Clinical trial NCT01938222: Short Stitch Monomax®
Official title: A Prospective, Controlled Monocentric Study Evaluating the 6:1 Suture Technique Using Suture Material Monomax® for Abdominal Wall Closure After Primary Abdominal Incision
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dehiscence of Laparotomy Wound
Surgical Wound Infection
Keywords: abdominal wall closure
short stitch technique
Lead sponsor: Diakonie-Klinikum Schwäbisch Hall gGmbH
Sponsor class: OTHER
Collaborators: name: Aesculap AG
First posted: 2013-09-10
Enrollment: 351
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients

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).


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

- Pregnant women

Primary outcomes:
measure: Wound-infection rate until day of discharge according to CDC (Centre of Disease Control) Classification
timeFrame: until discharge (ca. 10 days after operation)
Secondary outcomes:
measure: Reoperation rate due to burst abdomen until discharge
timeFrame: until discharge (ca. 10 days after operation)
measure: Wound healing complications until discharge
timeFrame: until discharge (ca. 10 days after operation)
measure: Length of postoperative hospital stay
timeFrame: until discharge (ca. 10 days after operation)
measure: Use of the suture material (tissue drag, elasticity, knot security, knot pull tensile strength, knot run-down)
timeFrame: intraoperative
Other outcomes:
Locations:
city: Schwäbisch Hall
country: Germany
facility: Diakonie Klinikum Schwäbisch Hall gGmbH
Study officials:
affiliation: Diakonie-Klinikum Schwäbisch Hall gGmbH
name: Markus Golling, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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).
citation: 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.