Short Stitch Monomax®

Surgical Wound Infection Clinical Trial

— Short-Stitch  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01938222
• Other study ID #: AAG-I-H-1203
• Status: Completed
• Start date: January 2013
• Est. completion date: December 7, 2017

Study information

• Verified date: March 2024
• Source: Diakonie-Klinikum Schwäbisch Hall gGmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: December 7, 2017
• Est. primary completion date: November 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant women

Related Conditions & MeSH terms

• Dehiscence of Laparotomy Wound
• Surgical Wound
• Surgical Wound Infection
• Wound Infection
• Wounds and Injuries

Intervention

Procedure:
• Short 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.

Locations

Country	Name	City	State
Germany	Diakonie Klinikum Schwäbisch Hall gGmbH	Schwäbisch Hall

Sponsors (2)

Lead Sponsor	Collaborator
Diakonie-Klinikum Schwäbisch Hall gGmbH	Aesculap AG

Country where clinical trial is conducted

Germany, 

References & 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).

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 Jan 29. doi: 10.1007/s10029-023-02927-4. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound-infection rate until day of discharge according to CDC (Centre of Disease Control) Classification		until discharge (ca. 10 days after operation)
Secondary	Reoperation rate due to burst abdomen until discharge		until discharge (ca. 10 days after operation)
Secondary	Wound healing complications until discharge		until discharge (ca. 10 days after operation)
Secondary	Length of postoperative hospital stay		until discharge (ca. 10 days after operation)
Secondary	Use of the suture material (tissue drag, elasticity, knot security, knot pull tensile strength, knot run-down)		intraoperative