Triclosan-antibacterial Sutures Impact on the Incidence of Surgical Site Infection in Laparoscopic Surgeries.
1 other identifier
interventional
912
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2020
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedStudy Start
First participant enrolled
February 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2022
CompletedMay 11, 2022
May 1, 2022
2.1 years
February 3, 2020
May 5, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
port site infection (PSI)
the incidence of port site infection (PSI)
30 days
Secondary Outcomes (1)
hospital stay
30 days
Study Arms (2)
Coated Polyglactin 910 with Triclosan
EXPERIMENTALCoated Polyglactin 910 with Triclosan
Coated Polyglactin 910 without Triclosan
ACTIVE COMPARATORCoated Polyglactin 910 without Triclosan
Interventions
Vicryl plus (Coated Polyglactin 910 with Triclosan)
Vicryl (Coated Polyglactin 910 without Triclosan)
Eligibility Criteria
You may qualify if:
- age 18-75
- candidate for laparoscopic surgical intervention during the period of the study were included.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ClinAmygatelead
- Misr University for Science and Technologycollaborator
- Al Safwa Hospitalcollaborator
- Fayoum University Hospitalcollaborator
Study Sites (1)
Misr Univeristy for Science and Technology Hospital
Giza, Egypt
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: 31481559RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Emad R Issak, Diploma
ClinAmygate
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
February 3, 2020
First Posted
February 5, 2020
Study Start
February 5, 2020
Primary Completion
March 10, 2022
Study Completion
April 20, 2022
Last Updated
May 11, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share