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

NCT00645684 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2008-03-28

No results posted yet for this study

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

PROCEDURE

Gastrointestinal Anastomosis

Gastrointestinal Anastomosis with synthetic, absorbable, coated suture material using two different suture-techniques

Sponsors & Collaborators

  • Aesculap AG

    lead INDUSTRY

Principal Investigators

  • György Weber, MD, PhD · Medical School of University Pecs, Hungary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-04-30
Primary Completion
2001-09-30
Completion
2002-05-31

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00645684 on ClinicalTrials.gov