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Clinical trial

Triclosan-antibacterial Sutures Efficacy on the Incidence of Surgical Site Infection in Clean-contaminated Wounds; Multi-center, Double Blind, Randomized Study

ID
Name
PR2019-27
Description
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
Trial arms
Trial start
2020-02-05
Estimated PCD
2023-10-10
Trial end
2024-01-30
Status
Recruiting
Phase
Early phase I
Treatment
coated vicryl plus
Coated Polyglactin 910 with Triclosan (coated vicryl plus)
Arms:
Coated Polyglactin 910 with Triclosan
Other names:
Coated Polyglactin 910 with Triclosan
Vicryl
Coated Polyglactin 910 without Triclosan (vicryl)
Arms:
Coated Polyglactin 910 without Triclosan
Other names:
Coated Polyglactin 910 without Triclosan
Size
430
Primary endpoint
Incidence of surgical site infection
30 days
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized-controlled study', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 430, 'type': 'ESTIMATED'}}
Updated at
2023-09-06

1 organization

2 products

3 indications

Organization
ClinaMygate
Product
Coated Vicryl Plus
Indication
SSIs
Indication
Wound Infection
Indication
Surgical Site Infection
Product
Vicryl