Short Stitch Monomax®

Study Overview
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Brief Summary
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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).

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

Conditions
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Dehiscence of Laparotomy Wound, Surgical Wound Infection

Intervention / Treatment
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* Procedure: Short Stitch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and older Primary elective and primary emergency laparotomy Written informed consent Exclusion Criteria: - Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Short Stitch<br>Short stitch suture technique (6:1) for abdominal all closure stitch interval < 0,5 cm and lateral 0,5-0,8 cm | Procedure: Short Stitch<br>* 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.<br>* Other names: MonoMax®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound-infection rate until day of discharge according to CDC (Centre of Disease Control) Classification |  | until discharge (ca. 10 days after operation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoperation rate due to burst abdomen until discharge |  | until discharge (ca. 10 days after operation) | 
| Wound healing complications until discharge |  | until discharge (ca. 10 days after operation) | 
| Length of postoperative hospital stay |  | until discharge (ca. 10 days after operation) | 
| Use of the suture material (tissue drag, elasticity, knot security, knot pull tensile strength, knot run-down) |  | intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abdominal wall closure, short stitch technique