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Biosynthetic Absorbable Mesh vs Standard of Repair for the Surgical Treatment of Infected Incisional Hernia (COMpACT-BIO)

Primary Purpose

Ventral Hernia Repair

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Incisional hernia repair with reinforcement of biosynthetic mesh
Incisional hernia repair with simple suture or synthetic mesh reinforcement.
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Other

Arm Label

biosynthetic mesh group

standard of repair group

Arm Description

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).

Outcomes

Primary Outcome Measures

Rate of incisional hernia recurrence
The rate of incisional hernia recurrence will be evaluated by radiologic imaging.

Secondary Outcome Measures

Days of hospitalization related to incisional hernia repair
Number of days of hospitalization related to hernia repair-related complications will be reported.
Incidence of re-operation related to incisional hernia repair
Incidence of incisional hernia repair-related complications leading to re-operation will be reported.
Incidence of wound events
Incidence of incisional hernia repair-related wound complications, such as wound infection will be reported.
Incidence of revision surgery or interventional radiologic procedure
Incidence of revision surgery or interventional radiologic procedure related incisional hernia repair-related wound complications will be reported.
Rate of early incisional hernia recurrence
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
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
At each clinical examination, the time between surgery and the end of median scar care will be measured.
Rate of screening failure
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
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.

Full Information

First Posted
July 31, 2020
Last Updated
June 29, 2022
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT04597840
Brief Title
Biosynthetic Absorbable Mesh vs Standard of Repair for the Surgical Treatment of Infected Incisional Hernia
Acronym
COMpACT-BIO
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2021 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia Repair
Keywords
ventral hernia repair, contaminated surgical field, infected incisional hernia, biosynthetic mesh

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The type of incisional hernia repair (simple suture or mesh reinforcement) will be masked to the primary outcome assessor.
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
biosynthetic mesh group
Arm Type
Experimental
Arm Description
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.
Arm Title
standard of repair group
Arm Type
Other
Arm Description
Patient will undergo incisional hernia repair according to the standard of repair, which is simple suture or mesh reinforcement (using synthetic or biological meshes).
Intervention Type
Procedure
Intervention Name(s)
Incisional hernia repair with reinforcement of biosynthetic mesh
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Incisional hernia repair with simple suture or synthetic mesh reinforcement.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of incisional hernia recurrence
Description
The rate of incisional hernia recurrence will be evaluated by radiologic imaging.
Time Frame
3 years after surgery
Secondary Outcome Measure Information:
Title
Days of hospitalization related to incisional hernia repair
Description
Number of days of hospitalization related to hernia repair-related complications will be reported.
Time Frame
For 3 years after surgery
Title
Incidence of re-operation related to incisional hernia repair
Description
Incidence of incisional hernia repair-related complications leading to re-operation will be reported.
Time Frame
For 3 years after surgery
Title
Incidence of wound events
Description
Incidence of incisional hernia repair-related wound complications, such as wound infection will be reported.
Time Frame
1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date
Title
Incidence of revision surgery or interventional radiologic procedure
Description
Incidence of revision surgery or interventional radiologic procedure related incisional hernia repair-related wound complications will be reported.
Time Frame
1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date
Title
Rate of early incisional hernia recurrence
Description
The rate of incisional hernia recurrence evaluated by physical examination and then confirmed by radiologic imaging will be reported.
Time Frame
1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date
Title
Incisional hernia specific quality-of-life assessment
Description
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).
Time Frame
Pre and post-surgery (1 month from surgery date, then 3, 6, 12, 24 and 36 months from surgery date).
Title
Number of healing days
Description
At each clinical examination, the time between surgery and the end of median scar care will be measured.
Time Frame
1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date
Title
Rate of screening failure
Description
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.
Time Frame
48 months after the start of the study
Title
Assessment of health care consumption related to health care status
Description
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.
Time Frame
pre and post-surgery (1 month from surgery date, then 3, 6, 12, 24 and 36 months from surgery date).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume PASSOT, Pr
Phone
4 78 86 23 71
Ext
+33
Email
guillaume.passot@chu-lyon.fr
Facility Information:
Facility Name
Hôpital Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume PASSOT, Pr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36008058
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.
Results Reference
derived

Learn more about this trial

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

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