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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

912 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-05

Study Completion Date

2022-04-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Laparoscopic Surgery Surgical Wound Surgical Site Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized-controlled

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Coated Polyglactin 910 with Triclosan

Group Type EXPERIMENTAL

Coated Vicryl plus

Intervention Type DRUG

Vicryl plus (Coated Polyglactin 910 with Triclosan)

Coated Polyglactin 910 without Triclosan

Group Type ACTIVE_COMPARATOR

Coated vicryl

Intervention Type DRUG

Vicryl (Coated Polyglactin 910 without Triclosan)

Interventions

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Coated Vicryl plus

Vicryl plus (Coated Polyglactin 910 with Triclosan)

Intervention Type DRUG

Coated vicryl

Vicryl (Coated Polyglactin 910 without Triclosan)

Intervention Type DRUG

Other Intervention Names

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Coated Polyglactin 910 with Triclosan Coated Polyglactin 910 without Triclosan

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No