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RecruitingNCT04256824Updated Sep 6, 2023

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

A Phase 4 interventional study of coated vicryl plus and Vicryl in Surgical Site Infection, Surgical Wound and Surgical Wound Infection, sponsored by ClinAmygate. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-09-06.

Sponsored by ClinAmygate · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Oct 2023, 3 years 1 month ago, but the record still lists the study as recruiting.
  • Started Feb 2020; still recruiting 6 years 9 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
430
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Surgical Site Infection
  • Surgical Wound
  • Surgical Wound Infection
03

In context

Surgical Wound Infection

745 studies on the registry are indexed under Surgical Wound Infection; 151 are open to participants now.

This study's planned enrollment of 430 is above the median of 200 across 581 interventional studies indexed under Surgical Wound Infection.

Browse Surgical Wound Infection studies →

Lead sponsor

ClinAmygate is the lead sponsor of 18 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patient has immunodeficiency disorder.
  • Patient receiving anti-cancer / therapy.
  • Patients with established pre-operative infection whether community acquired or hospital acquired either at / remote from the operative site.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
430 participants (estimated)

Study arms

  • Experimental
    Coated Polyglactin 910 with Triclosan

    Coated vicryl plus

    Drug: coated vicryl plus

  • Active comparator
    Coated Polyglactin 910 without Triclosan

    Coated vicryl

    Drug: Vicryl

Interventions

  • Drugcoated vicryl plus

    Coated Polyglactin 910 with Triclosan (coated vicryl plus)

    Also known as: Coated Polyglactin 910 with Triclosan

  • DrugVicryl

    Coated Polyglactin 910 without Triclosan (vicryl)

    Also known as: Coated Polyglactin 910 without Triclosan

06

What researchers measure

Primary outcomes

  1. Incidence of surgical site infection

    Incidence of surgical site infection within 30 days

    Time frame: 30 days

Secondary outcomes

  1. Hospital stay

    duration of hospital stay

    Time frame: 30 days

07

Study locations

1 of 1 sites recruiting
  • Misr Univeristy for Science and Technology Hospital
    Giza, Egypt
    Recruiting
08

References and documents

Publications

  • 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. PubMed 31481559 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04256824
Lead sponsor
ClinAmygate
Collaborators
Misr University for Science and Technology, Al Safwa Hospital, Al Zohour Hospital, Al-Menia Univeristy Hospital, MSKMC Univeristy Hospital
Responsible party
Sponsor
First posted
Feb 5, 2020
Start date
Feb 5, 2020
Primary completion
Oct 10, 2023 (estimated)
Completion
Jan 30, 2024 (estimated)
Last update
Sep 6, 2023

Study contacts

Emad R Issak, Diploma
Contact
dr.emad.r.h.issak@gmail.com
00201272228989
Emad R Issak, Diploma
study director · ClinAmygate

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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