Irrisept in Emergency General Surgery Patients | NCT07048899

Studies
Irrisept in Emergency General Surgery Patients

NCT07048899

Sponsor

The University of Texas Health Science Center at Tyler

Status

Enrolling by invitation

Last Update Posted

Jul 3, 2025Actual

Enrollment

400Estimated

Phase

Phase 4

Conditions

Emergency Surgery
Surgical Site Infections

Interventions

Chlorhexidine
Normal Saline

Countries

United States

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

Jun 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 4, 2024Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Apr 2026Estimated

First Submitted Date

Jun 11, 2025

First Submission Date that Met QC Criteria

Jun 29, 2025

First Posted Date

Jul 3, 2025Actual

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

Jun 29, 2025

Last Update Posted Date

Jul 3, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Brittany Wagner, General Surgery Resident, The University of Texas Health Science Center at TylerPrincipal Investigator

Lead Sponsor

The University of Texas Health Science Center at TylerOTHER

Collaborators

Name	Class
Irrimax Corporation	INDUSTRY

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a single institution, randomized study conducted to determine if irrigation with Irrisept in emergency general surgery patients results in lower surgical site infections compared to normal saline irrigation.

Detailed Description

Not provided

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

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard of Care (Normal Saline)	Placebo Comparator	Irrigation with Normal Saline	Drug: Normal Saline
Intervention (Irrisept)	Experimental	Irrigation with Irrisept	Drug: Chlorhexidine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chlorhexidine	Drug	Intraperitoneal irrigation with Irrisept solution	Intervention (Irrisept)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Surgical Site Infection Rate	Determine if the rate of SSI is different	Time of enrollment to 30 days

Secondary Outcomes

Measure	Description	Time Frame
Length of Stay	Number of days admitted to hospital	From date of admission until date of discharge from the hospital, assessed up to 30 days post-operatively
Incidence of SSI and surgical wound class with the use of Irrisept

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients (>18 years old at time of enrollment) who are hospitalized at UT Tyler and undergo an open (or conversion to open) wound class 2-4 surgical procedure for an emergent surgical condition.

Exclusion Criteria:

Those <18 years of age
Pressure wounds
Superficial abscesses (as primary diagnosis)
intra-abdominal abscess due to previous technical failure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UT Health Tyler		Tyler	Texas	75701	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Only IPD used in the result publication

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

Beginning after completion of project and ending 5 years after publication of results

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013530	Surgical Wound Infection

Ancestor Terms

ID	Term
D014946	Wound Infection
D007239	Infections
D011183	Postoperative Complications
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002710	Chlorhexidine
D000077330	Saline Solution
D059039	Standard of Care

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals
D000077324

Browse Leaves

Not provided

Browse Branches

Not provided