionnaire.

Participating in This Clinical Trial

Inclusion Criteria

  • – Age ≥18 years old – Patient having midline incisional hernia – Patient with elective surgery repair – Patient with contaminated wound (type III of the modified Ventral Hernia Working Group classification) – Patient covered by health insurance – Written informed consent obtained – No contraindication of retromuscular mesh repair Exclusion Criteria:

  • – One or multiple incisional hernia out of the midline incision – Incisional hernia with loss of domain – Patient with high operative risk (ASA (American Society of Anesthesiologists ) 4-5 in the ASAPS(physical status classification system ) classification) – Emergency incisional hernia – Pregnancy, breast-feeding, no contraceptive use – Known allergy to tetracycline antibiotics – Legal incapacity

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospices Civils de Lyon
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Guillaume PASSOT, Pr, 4 78 86 23 71, guillaume.passot@chu-lyon.fr

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