Back to resultsTriclosan-antibacterial Sutures Impact on the Incidence of Surgical Site Infection in Laparoscopic Surgeries.
Primary Purpose
Laparoscopic Surgery, Surgical Wound, Surgical Site Infection
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Coated Vicryl plus
Coated vicryl
Sponsored by
About this trial
This is an interventional prevention trial for Laparoscopic Surgery
Eligibility Criteria
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.
Sites / Locations
- Misr Univeristy for Science and Technology Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Coated Polyglactin 910 with Triclosan
Coated Polyglactin 910 without Triclosan
Arm Description
Coated Polyglactin 910 with Triclosan
Coated Polyglactin 910 without Triclosan
Outcomes
Primary Outcome Measures
port site infection (PSI)
the incidence of port site infection (PSI)
Secondary Outcome Measures
hospital stay
Post-operative hospital stay in days
Full Information
NCT ID
NCT04255927
First Posted
February 3, 2020
Last Updated
May 5, 2022
Sponsor
ClinAmygate
Collaborators
Misr University for Science and Technology, Al Safwa Hospital, Fayoum University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04255927
Brief Title
Triclosan-antibacterial Sutures Impact on the Incidence of Surgical Site Infection in Laparoscopic Surgeries.
Official Title
Triclosan-antibacterial Sutures Impact on the Incidence of Surgical Site Infection in Laparoscopic Sleeve Gastrectomy, Laparoscopic Appendectomy or Laparoscopic Cholecystectomy; Multi-center, Double-blind, Randomized Study.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 5, 2020 (Actual)
Primary Completion Date
March 10, 2022 (Actual)
Study Completion Date
April 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ClinAmygate
Collaborators
Misr University for Science and Technology, Al Safwa Hospital, Fayoum University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Surgery, Surgical Wound, Surgical Site Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
randomized-controlled
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
912 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coated Polyglactin 910 with Triclosan
Arm Type
Experimental
Arm Description
Coated Polyglactin 910 with Triclosan
Arm Title
Coated Polyglactin 910 without Triclosan
Arm Type
Active Comparator
Arm Description
Coated Polyglactin 910 without Triclosan
Intervention Type
Drug
Intervention Name(s)
Coated Vicryl plus
Other Intervention Name(s)
Coated Polyglactin 910 with Triclosan
Intervention Description
Vicryl plus (Coated Polyglactin 910 with Triclosan)
Intervention Type
Drug
Intervention Name(s)
Coated vicryl
Other Intervention Name(s)
Coated Polyglactin 910 without Triclosan
Intervention Description
Vicryl (Coated Polyglactin 910 without Triclosan)
Primary Outcome Measure Information:
Title
port site infection (PSI)
Description
the incidence of port site infection (PSI)
Time Frame
30 days
Secondary Outcome Measure Information:
Title
hospital stay
Description
Post-operative hospital stay in days
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emad R Issak, Diploma
Organizational Affiliation
ClinAmygate
Official's Role
Study Director
Facility Information:
Facility Name
Misr Univeristy for Science and Technology Hospital
City
Giza
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31481559
Citation
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.
Results Reference
result
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Triclosan-antibacterial Sutures Impact on the Incidence of Surgical Site Infection in Laparoscopic Surgeries.
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