Evidence map›Paper›PMID 18644124›Full record

Trial reportBMC surgery2008

A historically controlled, single-arm, multi-centre, prospective trial to evaluate the safety and efficacy of MonoMax suture material for abdominal wall closure after primary midline laparotomy. ISSAAC-Trial [NCT005725079].

Lars Fischer, Petra Baumann, Johannes Hüsing, Christoph Seidlmayer, Markus Albertsmeier, Annette Franck, Steffen Luntz, Christoph M Seiler, Hanns-Peter Knaebel

3 registry-linked trialsOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC surgery, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 33% 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.

NCT00572507 nacompletednot on this map

A Historically-controlled Single-arm Multi-center Prospective Trial to Evaluate the Safety and Efficacy of Aesculap MonoMax® Suture Material for Abdominal Wall Closure After Primary Median Laparotomy

TypeinterventionalSponsorAesculap AGRan2007 to 2009Enrolled150ConditionsPrimary Median LaparotomyArmsMonoMax®
NCT01901068 completednot on this mapstarted 2013, after this paper: background citation

A Multicentre, International, Prospective Post-market Clinical Follow-up to Evaluate MonoMax for Abdominal Wall Closure

TypeobservationalSponsorAesculap AGRan2013 to 2015Enrolled200ConditionsAbdominal Wall WoundArmsMonoMax
NCT01965249 nacompletednot on this mapstarted 2014, after this paper: background citation

Short Stitch Versus Long Stitch Suture Technique Using Monomax® for Abdominal Wall Closure After Primary Median Laparotomy. A Randomized, Controlled, Double-blinded, Multicenter, International Trial

TypeinterventionalSponsorAesculap AGRan2014 to 2024Enrolled425ConditionsInjury of Abdominal WallArmsLong stitch, Short Stitch
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
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

9 authors at 3 institutions in 1 country.

Lars FischerDepartment of General, Visceral and Transplantation Surgery, University of Heidelberg, Germany. lars.fischer@med.uni-heidelberg.de
Petra Baumann
Johannes Hüsing
Christoph Seidlmayer
Markus Albertsmeier
Annette Franck
Steffen Luntz
Christoph M Seiler
Hanns-Peter Knaebel
Heidelberg University · DEPhilipps University of Marburg · DESt. Bonifatius Hospital · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSeveral randomized controlled trials have compared different suture materials and techniques for abdominal wall closure with respect to the incidence of incisional hernias after midline laparotomy and shown that it remains, irrespective of the methods used, considerably high, ranging from 9% to 20%. The development of improved suture materials which would reduce postoperative complications may help to lower its frequency.

designThis is a historically controlled, single-arm, multi-centre, prospective trial to evaluate the safety of MonoMax suture material for abdominal wall closure in 150 patients with primary elective midline incisions. INSECT patients who underwent abdominal closure using Monoplus and PDS will serve as historical control group. The incidences of wound infections and of burst abdomen are defined as composite primary endpoints. Secondary endpoints are the frequency of incisional hernias within one year after operation and safety. To ensure adequate comparability in surgical performance and recruitment, the 4 largest centres of the INSECT-Trial will participate. After hospital discharge, the investigators will examine the enrolled patients again at 30 days and at 12 +/- 1 months after surgery.

conclusionThis historically controlled, single-arm, multi-centre, prospective ISSAAC trial aims to assess whether the use of an ultra-long-lasting absorbable monofilament suture material is safe and efficient.

trial registrationNCT005725079.

Indexed as

SuturesAbdominal WallFemaleHernia, VentralHumansLaparotomyMaleSurgical Wound InfectionSuture Techniques

Identifiers

PMID18644124
PMCPMC2492842
OpenAlexW2064226759

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.