Triclosan-antibacterial Sutures Impact on the Incidence o... | NCT04255927

Studies
Triclosan-antibacterial Sutures Impact on the Incidence of Surgical Site Infection in Laparoscopic Surgeries.

NCT04255927

Sponsor

ClinAmygate

Status

Completed

Last Update Posted

May 11, 2022Actual

Enrollment

912Actual

Phase

Phase 4

Conditions

Laparoscopic Surgery
Surgical Wound
Surgical Site Infection

Interventions

Coated Vicryl plus
Coated vicryl

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 5, 2020Actual

Primary Completion Date

Mar 10, 2022Actual

Completion Date

Apr 20, 2022Actual

First Submitted Date

Feb 3, 2020

First Submission Date that Met QC Criteria

Feb 4, 2020

First Posted Date

Feb 5, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2022

Last Update Posted Date

May 11, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Emad R Issak, Doctor, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

ClinAmygateOTHER

Collaborators

Name	Class
Misr University for Science and Technology	OTHER
Al Safwa Hospital	UNKNOWN
Fayoum University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

912Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Coated Polyglactin 910 with Triclosan	Experimental	Coated Polyglactin 910 with Triclosan	Drug: Coated Vicryl plus
Coated Polyglactin 910 without Triclosan	Active Comparator	Coated Polyglactin 910 without Triclosan	Drug: Coated vicryl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Coated Vicryl plus	Drug	Vicryl plus (Coated Polyglactin 910 with Triclosan)	Coated Polyglactin 910 with Triclosan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
port site infection (PSI)	the incidence of port site infection (PSI)	30 days

Secondary Outcomes

Measure	Description	Time Frame
hospital stay	Post-operative hospital stay in days	30 days

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emad R Issak, Diploma	ClinAmygate	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Misr Univeristy for Science and Technology Hospital		Giza			Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31481559	Result	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.

ID	Term
D000072836	Surgical Wound
D013530	Surgical Wound Infection

ID	Term
D014947	Wounds and Injuries
D014946	Wound Infection
D007239	Infections
D011183	Postoperative Complications

ID	Term
D010647	Phenyl Ethers
D004987	Ethers
D009930	Organic Chemicals
D010636	Phenols
D001555