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

Sponsor

ClinAmygate (Other)

Overall Status

Recruiting

CT.gov ID

NCT04256824

Collaborator

Misr University for Science and Technology (Other), Al Safwa Hospital (Other), Al Zohour Hospital (Other), Al-Menia Univeristy Hospital (Other), MSKMC Univeristy Hospital (Other)

430

Enrollment

Location

Arms

30.3

Anticipated Duration (Months)

14.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Surgical Site Infection Surgical Wound Surgical Wound Infection	Drug: coated vicryl plus Drug: Vicryl	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

430 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomized-controlled studyrandomized-controlled study

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 5, 2020

Anticipated Primary Completion Date :

Jun 10, 2022

Anticipated Study Completion Date :

Aug 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Coated Polyglactin 910 with Triclosan Coated vicryl plus	Drug: coated vicryl plus Coated Polyglactin 910 with Triclosan (coated vicryl plus) Other Names: Coated Polyglactin 910 with Triclosan
Active Comparator: Coated Polyglactin 910 without Triclosan Coated vicryl	Drug: Vicryl Coated Polyglactin 910 without Triclosan (vicryl) Other Names: Coated Polyglactin 910 without Triclosan

Arm

Intervention/Treatment

Experimental: Coated Polyglactin 910 with Triclosan

Coated vicryl plus

Drug: coated vicryl plus

Coated Polyglactin 910 with Triclosan (coated vicryl plus)

Other Names:

Coated Polyglactin 910 with Triclosan

Active Comparator: Coated Polyglactin 910 without Triclosan

Coated vicryl

Drug: Vicryl

Coated Polyglactin 910 without Triclosan (vicryl)

Other Names:

Coated Polyglactin 910 without Triclosan

Outcome Measures

Primary Outcome Measures

Incidence of surgical site infection [30 days]
Incidence of surgical site infection within 30 days

Secondary Outcome Measures

Hospital stay [30 days]
duration of hospital stay

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.