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]

Incisional Hernia Clinical endpoint
DOI: 10.1007/s00423-011-0884-6 Publication Date: 2011-12-19T19:38:54Z
ABSTRACT
Different suture techniques and various materials are in use to close midline incisions after primary laparotomy. The ISSAAC study aimed assess the safety efficacy of new ultra-long-term absorbable, elastic monofilament material MonoMax® for abdominal wall closure. This is a single-arm, multicentre prospective that included 150 patients undergoing elective incision. control group consists 141 from INSECT who received MonoPlus® or PDS® incidences burst abdomen wound infection until day discharge were defined as composite endpoints. rate incisional hernias 1 year surgery, length postoperative hospital stay parameters served secondary has been registered under www.clinicaltrials.gov [NCT005725079]. Eleven [7.3%; 95% CI = (3.9; 13.1%)] experienced compared 16 [11.3%; (6.6; 17.8%)] (p 0.31). was comparable both groups. One observed 21 (14.0%) contrast 30 (21.3%) group. safe efficient
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