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

NCT ID: NCT04256824

Last Updated: 2023-09-06

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

430 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-05

Study Completion Date

2024-01-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Surgical Site Infection Surgical Wound Surgical Wound Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized-controlled study
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Coated Polyglactin 910 with Triclosan

Coated vicryl plus

Group Type EXPERIMENTAL

coated vicryl plus

Intervention Type DRUG

Coated Polyglactin 910 with Triclosan (coated vicryl plus)

Coated Polyglactin 910 without Triclosan

Coated vicryl

Group Type ACTIVE_COMPARATOR

Vicryl

Intervention Type DRUG

Coated Polyglactin 910 without Triclosan (vicryl)

Interventions

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coated vicryl plus

Coated Polyglactin 910 with Triclosan (coated vicryl plus)

Intervention Type DRUG

Vicryl

Coated Polyglactin 910 without Triclosan (vicryl)

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
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Misr University for Science and Technology

OTHER

Sponsor Role collaborator

Al Safwa Hospital

UNKNOWN

Sponsor Role collaborator

Al Zohour Hospital

UNKNOWN

Sponsor Role collaborator

Al-Menia Univeristy Hospital

UNKNOWN

Sponsor Role collaborator

MSKMC Univeristy Hospital

UNKNOWN

Sponsor Role collaborator

ClinAmygate

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emad R Issak, Diploma

Role: STUDY_DIRECTOR

ClinAmygate

Locations

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Misr Univeristy for Science and Technology Hospital

Giza, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Emad R Issak, Diploma

Role: CONTACT

00201272228989

Facility Contacts

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Moatasem-Bellah A Erfaan, MD

Role: primary

01223478555

References

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Ahmed I, Boulton AJ, Rizvi S, Carlos W, Dickenson E, Smith NA, Reed M. The use of triclosan-coated sutures to prevent surgical site infections: a systematic review and meta-analysis of the literature. BMJ Open. 2019 Sep 3;9(9):e029727. doi: 10.1136/bmjopen-2019-029727.

Reference Type RESULT
PMID: 31481559 (View on PubMed)

Other Identifiers

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PR2019-27

Identifier Type: -

Identifier Source: org_study_id

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