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Triclosan-antibacterial Sutures Impact on the Incidence of Surgical Site Infection in Laparoscopic Surgeries.

C

ClinAmygate

Status and phase

Completed
Phase 4

Conditions

Laparoscopic Surgery
Surgical Site Infection
Surgical Wound

Treatments

Drug: Coated Vicryl plus
Drug: Coated vicryl

Study type

Interventional

Funder types

Other

Identifiers

NCT04255927
PR2019-26

Details and patient eligibility

About

Comparing the incidence of PSI in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in laparoscopic sleeve gastrectomy, laparoscopic appendectomy or laparoscopic cholecystectomy.

Full description

In this prospective study, we will determine the incidence of PSI in Egypt as well as the impact of using coated polyglactin 910 sutures with Triclosan in lowering the incidence of PSI in laparoscopic sleeve gastrectomy, laparoscopic appendectomy or laparoscopic cholecystectomy.

Enrollment

912 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • age 18-75
  • candidate for laparoscopic surgical intervention during the period of the study were included.

Exclusion criteria

  • Patient has immunodeficiency disorder.
  • Patient receiving anti-cancer / immunosuppressive therapy.
  • Patients with established pre-operative infection whether community acquired or hospital acquired either at / remote from the operative site.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

912 participants in 2 patient groups

Coated Polyglactin 910 with Triclosan
Experimental group
Description:
Coated Polyglactin 910 with Triclosan
Treatment:
Drug: Coated Vicryl plus
Coated Polyglactin 910 without Triclosan
Active Comparator group
Description:
Coated Polyglactin 910 without Triclosan
Treatment:
Drug: Coated vicryl

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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