Back to resultsTriclosan-antibacterial Sutures Efficacy on the Incidence of Surgical Site Infection in Clean-contaminated Wounds
Primary Purpose
Surgical Site Infection, Surgical Wound, Surgical Wound Infection
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
coated vicryl plus
Vicryl
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Site Infection
Eligibility Criteria
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.
Sites / Locations
- Misr Univeristy for Science and Technology HospitalRecruiting
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 vicryl plus
Coated vicryl
Outcomes
Primary Outcome Measures
Incidence of surgical site infection
Incidence of surgical site infection within 30 days
Secondary Outcome Measures
Hospital stay
duration of hospital stay
Full Information
NCT ID
NCT04256824
First Posted
February 3, 2020
Last Updated
September 4, 2023
Sponsor
ClinAmygate
Collaborators
Misr University for Science and Technology, Al Safwa Hospital, Al Zohour Hospital, Al-Menia Univeristy Hospital, MSKMC Univeristy Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04256824
Brief Title
Triclosan-antibacterial Sutures Efficacy on the Incidence of Surgical Site Infection in Clean-contaminated Wounds
Official Title
Triclosan-antibacterial Sutures Efficacy on the Incidence of Surgical Site Infection in Clean-contaminated Wounds; Multi-center, Double Blind, Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 5, 2020 (Actual)
Primary Completion Date
October 10, 2023 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ClinAmygate
Collaborators
Misr University for Science and Technology, Al Safwa Hospital, Al Zohour Hospital, Al-Menia Univeristy Hospital, MSKMC Univeristy 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 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection, Surgical Wound, Surgical Wound Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
randomized-controlled study
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
430 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Coated Polyglactin 910 with Triclosan
Arm Type
Experimental
Arm Description
Coated vicryl plus
Arm Title
Coated Polyglactin 910 without Triclosan
Arm Type
Active Comparator
Arm Description
Coated vicryl
Intervention Type
Drug
Intervention Name(s)
coated vicryl plus
Other Intervention Name(s)
Coated Polyglactin 910 with Triclosan
Intervention Description
Coated Polyglactin 910 with Triclosan (coated vicryl plus)
Intervention Type
Drug
Intervention Name(s)
Vicryl
Other Intervention Name(s)
Coated Polyglactin 910 without Triclosan
Intervention Description
Coated Polyglactin 910 without Triclosan (vicryl)
Primary Outcome Measure Information:
Title
Incidence of surgical site infection
Description
Incidence of surgical site infection within 30 days
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Hospital stay
Description
duration of hospital stay
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
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emad R Issak, Diploma
Phone
00201272228989
Email
dr.emad.r.h.issak@gmail.com
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moatasem-Bellah A Erfaan, MD
Phone
01223478555
Email
mustmedicine@gmail.com
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
Learn more about this trial
Triclosan-antibacterial Sutures Efficacy on the Incidence of Surgical Site Infection in Clean-contaminated Wounds
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