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

This study has been completed.
Sponsor:
Information provided by:
Aesculap AG
ClinicalTrials.gov Identifier:
NCT00645684
First received: March 25, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Gastrointestinal Diseases
Laparotomy
Anastomosis, Surgical
Absorbable, Coated Sutures
Procedure: Gastrointestinal Anastomosis
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Clinical Use of an Absorbable Coated Suture Material in Surgery (Safil) One Layer Running(A) vs. Two-Layer Suture Technique (B)

Resource links provided by NLM:


Further study details as provided by Aesculap AG:

Primary Outcome Measures:
  • Frequency of postoperative Complications [ Time Frame: discharge, 1 month and a maximum of 3-4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • handling characteristics [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
  • Operation time to construct the first anastomosis [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
  • length of hospitalization [ Time Frame: postoperative ] [ Designated as safety issue: No ]
  • costs of suture material [ Time Frame: intraoperative ] [ Designated as safety issue: No ]

Enrollment: 210
Study Start Date: April 1998
Study Completion Date: May 2002
Primary Completion Date: September 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
one layer running suture technique
Procedure: Gastrointestinal Anastomosis
Gastrointestinal Anastomosis with synthetic, absorbable, coated suture material using two different suture-techniques
Other Names:
  • SAFIL®: is a mid-term braided and coated synthetic absorbable suture made of
  • pure polyglycolic acid.
Experimental: B
two-layer suture technique
Procedure: Gastrointestinal Anastomosis
Gastrointestinal Anastomosis with synthetic, absorbable, coated suture material using two different suture-techniques
Other Names:
  • SAFIL®: is a mid-term braided and coated synthetic absorbable suture made of
  • pure polyglycolic acid.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of both sexes, undergoing a gastrointestinal hand made one-layer running (A) or two-layer (B) anastomotic procedure where the use of synthetic absorbable surgical suture material is indicated.
  • Written consent to participate in the study

Exclusion Criteria:

  • Emergency patients that cannot be properly informed about the clinical trial and cannot give their written consent
  • Pregnancy or lactation period
  • Patients suffering from a diffuse purulent peritonitis or generalized diseases, which can have consequences for the healing of the asnastomosis (e.g. ubalanced diabetes, progressed uremia, massive hypoproteinaemia, sever jaundice, generalized intraabdominal tumor metastases, severe tumorous cachexia, severe avitaminosis, chronic liver disease.
  • Patients who are undergoing a therapeutic procedure, which can have consequences for the healing of the anastomosis (e.g. treatment with corticosteroids or cytostatics, local radiation in the operating area)
  • Laparoscopial Procedures
  • Patients who are not willing to cooperate and legally incapacitated people
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645684

Locations
Hungary
Bugat Pal Korhaz, Sebeszeti Osztaly
Gyöngyös, Hungary
B.-A.-Z. Megyei Korhaz, Sebeszeti Osztaly
Miskolc, Hungary
Medical School of University Pecs
Pecs, Hungary
Sponsors and Collaborators
Aesculap AG
Investigators
Principal Investigator: György Weber, MD, PhD Medical School of University Pecs, Hungary
  More Information

No publications provided

Responsible Party: Dr. Erich Odermatt, Aesculap AG&Co. KG, 78532 Tuttlingen, Germany
ClinicalTrials.gov Identifier: NCT00645684     History of Changes
Other Study ID Numbers: BBS-WV-H-0219
Study First Received: March 25, 2008
Last Updated: March 25, 2008
Health Authority: Hungary: Regional Research Ethics Committee of Pote

Keywords provided by Aesculap AG:
Gastrointestinal Anastomosis
Multicentre
Randomized controlled single-blind study
synthetic, absorbable, braided and coated suture material
Laparotomy

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2014