Short Stitch Monomax® (Short-Stitch)

Diakonie-Klinikum Schwäbisch Hall gGmbH

Status: Completed

Conditions: Surgical Wound Infection; Dehiscence of Laparotomy Wound

Treatments: Procedure: Short Stitch

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01938222

AAG-I-H-1203

Details and patient eligibility

About

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).

Enrollment: 351 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

- Pregnant women

Trial design

351 participants in 1 patient group

Short Stitch

Description:

Short stitch suture technique (6:1) for abdominal all closure stitch interval < 0,5 cm and lateral 0,5-0,8 cm

Treatment:

Procedure: Short Stitch