Surgical Site InfectionPhase 3NCT04756804
Perioperative Patient Skin Antiseptic Preparation Evaluation
A Phase 3 study testing 70% v/v Isopropyl Alcohol Surgical Solution and 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol in people with Surgical Site Infection, run by Zurex Pharma, Inc. at 1 site in United States.
Trial summary
This study will evaluate a new topical skin antiseptic perioperative preparation and the standard of care to determine efficacy on the rates of surgical site infections of surgical patients. Safety will also be assessed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- 70% v/v Isopropyl Alcohol Surgical Solution and 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2021to 29 Sep 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be male or female and at least 18 years of age.
- Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English.
- Be planning to undergo clean (class I wound) or clean-contaminated (class II wounds) surgery.
- Expect to be available for up to 30-days after the surgery.
Who cannot join
- Active infection or fever including evidence of infection at or adjacent to the operative site.
- Immunosuppressed.
- Kidney/liver failure.
- Immunosuppressive therapy (chemotherapy, steroids) within the previous 1 week.
- Any history of allergy to chlorhexidine or isopropyl alcohol or any other component in ZuraGard including citric acid, sodium citrate, methylparaben, or propylparaben, and FD\&C Yellow #6.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled Clinical Trial Evaluating A Novel Perioperative Patient Skin Antiseptic Preparation
This study will evaluate a new topical skin antiseptic perioperative preparation and the standard of care to determine efficacy on the rates of surgical site infections of surgical patients. Safety will also be assessed.
- Conditions
- Surgical Site Infection
- Being tested
- 70% v/v Isopropyl Alcohol Surgical Solution, 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol
- 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.
70% v/v Isopropyl Alcohol Surgical SolutionDrug
Also called ZuraGard
Patient preoperative skin preparation
2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl AlcoholDrug
Also called ChloraPrep
Patient preoperative skin preparation
| Study group | Role | What they receive |
|---|---|---|
| 70% Isopropyl Alcohol novel preoperative skin antiseptic | Experimental | 70% v/v Isopropyl Alcohol novel preoperative skin antisepsis preparation Receives: Drug: 70% v/v Isopropyl Alcohol Surgical Solution |
| 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antiseptic | Active comparator | 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antisepsis preparation Receives: Drug: 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection Occurrence
The primary objective is to demonstrate efficacy in surgical use through the rate of surgical site infections.
Measured: Within 30 days after surgery
Allergic Reaction and Skin Irritation
The primary safety objective is to determine the rates of skin irritation or allergic reactions attributed to each drug product and all other adverse events.
Measured: Within 30 days after surgery
Secondary outcomes (2)
Subgroup Analysis of Rates of Surgical Site Infections
Surgical site infection rates by different infection types classified as superficial incisional infection, deep incisional infection, or organ-space infection.
Measured: Within 30 days after surgery
Subgroup Analysis of Rates of Surgical Site Infections
Surgical site infection rates by type of surgery including clean (class I wound) or clean-contaminated (class II wounds) surgeries
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start21 Jun 2021
- Primary completion29 Sep 2022
- Study completion29 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Surgical Site InfectionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zurex Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph P Hart, MD, FACS, DFSVS, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756804
- Sponsor's protocol ID
- ZXZP0113
- Status last verified
- Feb 2024
- First submitted
- 11 Feb 2021
- Last updated
- 20 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Clinical Trial Evaluating A Novel Perioperative Patient Skin Antiseptic Preparation
- ClinicalTrials.gov ID
- NCT04756804
- Acronym / sponsor ID
- ZXZP0113
- Conditions
- Surgical Site Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Zurex Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 29 Sep 2022 (actual)
- Study completion
- 29 Sep 2022 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Posted 20 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate a new topical skin antiseptic perioperative preparation and the standard of care to determine efficacy on the rates of surgical site infections of surgical patients. Safety will also be assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 70% Isopropyl Alcohol novel preoperative skin antiseptic | Experimental | Drug: 70% v/v Isopropyl Alcohol Surgical Solution70% v/v Isopropyl Alcohol novel preoperative skin antisepsis preparation |
| 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antiseptic | Active comparator | Drug: 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antisepsis preparation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be male or female and at least 18 years of age.
- Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English.
- Be planning to undergo clean (class I wound) or clean-contaminated (class II wounds) surgery.
- Expect to be available for up to 30-days after the surgery.
Key exclusion criteria (5 listed)
- Active infection or fever including evidence of infection at or adjacent to the operative site.
- Immunosuppressed.
- Kidney/liver failure.
- Immunosuppressive therapy (chemotherapy, steroids) within the previous 1 week.
- Any history of allergy to chlorhexidine or isopropyl alcohol or any other component in ZuraGard including citric acid, sodium citrate, methylparaben, or propylparaben, and FD\&C Yellow #6.
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 |
|---|---|---|
| 70% v/v Isopropyl Alcohol Surgical SolutionAlso: ZuraGardPatient preoperative skin preparation | Drug | 70% Isopropyl Alcohol novel preoperative skin antiseptic |
| 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl AlcoholAlso: ChloraPrepPatient preoperative skin preparation | Drug | 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antiseptic |
Primary outcome
Surgical Site Infection Occurrence
Time frame: Within 30 days after surgery
The primary objective is to demonstrate efficacy in surgical use through the rate of surgical site infections.
Allergic Reaction and Skin Irritation
Time frame: Within 30 days after surgery
The primary safety objective is to determine the rates of skin irritation or allergic reactions attributed to each drug product and all other adverse events.
2 secondary outcomes
Subgroup Analysis of Rates of Surgical Site Infections
Time frame: Within 30 days after surgery
Subgroup Analysis of Rates of Surgical Site Infections
Time frame: Within 30 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Surgical Site Infection
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
RecruitingObservational study
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Surgical Site Infection
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
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. This study is not recruiting at the moment.
Joseph P Hart, MD, FACS, DFSVS principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 70% v/v Isopropyl Alcohol Surgical Solution and 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol in people with Surgical Site Infection, run by Zurex Pharma, Inc. 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 20 Mar 2024. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Occurrence (time frame: Within 30 days after surgery). The study lists 2 primary outcomes in all. 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 20 Mar 2024.