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Completed

NCT Number: NCT00645684

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

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.

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Key information

Conditions

Gastrointestinal Diseases Absorbable, Coated Sutures Anastomosis, Surgical Digestive System Diseases Laparotomy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bugat Pal Korhaz, Sebeszeti Osztaly, Gyöngyös, Hungary

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gastrointestinal Anastomosis

Procedure

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.

Primary outcomes

  1. Frequency of postoperative Complications

    Time frame: discharge, 1 month and a maximum of 3-4 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study title

Clinical Use of an Absorbable Coated Suture Material in Surgery (Safil) One Layer Running(A) vs. Two-Layer Suture Technique (B)

Important dates

Study start
1998
Primary completion
2001
Study completion
2002
First posted
Mar 28, 2008
Registry last updated
Mar 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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