Evidence map›Paper›PMID 22183105›Full record

Trial reportLangenbeck's archives of surgery2012

Evaluation of the safety and efficacy of MonoMax® suture material for abdominal wall closure after primary midline laparotomy-a controlled prospective multicentre trial: ISSAAC [NCT005725079].

Markus Albertsmeier, Christoph M Seiler, Lars Fischer, Petra Baumann, Johannes Hüsing, Christoph Seidlmayer, Annette Franck, Karl-Walter Jauch, Hanns-Peter Knaebel, Markus W Büchler

3 registry-linked trialsOpen access · hybridAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Langenbeck's archives of surgery, 2012. 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 21 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 4 pooled it
3.8field-weighted citation impact, top 7% 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

21 citing papers in PubMed, 4 syntheses or guidelines pooled it, 50 citations in OpenAlex.

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  18. The History of GalaFLEX P4HB Scaffold.Aesthetic surgery journal · 2016
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  20. [Perioperative complications of the lower gastrointestinal tract : Prevention, recognition and treatment].Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen · 2015
    Review
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 6 institutions in 2 countries.

Markus AlbertsmeierDepartment of Surgery, University of Munich, Grosshadern Campus, Marchioninistr. 15, 81377, München, Germany.
Christoph M Seiler
Lars Fischer
Petra Baumann
Johannes Hüsing
Christoph Seidlmayer
Annette Franck
Karl-Walter Jauch
Hanns-Peter Knaebel
Markus W Büchler
Heidelberg University · DEAesculap (United States) · USLudwig-Maximilians-Universität München · DEHeidelberg University · USPhilipps University of Marburg · DESt. Bonifatius Hospital · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeDifferent suture techniques and various suture materials are in use to close midline incisions after primary laparotomy. The ISSAAC study aimed to assess the safety and efficacy of the new ultra-long-term absorbable, elastic monofilament suture material MonoMax® for abdominal wall closure.

methodsThis is a single-arm, multicentre prospective study that included 150 patients undergoing a primary elective midline incision. The control group consists of 141 patients from the INSECT study who received MonoPlus® or PDS® for abdominal wall closure. The incidences of burst abdomen and wound infection until the day of discharge were defined as the primary composite endpoints. The rate of incisional hernias 1 year after surgery, the length of postoperative hospital stay and safety parameters served as secondary endpoints. The study has been registered under www.clinicaltrials.gov [NCT005725079].

resultsEleven patients in the ISSAAC study [7.3%; 95% CI = (3.9; 13.1%)] experienced wound infection or burst abdomen until the day of discharge as compared to 16 [11.3%; 95% CI = (6.6; 17.8%)] patients in the INSECT control group (p = 0.31). The length of postoperative hospital stay was comparable in both study groups. One year after surgery, incisional hernias were observed in 21 ISSAAC patients (14.0%) in contrast to 30 hernias (21.3%) in the INSECT control group.

conclusionsThe ultra-long-term absorbable, elastic monofilament suture material MonoMax® is safe and efficient for abdominal wall closure.

Indexed as

SuturesAbdominal Wound Closure TechniquesAgedEquipment DesignFemaleHernia, AbdominalHumansIntention to Treat AnalysisLaparotomyLength of StayLogistic ModelsMaleMiddle AgedProspective StudiesReoperationSurgical Wound Infection

Identifiers

PMID22183105
PMCPMC3281202
OpenAlexW2011257537

What OpenQuestion holds

Textmetadata
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.