Emergency SurgeryPhase 4NCT07048899
Irrisept in Emergency General Surgery Patients
A Phase 4 study testing Chlorhexidine and Normal Saline in people with Emergency Surgery and Surgical Site Infections, run by The University of Texas Health Science Center at Tyler at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Surgery, Surgical Site Infections
- What is being tested?
- Chlorhexidine and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2024to Apr 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Those \<18 years of age
- Pressure wounds
- Superficial abscesses (as primary diagnosis)
- intra-abdominal abscess due to previous technical failure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Irrisept Irrigation in Emergency General Surgery Cases on SSI Rates
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.
- Conditions
- Emergency Surgery, Surgical Site Infections
- Being tested
- Chlorhexidine, Normal Saline
- Keywords
- Irrisept, Surgical Irrigation, Surgical Site Infection, Emergency General Surgery, Acute Care Surgery, Normal Saline Irrigation
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChlorhexidineDrug
Also called Irrisept
Intraperitoneal irrigation with Irrisept solution
Normal SalineDrug
Also called Standard of Care
Intraperitoneal irrigation with normal saline
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (Normal Saline) | Placebo comparator | Irrigation with Normal Saline Receives: Drug: Normal Saline |
| Intervention (Irrisept) | Experimental | Irrigation with Irrisept Receives: Drug: Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection Rate
Determine if the rate of SSI is different
Measured: Time of enrollment to 30 days
Secondary outcomes (3)
Length of Stay
Number of days admitted to hospital
Measured: 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
Correlation between surgical wound class and the use of Irrisept on the incidence of SSI
Measured: Time of enrollment to 30 days
Readmission Rates due to SSI
How often a patient has to be re-admitted to the hospital for a surgical site infection
Measured: From day of surgery to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start4 Sep 2024
- Primary completionDec 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at Tyler
- Sponsor type
- University, hospital or other
- Collaborators
- Irrimax Corporation
- Responsible party
- Principal investigator, Brittany Wagner, The University of Texas Health Science Center at Tyler
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048899
- Sponsor's protocol ID
- 2024-122
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the result publication
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Irrisept Irrigation in Emergency General Surgery Cases on SSI Rates
- ClinicalTrials.gov ID
- NCT07048899
- Acronym / sponsor ID
- 2024-122
- Conditions
- Emergency Surgery, Surgical Site Infections
- Keywords
- Irrisept, Surgical Irrigation, Surgical Site Infection, Emergency General Surgery, Acute Care Surgery, Normal Saline Irrigation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at TylerUniversity, hospital or other
- Collaborators
- Irrimax Corporation
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (Normal Saline) | Placebo comparator | Drug: Normal SalineIrrigation with Normal Saline |
| Intervention (Irrisept) | Experimental | Drug: ChlorhexidineIrrigation with Irrisept |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- Those \<18 years of age
- Pressure wounds
- Superficial abscesses (as primary diagnosis)
- intra-abdominal abscess due to previous technical failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChlorhexidineAlso: IrriseptIntraperitoneal irrigation with Irrisept solution | Drug | Intervention (Irrisept) |
| Normal SalineAlso: Standard of CareIntraperitoneal irrigation with normal saline | Drug | Standard of Care (Normal Saline) |
Primary outcome
Surgical Site Infection Rate
Time frame: Time of enrollment to 30 days
Determine if the rate of SSI is different
3 secondary outcomes
Length of Stay
Time frame: 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
Time frame: Time of enrollment to 30 days
Readmission Rates due to SSI
Time frame: From day of surgery to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: Yes. Only IPD used in the result publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chlorhexidine and Normal Saline in people with Emergency Surgery and Surgical Site Infections, run by The University of Texas Health Science Center at Tyler at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection Rate (time frame: Time of enrollment to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.