Triclosan-antibacterial Sutures Efficacy on the Incidence of Surgical Site Infection in Clean-contaminated Wounds

ClinAmygate

Status and phase: Enrolling; Phase 4

Conditions: Surgical Wound; Surgical Site Infection; Surgical Wound Infection

Treatments: Drug: coated vicryl plus; Drug: Vicryl

Study type: Interventional

Funder types: Other

Identifiers

NCT04256824

PR2019-27

Details and patient eligibility

About

Comparing the incidence of SSI in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in clean-contaminated wound surgery

Full description

Comparing the incidence of surgical site infection (SSI) in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in clean-contaminated wound surgery. Also, comparing the post hospital stay.

Enrollment: 430 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age: 18-75
• clean-contaminated wound surgery

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: Double Blind

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430 participants in 2 patient groups

Coated Polyglactin 910 with Triclosan

Experimental group

Description:

Coated vicryl plus

Treatment:

Drug: coated vicryl plus

Coated Polyglactin 910 without Triclosan

Active Comparator group

Description:

Coated vicryl

Treatment:

Drug: Vicryl