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Clinical Trials/NCT01938222
NCT01938222
Completed
Not Applicable

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

Diakonie-Klinikum Schwäbisch Hall gGmbH1 site in 1 country351 target enrollmentJanuary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dehiscence of Laparotomy Wound
Sponsor
Diakonie-Klinikum Schwäbisch Hall gGmbH
Enrollment
351
Locations
1
Primary Endpoint
Wound-infection rate until day of discharge according to CDC (Centre of Disease Control) Classification
Status
Completed
Last Updated
2 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
December 7, 2017
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Pregnant women

Outcomes

Primary Outcomes

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

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

Study Sites (1)

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