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Completed

NCT Number: NCT01938222

Short Stitch Monomax®

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Diakonie Klinikum Schwäbisch Hall gGmbH

Schwäbisch Hall, 74523, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnant women

Treatment and study plan

Short stitch

Procedure

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®

Primary outcomes

  1. Wound-infection rate until day of discharge according to CDC (Centre of Disease Control) Classification

    Time frame: until discharge (ca. 10 days after operation)

Secondary outcomes

  1. Reoperation rate due to burst abdomen until discharge

    Time frame: until discharge (ca. 10 days after operation)

  2. Wound healing complications until discharge

    Time frame: until discharge (ca. 10 days after operation)

  3. Length of postoperative hospital stay

    Time frame: until discharge (ca. 10 days after operation)

  4. Use of the suture material (tissue drag, elasticity, knot security, knot pull tensile strength, knot run-down)

    Time frame: intraoperative

Sponsors and collaborators

Lead sponsor

Diakonie-Klinikum Schwäbisch Hall gGmbH

Other

Collaborators

  • Aesculap AG

Registry information

Official study title

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

Acronym: Short-Stitch

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 10, 2013
Registry last updated
Mar 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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