We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00645684
Recruitment Status : Completed
First Posted : March 28, 2008
Last Update Posted : March 28, 2008
Sponsor:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Diseases Laparotomy Anastomosis, Surgical Absorbable, Coated Sutures Procedure: Gastrointestinal Anastomosis Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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)
Study Start Date : April 1998
Primary Completion Date : September 2001
Study Completion Date : May 2002
Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Frequency of postoperative Complications [ Time Frame: discharge, 1 month and a maximum of 3-4 months ]

Secondary Outcome Measures :
  1. handling characteristics [ Time Frame: intraoperative ]
  2. Operation time to construct the first anastomosis [ Time Frame: intraoperative ]
  3. length of hospitalization [ Time Frame: postoperative ]
  4. costs of suture material [ Time Frame: intraoperative ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 28, 2008    Key Record Dates
Last Update Posted: March 28, 2008
Last Verified: March 2008

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