Safety and Efficacy of Prophylactic Re-sorbable Biosynthetic Mesh Following Midline Laparotomy in Clean/Contaminated Field. (Parthenope)

A

Azienda Sanitaria Locale Napoli 2 Nord

Status

Enrolling

Conditions

Incisional Hernia After Midline Laparotomy

Treatments

Device: BIO-A (GORE) mesh
Procedure: Sub-lay mesh supported closure

Study type

Interventional

Funder types

Other

Identifiers

NCT04471311
1872020

Details and patient eligibility

About

The aim of the present study is to analyse the feasibility, safety and IH rate using a prophylactic sublay biosynthetic BIO-A (GORE) mesh in order to prevent incisional hernia following midline laparotomy in clean-contaminated and contaminated wounds. The study was designed as a double-blind randomized controlled trial comparing the running suture alone to the running suture reinforced with biosynthetic mesh (BIOA) in sub lay position.

Full description

Incisional Hernia (IH) is one of the most frequent postoperative complications in abdominal surgery causing significant morbidity and even mortality. The risk of developing an IH following primary elective midline laparotomy is reported to be between 5 and 20 percent. Risk factors for developing IH are both patient and surgery related. Patient factors include diabetes, smoking, obesity, chronic corticosteroids use and connective tissue disorders, comprised the presence of an Abdominal Aortic Aneurysm (AAA). Surgery related factors include type of laparotomy, type of surgery, wounds classification, suture material used to close the laparotomy and the suture length to wound length ratio (SL/WL). In patients carrying AAA and/or obesity and/or contaminated wounds, incidence rises to 39% (6,7). Besides the negative impact of incisional hernia regarding the patients' quality of life, the direct costs of hernia repair and indirect cost of IH (sick leave) are an important burden for the health care system. Several groups investigated the role of prophylactic mesh placement in the prevention of IH occurrence. A positive conclusion was reached by two systemic reviews. On the other side, surgeons are mostly reluctant to implant permanent material in patients undergoing a contaminated ventral hernia repair for the increased risk of postoperative infections, bowel adhesions, mesh extrusion and/or erosion, fistula formation, seroma development and pain. Recently, a retrospective study by Carbonell et al. investigated the feasibility and outcomes of open ventral hernia repairs performed with a polypropylene mesh in the retro-rectus position in clean-contaminated and contaminated fields, reporting a 30-day surgical site infection rate of 7.1 and 19.0% respectively. The most appropriate mesh for hernia repair in clean-contaminated and contaminated fields is not as clear . Some other authors proposed the implant of Biological Meshes (BM) in contaminated and dirty wounds, but their high costs limited their use. Moreover, data about long-term durability of biologic grafts used in case of complex abdominal wall reconstruction are not clearly defined. The so-called biosynthetic meshes (BSM) may, actually, offer advantages when challenging with bacterial colonization during complex abdominal wall reconstruction. The GORE BIO-A Tissue Reinforcement is a BSM composed of a bio-absorbable polyglycolide-trimethylene carbonate copolymer, which is gradually absorbed by the body. The aim of the present study is to analyse the feasibility, safety and IH rate using a prophylactic sublay biosynthetic BIO-A (GORE) mesh in order to prevent incisional hernia following midline laparotomy in clean-contaminated and contaminated wounds. The study was designed as a double-blind randomized controlled trial comparing the running suture alone to the running suture reinforced with biosynthetic mesh (BIOA) in sub lay position.

Enrollment

151 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

* age \> 18 years * Clean-contaminated, contaminated wounds • midline laparotomy \>10 cm * Informed consent

Exclusion criteria

* age \< 18 years; * life expectancy \< 24 months (as estimated by the operating surgeon), - • pregnancy * immunosuppressant therapy within 2 weeks before surgery * clean and dirty wounds * wound length\<10 cm.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

151 participants in 2 patient groups

Primary closure of midline laparotomy
No Intervention group
Description:
Primary closure of midline laparotomy
Sub-lay mesh supported closure
Experimental group
Description:
Sub-lay permanent mesh supported the closure
Treatment:
Device: BIO-A (GORE) mesh
Procedure: Sub-lay mesh supported closure

Trial contacts and locations

1

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Central trial contact

Francesco Pizza; Francesco Pizza

Data sourced from clinicaltrials.gov

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