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].
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.


METHODS
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.


CONCLUSIONS
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.


BACKGROUND
NCT005725079.
Fischer
Lars
L
Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Germany. lars.fischer@med.uni-heidelberg.de
Baumann
Petra
P
Hüsing
Johannes
J
Seidlmayer
Christoph
C
Albertsmeier
Markus
M
Franck
Annette
A
Luntz
Steffen
S
Seiler
Christoph M
CM
Knaebel
Hanns-Peter
HP
D034861:Abdominal Wall / Q000601:surgery*; D005260:Female; D006555:Hernia, Ventral / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D007813:Laparotomy / Q000009:adverse effects*; D008297:Male; D013530:Surgical Wound Infection / Q000209:etiology / Q000517:prevention & control*; D013536:Suture Techniques; D013537:Sutures