Clinical trial NCT04471311: Safety and Efficacy of Prophylactic Re-sorbable Biosynthetic Mesh Following Midline Laparotomy in Clean/Contaminated Field.
Official title: Safety and Efficacy of Prophylactic Resorbable Biosynthetic Mesh Following Midline Laparotomy in Clean/Contaminated Field: Protocol for a Multicenter Randomized Double Blind Prospected Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Incisional Hernia After Midline Laparotomy
Keywords: Incisional Hernia
Midline laparotomy
Contaminated wound
Lead sponsor: Azienda Sanitaria Locale Napoli 2 Nord
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: THIS IS A CONTROLLED RANDOMIZED STUDY OF BINARY SUPERIORITY OUTCOME IN PARALLEL GROUPS. 302 PATIENTS ARE REQUIRED TO HAVE A 95% CHANCE OF DETECTING, AS SIGNIFICANT AT THE 5% LEVEL, A DECREASE IN THE PRIMARY OUTCOME MEASURE FROM 18% (INCISIONAL HERNIA RATE) IN THE CONTROL GROUP TO 5%(INCISIONAL HERNIA RATE) IN THE EXPERIMENTAL GROUP.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Incisional Hernia at Ultrasound examination
timeFrame: 3 months
measure: Rate of Incisional Hernia at Ultrasound examination
timeFrame: 6 months
measure: Rate of Incisional Hernia at Ultrasound examination
timeFrame: 12 months
measure: Rate of Incisional Hernia at Ultrasound examination
timeFrame: 24 months
measure: Rate of Incisional Hernia at Clinical examination
timeFrame: 3 months
measure: Rate of Incisional Hernia at Clinical examination
timeFrame: 6 months
measure: Rate of Incisional Hernia at Clinical examination
timeFrame: 12 months
measure: Rate of Incisional Hernia at Clinical examination
timeFrame: 24 months
Secondary outcomes:
measure: Number of patients affected by Superficial surgical site infections
timeFrame: Within 30 days postoperatively
measure: Number of patients affected by Deep surgical site infections
timeFrame: Within 30 days postoperatively
Other outcomes:
Locations:
city: Naples
country: Italy
facility: francesco Pizza
Study officials:
affiliation: Azienda Sanitaria Locale Napoli 2 Nord
name: Francesco Pizza
role: STUDY_DIRECTOR
References: