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

Sponsor

Aesculap AG (Industry)

Overall Status

Completed

CT.gov ID

NCT00645684

Collaborator

(none)

210

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

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

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 :

Apr 1, 1998

Actual Primary Completion Date :

Sep 1, 2001

Actual Study Completion Date :

May 1, 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.

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

Frequency of postoperative Complications [discharge, 1 month and a maximum of 3-4 months]

Secondary Outcome Measures

handling characteristics [intraoperative]
Operation time to construct the first anastomosis [intraoperative]
length of hospitalization [postoperative]
costs of suture material [intraoperative]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country
1	Bugat Pal Korhaz, Sebeszeti Osztaly	Gyöngyös	Hungary
2	B.-A.-Z. Megyei Korhaz, Sebeszeti Osztaly	Miskolc	Hungary
3	Medical School of University Pecs	Pecs	Hungary