NCT04681326

Prophylactic Implantation of Biologic Mesh in Peritonitis

Status unknown NA Last updated 23 December 2020

What this trial tests

NA trial testing biological prosthesis in Incisional Hernia in 90 participants. Status unknown.

Timeline

1 December 2020

Primary endpoint
1 December 2023

1 December 2023

Quick facts

Lead sponsor	Azienda Ospedaliero-Universitaria di Parma
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	90
Start date	1 December 2020
Primary completion	1 December 2023
Estimated completion	1 December 2023
Sites	1 location across Italy

Drugs / interventions tested

• biological prosthesis

Conditions studied

• Incisional Hernia — all drugs for Incisional Hernia →
• Peritonitis — all drugs for Peritonitis →

Sponsor

Azienda Ospedaliero-Universitaria di Parma — full company profile →

Who can join

18 and older, any sex, with Incisional Hernia or Peritonitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients undergoing emergency surgery for peritonitis are at increased risk of abdominal wall-related complications. In patients with peritonitis the risk of incisional hernia (IH) is extremely elevated. The incidence of IH in patients operated with peritonitis is up to 54 %, compared with an incidence of 11-26 % in the general surgical population. Moreover, up to 24.1 % of patients with peritonitis undergoing emergency laparotomy may develop fascial dehiscence. The evaluation of quality of life of patients with IH showed lower mean scores on physical components of health-related quality of life and body image. The prophylactic mesh implantation demonstrated to reduce the incisional hernia rate in patients undergoing vascular or bariatric procedures. However, the intraperitoneal non absorbable mesh implantation in infected fields is generally considered at least of doubtful safety because of the theoretical increased risk of chronic mesh infection and enterocutaneous fistula. Most incisional hernias develop during the first three months after surgery, which represents the critical period for the healing of transected muscular and fibrous layers of the abdominal wall. However, most studies recommended a long-term follow up period of up to at least 5 years for midline abdominal incisions to determine the real incisional hernia rate. The midline abdominal incision is preferred in abdominal surgery, as it provides wide and rapid access compared other incisions. However, the incidence of incisional hernias is higher following midline abdominal incisions than in other abdominal incisions. In emergency surgery the midline incision in the majority of cases is a necessity. Several factors affect the process of wound healing: surgical site infection, poor surgical technique, and patient-related factors (i.e. peritonitis, old age, obesity, diabetes mellitus, nutritional deficiencies, hepatic cirrhosis, jaundice, renal impairment, malignancy, cardiac disease, chest problems, previous abdominal incisions, steroid therapy). Data about the use of biological prosthesis in infected fields are scarce and derive principally from case reports and case series. However, indications about their use and usefulness in infected fields have been recently published by the Italian Biological Prosthesis Working Group (IBPWG). A previously published prospective observational study evaluated the efficacy of implantation of biological prosthesis in high risk patients in order to reduce the incidence of incisional hernia. This study suggested the efficacy of this kind of prosthesis in reducing incisional hernia rate in patients with multiple risk factors. A recently published meta-analysis showed as the use of biological prosthesis in ventral hernia repair resulted in a lower infectious wound complication rate but in an similar recurrence rate. These results supports the application of biological prosthesis in high risk patients. One recent systematic review evaluated the positive effect on incisional hernia rate of the prophylactic mesh positioning in high risk patients. No randomized trials have been published since now about the use of biological prosthesis in contaminated or infected fields. The rationale of the trial is to evaluate the efficacy of the use of swine dermal collagen prosthesis implanted preperitoneally as a prophylactic procedure against incisional hernia in patients operated in urgency/emergency setting in contaminated/infected fields with peritonitis. The aim of the study is to reduce the incidence of incisional hernia from 50% to 20%.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. PROPHYlactic Implantation of BIOlogic Mesh in peritonitis (PROPHYBIOM): a prospective multicentric randomized controlled trial.
   Coccolini F, Tarasconi A, Petracca GL, Perrone G, et al · · 2022 · cited 1× · PMID 35246206 · DOI 10.1186/s13063-022-06103-4
2. Prophylactic Implantation of Biologic Mesh in Peritonitis (PROPHYBIOM): A Prospective Multicentric Randomized Controlled Trial.
   Coccolini F, Tarasconi A, Petracca GL, Perrone G, et al · · 2021 · DOI 10.21203/rs.3.rs-654241/v1