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].

PURPOSE: Different 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. METHODS: This 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]. RESULTS: Eleven 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. CONCLUSIONS: The ultra-long-term absorbable, elastic monofilament suture material MonoMax® is safe and efficient for abdominal wall closure.

Interrupted or continuous slowly absorbable sutures for closure of primary elective midline abdominal incisions: a multicenter randomized trial (INSECT: ISRCTN24023541).

OBJECTIVE: In patients undergoing midline incisions, the abdominal fascia can be closed with a continuous or interrupted suture using various materials. The aim of this study is to compare: (1) interrupted technique with rapidly absorbable sutures and (2) continuous techniques with different slowly absorbable sutures, focusing on the incidence of incisional hernias within 1 year. SUMMARY OF BACKGROUND DATA: A meta-analysis suggested that the incidence of incisional hernias can be more effectively reduced with slowly absorbable continuous sutures. METHODS: Multicenter randomized surgical trial with 3 parallel groups. Patients were scheduled for primary elective midline incisions. All surgeons were trained (4:1 suture wound length in continuous groups) and monitored. Primary end point, measured within 1 year after surgery, was the frequency of incisional hernias diagnosed by clinical examination and confirmed by ultrasound. Complications and safety were used as secondary end points. This study has been registered with the ISRCTN Register (INSECT: ISRCTN24023541). RESULTS: Conducted on 625 randomized patients (210 interrupted Vicryl, 205 continuous polydioxanone suture (PDS), 210 continuous Monoplus), the primary analysis showed an incidence of 28 incisional hernias (15.9%) versus 15 (8.4%) versus 22 (12.5%) for the 3 closure techniques, respectively (P = 0.09). No significant difference was observed between the 3 groups with regard to burst abdomen (4 [2.0%] vs. 6 [3.0%] vs. 8 [4.0%], P = 0.46), wound infection (26 [12.7%] vs. 39 [19.4%] vs. 33 [16.3%], P = 0.19), pulmonary infections (9 [4.4%] vs. 5 [2.5%] vs. 5 [2.5%], P = 0.46), serious adverse events (63 [30.0%] vs. 57 [27.8%] vs. 61 [29.1%], P = 0.89), and 1-year mortality (16 [7.9%] vs. 11 [5.5%] vs. 16 [7.9%], P = 0.54). CONCLUSIONS: The incidence of incisional hernias and the frequency of wound infection was higher than expected in all groups. New concepts need to be developed and studied to substantially reduce the frequency of incisional hernias.

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. 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.