NCT00645684

Clinical Use of an Absorbable Coated Suture Material in Surgery (Safil)

Clinical Use of an Absorbable Coated Suture Material in Surgery (Safil) One Layer Running(A) vs. Two-Layer Suture Technique (B)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose is to test a coated polyglycolic acid multifilament suture in gastrointestinal surgery as part of a controlled randomized single blinded parallel group trial. The applicability and safety of the strand material used in two suture techniques (2-layer suture technique vs. 1-layer running) are to be tested on the basis of handling characteristics, the operative time consumed for the construction of the 1st anastomosis, the average time of the hospital duration for both patient groups, and the frequency of postoperative complications after discharge, 1 month and a maximum of 3-4 months. The used suture units are counted and the length of sutures determined which will be an indirect measurement of the costs of suture material for the two techniques.

Conditions

• Gastrointestinal Diseases
• Laparotomy
• Anastomosis, Surgical
• Absorbable, Coated Sutures

Interventions

Type	Name	Description
PROCEDURE	Gastrointestinal Anastomosis	Gastrointestinal Anastomosis with synthetic, absorbable, coated suture material using two different suture-techniques

Timeline

• Start date: 1998-04-01
• Primary completion: 2001-09-01
• Completion: 2002-05-01
• First posted: 2008-03-28
• Last updated: 2008-03-28

Locations

3 sites across 1 country: Hungary