NCT01938222

Short Stitch Monomax®

A Prospective, Controlled Monocentric Study Evaluating the 6:1 Suture Technique Using Suture Material Monomax® for Abdominal Wall Closure After Primary Abdominal Incision

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 351 (actual)
• Sponsor: Diakonie-Klinikum Schwäbisch Hall gGmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A number of studies identifies abdominal hernia as the most frequent postoperative complication following laparotomy with percentages of 9-20% - depending on duration of follow-up. It is based on a multifactorial basis, including factors concerning individual, patient-specific factors, factors related to the operational technique as well as particular surgical factors. Wound complications have been reported by 7-12%, burst abdomen rate (dehiscence) \< 5 days being 2-4%, wound infection rate (+/- wound dehiscence) ≥ 5 days being 6-10%. In emergency procedures (e.g. ileus, perforation of hollow organ) a wound complication rate of up to 50 % has to be expected. According to new, first findings from recent studies the rates of wound healing complication and burst abdomen can be reduced significantly. Depending on the study, to almost 50%. The principle is based on the reduction of the stitch length and type of the inserted suture. The stitches are closer and with less distance to the edge of fascia. Due to the much thinner suture it still comes here to a quantitative reduction of the inserted suture. The data collected using the MonoMax® suture in the short stitch technique will be compared to the results of the ISSAAC trial, in which the MonoMax® suture was used in the long stitch suture technique. The generated data are thus subject of retrospective comparison with a historical control group (ISSAAC study).

Conditions

• Dehiscence of Laparotomy Wound
• Surgical Wound Infection

Interventions

Type	Name	Description
PROCEDURE	Short Stitch	MonoMax® suture material USP (United States Pharmacopeia) 2/0, 150 cm, HR (half-round) 26 mm needle, will be applied in the short stitch technique (6:1) for abdominal wall closure.

Timeline

• Start date: 2013-01-01
• Primary completion: 2017-11-10
• Completion: 2017-12-07
• First posted: 2013-09-10
• Last updated: 2024-03-07

Locations

1 site across 1 country: Germany