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Short Stitch Monomax®

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01938222
Acronym
Short-Stitch
Enrollment
351
Registered
2013-09-10
Start date
2013-01-31
Completion date
2017-12-07
Last updated
2024-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dehiscence of Laparotomy Wound, Surgical Wound Infection

Keywords

abdominal wall closure, short stitch technique

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).

Interventions

PROCEDUREShort 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.

Sponsors

Aesculap AG
CollaboratorINDUSTRY
Diakonie-Klinikum Schwäbisch Hall gGmbH
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

\- Pregnant women

Design outcomes

Primary

MeasureTime frame
Wound-infection rate until day of discharge according to CDC (Centre of Disease Control) Classificationuntil discharge (ca. 10 days after operation)

Secondary

MeasureTime frame
Reoperation rate due to burst abdomen until dischargeuntil discharge (ca. 10 days after operation)
Wound healing complications until dischargeuntil discharge (ca. 10 days after operation)
Length of postoperative hospital stayuntil discharge (ca. 10 days after operation)
Use of the suture material (tissue drag, elasticity, knot security, knot pull tensile strength, knot run-down)intraoperative

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026