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

NCT ID: NCT00645684

Last Updated: 2008-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-04-30

Study Completion Date

2002-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastrointestinal Diseases Laparotomy Anastomosis, Surgical Absorbable, Coated Sutures

Keywords

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Gastrointestinal Anastomosis Multicentre Randomized controlled single-blind study synthetic, absorbable, braided and coated suture material Laparotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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A

one layer running suture technique

Group Type EXPERIMENTAL

Gastrointestinal Anastomosis

Intervention Type PROCEDURE

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

B

two-layer suture technique

Group Type EXPERIMENTAL

Gastrointestinal Anastomosis

Intervention Type PROCEDURE

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

Interventions

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Gastrointestinal Anastomosis

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

Intervention Type PROCEDURE

Other Intervention Names

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SAFIL®: is a mid-term braided and coated synthetic absorbable suture made of pure polyglycolic acid.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aesculap AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Aesculap AG&Co. KG, 78532 Tuttlingen, Germany

Principal Investigators

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György Weber, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical School of University Pecs, Hungary

Locations

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Bugat Pal Korhaz, Sebeszeti Osztaly

Gyöngyös, , Hungary

Site Status

B.-A.-Z. Megyei Korhaz, Sebeszeti Osztaly

Miskolc, , Hungary

Site Status

Medical School of University Pecs

Pécs, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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BBS-WV-H-0219

Identifier Type: -

Identifier Source: org_study_id