Short Stitch Monomax®

Completed

• Conditions: Dehiscence of Laparotomy Wound; Surgical Wound Infection
• Interventions: Procedure: Short Stitch

• Registration Number: NCT01938222
• Lead Sponsor: Diakonie-Klinikum Schwäbisch Hall gGmbH

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-08-26
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-10
• Primary Completion: 2017-11-10
• Study Completion: 2017-12-07
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 351

Inclusion Criteria

• Age 18 years and older
• Primary elective and primary emergency laparotomy
• Written informed consent

Exclusion Criteria

• Pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Short Stitch	Short Stitch	Short stitch suture technique (6:1) for abdominal all closure stitch interval \< 0,5 cm and lateral 0,5-0,8 cm

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Use of the suture material (tissue drag, elasticity, knot security, knot pull tensile strength, knot run-down)	intraoperative
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)

Trial Locations

Locations (1)

Diakonie Klinikum Schwäbisch Hall gGmbH; 🇩🇪 Schwäbisch Hall, Germany