Short Stitch Monomax® (Short-Stitch)

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

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).

Study Overview

• Status: Completed
• Conditions: Surgical Wound Infection; Dehiscence of Laparotomy Wound
• Intervention / Treatment: Procedure: Short Stitch

• Study Type: Observational
• Enrollment (Actual): 351

Contacts and Locations

Study Locations

• Germany
  • Schwäbisch Hall, Germany, 74523
    • Diakonie Klinikum Schwäbisch Hall gGmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

adult patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Pregnant women

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Short Stitch; 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; 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.; Other Names: MonoMax®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Diakonie-Klinikum Schwäbisch Hall gGmbH
• Collaborators: Aesculap AG
• Investigators: Principal Investigator: Markus Golling, Prof., Diakonie-Klinikum Schwäbisch Hall gGmbH

Publications and helpful links

General Publications

• Golling M, Breul V, Zielska Z et al. 6:1 Suture or Wound length ratio with the short stitch technique - a reality check on practicability and short term outcome. Sur Res J. 2022;2(2).
• Golling M, Breul V, Zielska Z, Baumann P. The 6:1 short stitch SL-WL-ratio: short term closure results of transverse and midline incisions in elective and emergency operations. Hernia. 2024 Jan 29. doi: 10.1007/s10029-023-02927-4. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): November 10, 2017
• Study Completion (Actual): December 7, 2017

Study Registration Dates

• First Submitted: August 26, 2013
• First Submitted That Met QC Criteria: September 4, 2013
• First Posted (Estimated): September 10, 2013

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: abdominal wall closure; short stitch technique
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wounds and Injuries; Surgical Wound; Surgical Wound Infection; Wound Infection
• Other Study ID Numbers: AAG-I-H-1203