Multi-center Study to Evaluate the Safety and Efficacy of Aesculap MonoMax® for Abdominal Wall Closure

Conditions

Primary Median Laparotomy

Keywords

Absorbable Monofilament Suture Material, Safety and Efficacy, Abdominal Wall/ Fascia, Laparotomy

Brief summary

MonoMax will be used for a continuous all-layer (except skin) suture to close abdominal wall after midline incision. The primary objective of this trial is to demonstrate that the frequency of wound infection and the frequency of reoperation due to burst-abdomen after primary median laparotomy for elective surgical intervention are equal or lower than in the INSECT trial. The secondary objectives are to demonstrate that the length of postoperative hospital stay and the frequency of abdominal hernias 12 months after the surgery are equal or lower than in the INSECT trial. \[Knaebel HP et al., 2005\]

René H. Fortelny, Anna Hofmann, Petra Baumann, Stefan Riedl, Jan Ludolf Kewer et al. (14 authors)

Hernia2024-03-279 citations

10.1007/s10029-024-03025-9

Continuous and interrupted abdominal-wall closure after primary emergency midline laparotomy (CONIAC-trial): study protocol for a randomised controlled single centre trial

Sebastian Wolf, Luis Arbona de Gracia, Florian Sommer, M. Schrempf, Matthias Anthuber et al. (6 authors)

BMJ Open2022-11-014 citations

10.1136/bmjopen-2021-059709

Effects of the short stitch technique for midline abdominal closure on incisional hernia (ESTOIH): randomized clinical trial

René H. Fortelny, Dorian Andrade, Malte Schirren, Petra Baumann, Stefan Riedl et al. (16 authors)

British journal of surgery2022-06-1632 citations

10.1093/bjs/znac194

Abdominal incision defect following AAA-surgery (AIDA): 2-year results of prophylactic onlay-mesh augmentation in a multicentre, double-blind, randomised controlled trial.

Honig S, Diener H, Kölbel T, Reinpold W, Zapf A, Bibiza-Freiwald E, Debus ES, for AIDA study group.

2021-07-2113 citations

10.1007/s13304-021-01125-0

Effects of the short-stitch technique for midline abdominal closure: short-term results from the randomised-controlled ESTOIH trial

Markus Albertsmeier, Anna Hofmann, Petra Baumann, Stefan Riedl, Claudia Reisensohn et al. (15 authors)

Hernia2021-05-2846 citations

10.1007/s10029-021-02410-y

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].

Albertsmeier M, Seiler CM, Fischer L, Baumann P, Hüsing J, Seidlmayer C, Franck A, Jauch KW, Knaebel HP, Büchler MW.

2011-12-2034 citations

10.1007/s00423-011-0884-6

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].

Fischer L, Baumann P, Hüsing J, Seidlmayer C, Albertsmeier M, Franck A, Luntz S, Seiler CM, Knaebel HP.

2008-07-213 citations

10.1186/1471-2482-8-12

Interventions

DEVICEMonoMax®

Abdominal wall closure with ultra-longterm absorbable monofilament suture after primary median laparotomy

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Age equal or greater than 18 years * Expected survival time \> 12 months * Patient undergoing elective and primary median laparotomy * BMI \< 35 * Expected length of skin incision \> 15 cm

Exclusion criteria

* Peritonitis * Emergency surgery * Coagulopathy * Current immunosuppressive therapy (\> 40 mg of a Corticoid per day or Azathioprin) * Chemotherapy within 2 weeks before operation * Radiotherapy of the abdomen completed less than 8 weeks before operation

Design outcomes

Primary

Measure	Time frame
frequency of wound infection, frequency of reoperation due to burst-abdomen after primary median laparotomy	till day of discharge

Secondary

Measure	Time frame
length of postoperative hospital stay after surgery and frequency of incisional hernias 12 months after the surgery and frequency of wound infections 30 days postoperative	different

Countries

Germany

Outcome results

None listed