Trial · NCT04756804
Perioperative Patient Skin Antiseptic Preparation Evaluation
NCT04756804, Phase 3, Completed, Zurex Pharma, Inc.; results first posted 2024-03-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Perioperative Patient Skin Antiseptic Preparation Evaluation. Trials, record NCT04756804. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04756804
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Perioperative Patient Skin Antiseptic Preparation Evaluation
- NCT number
- NCT04756804
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 51 participants, actual
- Lead sponsor
- Zurex Pharma, Inc.
- Conditions
- Surgical Site Infection
- Interventions
- 70% v/v Isopropyl Alcohol Surgical Solution, 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol
- First posted
- 2021-02-16
- Last updated
- 2024-03-20
- Results first posted
- 2024-03-20
- Limitations and caveats
- This was a pilot study of surgical patients, the majority of which had significant comorbidities with several AEs reported in more than one patient across the study.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Surgical Site Infection Occurrence | Within 30 days after surgery | The primary objective is to demonstrate efficacy in surgical use through the rate of surgical site infections. |
| Primary | Allergic Reaction and Skin Irritation | 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. |
| Secondary | Subgroup Analysis of Rates of Surgical Site Infections | Within 30 days after surgery | Surgical site infection rates by different infection types classified as superficial incisional infection, deep incisional infection, or organ-space infection. |
| Secondary | Subgroup Analysis of Rates of Surgical Site Infections | Within 30 days after surgery | Surgical site infection rates by type of surgery including clean (class I wound) or clean-contaminated (class II wounds) surgeries |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Surgical Site Infection Occurrence | Within 30 days after surgery | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Allergic Reaction and Skin Irritation | Within 30 days after surgery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Subgroup Analysis of Rates of Surgical Site Infections | Within 30 days after surgery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Subgroup Analysis of Rates of Surgical Site Infections | Within 30 days after surgery | Secondary outcome categorizes the results of the primary outcome - surgical site infections. The study only resulted in observation of 1 surgical site infection in one of the two interventions. Therefore, the novel prep secondary outcome results in a zero value reported. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Surgical Site Infection Occurrence | 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic | 0 | Participants | ||
| Surgical Site Infection Occurrence | 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic | 1 | Participants | ||
| Allergic Reaction and Skin Irritation | 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic | 1 | Participants | ||
| Allergic Reaction and Skin Irritation | 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic | 1 | Participants | ||
| Subgroup Analysis of Rates of Surgical Site Infections | 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic | superficial incisional infection | 0 | Participants | |
| Subgroup Analysis of Rates of Surgical Site Infections | 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic | superficial incisional infection | 0 | Participants | |
| Subgroup Analysis of Rates of Surgical Site Infections | 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic | deep incisional infection | 0 | Participants | |
| Subgroup Analysis of Rates of Surgical Site Infections | 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic | deep incisional infection | 1 | Participants | |
| Subgroup Analysis of Rates of Surgical Site Infections | 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic | organ-space infection | 0 | Participants | |
| Subgroup Analysis of Rates of Surgical Site Infections | 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic | organ-space infection | 0 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic | 25 | |
| Overall Study | STARTED | 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic | 26 | |
| Overall Study | COMPLETED | 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic | 25 | |
| Overall Study | COMPLETED | 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic | 25 | |
| Overall Study | NOT COMPLETED | 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic | 0 | |
| Overall Study | NOT COMPLETED | 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic | 1 |
Source ClinicalTrials.gov
Adverse events40
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Cardiac Distress | Cardiac disorders | 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic | 1 | 25 | 1 |
| serious | Cardiac Distress | Cardiac disorders | 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic | 0 | 26 | 0 |
| serious | Pulmonary Distress | Respiratory, thoracic and mediastinal disorders | 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic | 1 | 25 | 1 |
| serious | Pulmonary Distress | Respiratory, thoracic and mediastinal disorders | 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic | 0 | 26 | 0 |
| serious | Renal Distress | Renal and urinary disorders | 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic | 1 | 25 | 1 |
| serious | Renal Distress | Renal and urinary disorders | 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic | 0 | 26 | 0 |
| serious | Acute Blood Loss Anemia | Blood and lymphatic system disorders | 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic | 1 | 25 | 1 |
| serious | Acute Blood Loss Anemia | Blood and lymphatic system disorders | 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic | 0 | 26 | 0 |
| serious | Acute Respiratory Distress | Respiratory, thoracic and mediastinal disorders | 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic | 0 | 25 | 0 |
| serious | Acute Respiratory Distress | Respiratory, thoracic and mediastinal disorders | 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic | 1 | 26 | 1 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic | 0 | 25 |
| Total, all-cause mortality | 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic | 1 | 26 |
| Total, other adverse events | 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic | 0 | 25 |
| Total, other adverse events | 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic | 0 | 26 |
| Total, serious adverse events | 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic | 10 | 25 |
| Total, serious adverse events | 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic | 11 | 26 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic vs 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic: Surgical Site Infection Occurrence | Trial comparisons |
| 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic vs 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic: deaths from any cause | Trial comparisons |
| 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic vs 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic: Allergic Reaction and Skin Irritation | Trial comparisons |
| 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic vs 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04756804
GET https://conductscience.org/api/trials/v1/NCT04756804/events?page=2