Short Stitch Monomax®

NCT01938222 | Completed

• 1 other identifier: AAG-I-H-1203
• Study Type: observational
• Target: 351
• Locations: 1 country
• Sites: 1

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).

Conditions

Dehiscence of Laparotomy Wound; Surgical Wound Infection

Keywords

abdominal wall closure; short stitch technique

Outcome Measures

Primary Outcomes (1)

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

  until discharge (ca. 10 days after operation)

Secondary Outcomes (4)

• 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

Study Arms (1)

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

Interventions

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.

Also known as: MonoMax®

Short Stitch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients

You may qualify if:

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

You may not qualify if:

• \- Pregnant women

Sponsors & Collaborators

• Diakonie-Klinikum Schwäbisch Hall gGmbH: lead
• Aesculap AG: collaborator

Study Sites (1)

Diakonie Klinikum Schwäbisch Hall gGmbH

Schwäbisch Hall, 74523, Germany

Location

Related Publications (2)

• 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).

  BACKGROUND

• 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 Apr;28(2):447-456. doi: 10.1007/s10029-023-02927-4. Epub 2024 Jan 29.

  PMID: 38285168 RESULT

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Markus Golling, Prof.

  Diakonie-Klinikum Schwäbisch Hall gGmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2013
• First Posted: September 10, 2013
• Study Start: January 1, 2013
• Primary Completion: November 10, 2017
• Study Completion: December 7, 2017
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

DE (1)