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

NCT04256824 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: PR2019-27
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

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

Conditions

Surgical Site Infection; Surgical Wound; Surgical Wound Infection

Outcome Measures

Primary Outcomes (1)

• Incidence of surgical site infection

  Incidence of surgical site infection within 30 days

  30 days

Secondary Outcomes (1)

• Hospital stay

  30 days

Study Arms (2)

Coated Polyglactin 910 with Triclosan

EXPERIMENTAL

Coated vicryl plus

Drug: coated vicryl plus

Coated Polyglactin 910 without Triclosan

ACTIVE COMPARATOR

Coated vicryl

Drug: Vicryl

Interventions

coated vicryl plus DRUG

Coated Polyglactin 910 with Triclosan (coated vicryl plus)

Also known as: Coated Polyglactin 910 with Triclosan

Coated Polyglactin 910 with Triclosan

Vicryl DRUG

Coated Polyglactin 910 without Triclosan (vicryl)

Also known as: Coated Polyglactin 910 without Triclosan

Coated Polyglactin 910 without Triclosan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ClinAmygate: lead
• Misr University for Science and Technology: collaborator
• Al Safwa Hospital: collaborator
• Al Zohour Hospital: collaborator
• Al-Menia Univeristy Hospital: collaborator
• MSKMC Univeristy Hospital: collaborator

Study Sites (1)

Misr Univeristy for Science and Technology Hospital

Giza, Egypt

RECRUITING

Related Publications (1)

• 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.

  PMID: 31481559 RESULT

MeSH Terms

Conditions

Surgical Wound Infection; Surgical Wound

Interventions

Triclosan; Polyglactin 910

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polyesters; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Emad R Issak, Diploma

  ClinAmygate

  STUDY DIRECTOR

Central Study Contacts

Emad R Issak, Diploma

CONTACT

00201272228989; dr.emad.r.h.issak@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized-controlled study

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 5, 2020
• Study Start: February 5, 2020
• Primary Completion: October 10, 2023
• Study Completion: January 30, 2024
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)