Trial Outcomes & Findings for Perioperative Patient Skin Antiseptic Preparation Evaluation (NCT NCT04756804)

NCT ID: NCT04756804

Last Updated: 2024-03-20

Results Overview

The primary objective is to demonstrate efficacy in surgical use through the rate of surgical site infections.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

51 participants

Primary outcome timeframe

Within 30 days after surgery

Results posted on

2024-03-20

Participant Flow

Participant milestones

Participant milestones
Measure	70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic 70% v/v Isopropyl Alcohol novel preoperative skin antisepsis preparation 70% v/v Isopropyl Alcohol Surgical Solution: Patient preoperative skin preparation	2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antisepsis preparation 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol: Patient preoperative skin preparation
Overall Study STARTED	25	26
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Perioperative Patient Skin Antiseptic Preparation Evaluation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic n=25 Participants 70% v/v Isopropyl Alcohol novel preoperative skin antisepsis preparation 70% v/v Isopropyl Alcohol Surgical Solution: Patient preoperative skin preparation	2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic n=26 Participants 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antisepsis preparation 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol: Patient preoperative skin preparation	Total n=51 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	15 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 30 days after surgery

The primary objective is to demonstrate efficacy in surgical use through the rate of surgical site infections.

Outcome measures

Outcome measures
Measure	70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic n=25 Participants 70% v/v Isopropyl Alcohol novel preoperative skin antisepsis preparation 70% v/v Isopropyl Alcohol Surgical Solution: Patient preoperative skin preparation	2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic n=26 Participants 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antisepsis preparation 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol: Patient preoperative skin preparation
Surgical Site Infection Occurrence	0 Participants	1 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic n=25 Participants 70% v/v Isopropyl Alcohol novel preoperative skin antisepsis preparation 70% v/v Isopropyl Alcohol Surgical Solution: Patient preoperative skin preparation	2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic n=26 Participants 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antisepsis preparation 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol: Patient preoperative skin preparation
Allergic Reaction and Skin Irritation	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic n=25 Participants 70% v/v Isopropyl Alcohol novel preoperative skin antisepsis preparation 70% v/v Isopropyl Alcohol Surgical Solution: Patient preoperative skin preparation	2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic n=26 Participants 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antisepsis preparation 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol: Patient preoperative skin preparation
Subgroup Analysis of Rates of Surgical Site Infections superficial incisional infection	0 Participants	0 Participants
Subgroup Analysis of Rates of Surgical Site Infections deep incisional infection	0 Participants	1 Participants
Subgroup Analysis of Rates of Surgical Site Infections organ-space infection	0 Participants	0 Participants
Subgroup Analysis of Rates of Surgical Site Infections No surgical site infection present	25 Participants	25 Participants

SECONDARY outcome

Timeframe: Within 30 days after surgery

Population: 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.

Surgical site infection rates by type of surgery including clean (class I wound) or clean-contaminated (class II wounds) surgeries

Outcome measures

Outcome measures
Measure	70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic 70% v/v Isopropyl Alcohol novel preoperative skin antisepsis preparation 70% v/v Isopropyl Alcohol Surgical Solution: Patient preoperative skin preparation	2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic n=1 Participants 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antisepsis preparation 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol: Patient preoperative skin preparation
Subgroup Analysis of Rates of Surgical Site Infections Class I - Clean	0 Participants	1 Participants
Subgroup Analysis of Rates of Surgical Site Infections Class II - Clean-Contaminated	0 Participants	0 Participants

Adverse Events

70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic

Serious events: 11 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

VP, Reg Affairs

Zurex Pharma, Inc.

Phone: 608.203.9090

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic n=25 participants at risk 70% v/v Isopropyl Alcohol novel preoperative skin antisepsis preparation 70% v/v Isopropyl Alcohol Surgical Solution: Patient preoperative skin preparation	2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic n=26 participants at risk 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antisepsis preparation 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol: Patient preoperative skin preparation
Cardiac disorders Cardiac Distress	4.0% 1/25 • Number of events 1 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).	0.00% 0/26 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).
Respiratory, thoracic and mediastinal disorders Pulmonary Distress	4.0% 1/25 • Number of events 1 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).	0.00% 0/26 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).
Renal and urinary disorders Renal Distress	4.0% 1/25 • Number of events 1 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).	0.00% 0/26 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).
Blood and lymphatic system disorders Acute Blood Loss Anemia	4.0% 1/25 • Number of events 1 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).	0.00% 0/26 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).
Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress	0.00% 0/25 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).	3.8% 1/26 • Number of events 1 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).
Cardiac disorders Heart Failure Exacerbation	4.0% 1/25 • Number of events 1 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).	3.8% 1/26 • Number of events 1 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).
Metabolism and nutrition disorders Lactic Acidosis	0.00% 0/25 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).	3.8% 1/26 • Number of events 1 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/25 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).	3.8% 1/26 • Number of events 1 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).
Hepatobiliary disorders Hepatic Failure	0.00% 0/25 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).	3.8% 1/26 • Number of events 1 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).
Vascular disorders Acute Circulatory Failure	0.00% 0/25 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).	3.8% 1/26 • Number of events 1 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).
Cardiac disorders Cardiogenic Shock	0.00% 0/25 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).	3.8% 1/26 • Number of events 1 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).
Renal and urinary disorders Occlusion of Renal Artery	0.00% 0/25 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).	3.8% 1/26 • Number of events 1 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).
Injury, poisoning and procedural complications Cerebral Hyperperfusion	4.0% 1/25 • Number of events 1 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).	0.00% 0/26 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).
General disorders Chest Pain	4.0% 1/25 • Number of events 1 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).	0.00% 0/26 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).
Vascular disorders Hypervolemic Shock	0.00% 0/25 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).	3.8% 1/26 • Number of events 1 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).
Psychiatric disorders Altered Mental State	4.0% 1/25 • Number of events 1 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).	0.00% 0/26 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).
Vascular disorders Hypertension	4.0% 1/25 • Number of events 1 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).	0.00% 0/26 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).
General disorders Endoleak	4.0% 1/25 • Number of events 1 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).	0.00% 0/26 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).
Nervous system disorders TIA	0.00% 0/25 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).	3.8% 1/26 • Number of events 1 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).
Injury, poisoning and procedural complications Surgical Site Infection	0.00% 0/25 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).	3.8% 1/26 • Number of events 1 • AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).