Evidence map›Paper›PMID 35246206›Full record

Trial reportTrials2022

PROPHYlactic Implantation of BIOlogic Mesh in peritonitis (PROPHYBIOM): a prospective multicentric randomized controlled trial.

F Coccolini, A Tarasconi, G L Petracca, G Perrone, M Giuffrida, C Disisto, M Sartelli, P Carcoforo, L Ansaloni, F Catena

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04681326 (PROPHYlactic Implantation of BIOlogic Mesh in Peritonitis), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 40% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04681326 naunknown statusnot on this map

PROPHYlactic Implantation of BIOlogic Mesh in Peritonitis: a Prospective Multicentric Randomized Controlled Trial

TypeinterventionalSponsorAzienda Ospedaliero-Universitaria di ParmaRan2020 to 2023Enrolled90ConditionsIncisional Hernia, PeritonitisArmsbiological prosthesis
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 2 citations in OpenAlex.

  1. Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 1 country.

F CoccoliniGeneral Emergency and Trauma Surgery, Pisa University Hospital, Pisa, Italy.
A TarasconiEmergency Surgery Department, Parma University Hospital, Parma, Italy.
G L PetraccaEmergency Surgery Department, Parma University Hospital, Parma, Italy. glpetracca@gmail.com.ORCID http://orcid.org/0000-0003-0792-9464
G PerroneEmergency Surgery Department, Parma University Hospital, Parma, Italy.
M GiuffridaEmergency Surgery Department, Parma University Hospital, Parma, Italy.
C DisistoEmergency Surgery Department, Parma University Hospital, Parma, Italy.
M SartelliDepartment of Surgery, Macerata Hospital, Macerata, Italy.
P CarcoforoDepartment of Surgery, S. Anna University Hospital and University of Ferrara, Ferrara, Italy.
L AnsaloniGeneral Surgery, Pavia University Hospital, Pavia, Italy.
F CatenaEmergency Surgery Department, Parma University Hospital, Parma, Italy.
University of Parma · ITAzienda Ospedaliera Universitaria Pisana · ITOspedale di MacerataUniversity of Ferrara · ITUniversity of Pavia · IT

Funding

Ministero della Salute RF-2018-12368001
6 · The paper itself

Abstract

backgroundPatients 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 evaluation of quality of life of patients with incisional hernia showed lower mean scores on physical components of health-related quality of life and body image. Furthermore, the arise of a post-operative abdominal wall complication (i.e., wound dehiscence, evisceration and IH) greatly increases morbidity and mortality rates and prolongs the hospitalization.

methodsThe present study aims to evaluate the efficacy of the use of a swine dermal collagen prosthesis implanted preperitoneally as a prophylactic procedure in urgency/emergency setting against abdominal wall complications in patients operated with contaminated/infected field in peritonitis. The sample size was defined in 90 patients divided in two arms (prosthesis positioning versus normal wall abdominal closure). The follow-up will be performed at 3, 6, and 12 months after surgery. The percentage of incisional hernias, wound infections, and adverse events will be investigated by physical examination and ultrasound. DISCUSSION: The objective is to evaluate the possibility to reduce the incisional hernia rate in patients undergoing urgent/emergent laparotomy in contaminated/infected field with peritonitis by using swine dermal collagen prosthesis preperitoneal positioning as a prophylactic procedure.

trial registrationClinicalTrials.gov NCT04681326. Registered (retrospectively after first patient recruited) on 23 December 2020.

Indexed as

Abdominal WallAbdominal Wound Closure TechniquesBiological ProductsIncisional HerniaPeritonitisHumansProspective StudiesProstheses and ImplantsQuality of LifeRetrospective StudiesSurgical MeshBiological ProductsAbdominal sonographyAcute abdomenBiological meshEmergency surgeryIncisional herniaLaparotomyPeritonitisRandomized trialSwine dermal collagen prosthesis

Identifiers

PMID35246206
PMCPMC8895107
OpenAlexW4220680890

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.