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Open Access Study protocol

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 Fischer1, Petra Baumann2, Johannes Hüsing3, Christoph Seidlmayer4, Markus Albertsmeier5, Annette Franck6, Steffen Luntz3, Christoph M Seiler1 and Hanns-Peter Knaebel2*

Author affiliations

1 Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Germany

2 Aesculap AG, Am Aesculap Platz, Tuttlingen, Germany

3 KKS, University of Heidelberg, Germany

4 Department of Visceral Surgery, St. Bonifatius-Hospital Lingen, Germany

5 Department of Surgery, University Munich-Großhadern, Germany

6 Department of Visceral, Thoracic and Vascular Surgery, Philipps University, Marburg, Germany

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Citation and License

BMC Surgery 2008, 8:12  doi:10.1186/1471-2482-8-12

Published: 21 July 2008

Abstract

Background

Several 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.

Design

This 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.

Conclusion

This 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 registration

NCT005725079