Perioperative Patient Skin Antiseptic Preparation Evaluation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-21

Study Completion Date

2022-09-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Surgical Site Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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70% Isopropyl Alcohol novel preoperative skin antiseptic

70% v/v Isopropyl Alcohol novel preoperative skin antisepsis preparation

Group Type EXPERIMENTAL

70% v/v Isopropyl Alcohol Surgical Solution

Intervention Type DRUG

Patient preoperative skin preparation

2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antiseptic

2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antisepsis preparation

Group Type ACTIVE_COMPARATOR

2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol

Intervention Type DRUG

Patient preoperative skin preparation

Interventions

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70% v/v Isopropyl Alcohol Surgical Solution

Patient preoperative skin preparation

Intervention Type DRUG

2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol

Patient preoperative skin preparation

Intervention Type DRUG

Other Intervention Names

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ZuraGard ChloraPrep

Eligibility Criteria

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Inclusion Criteria

1. Be male or female and at least 18 years of age.
2. 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.
3. Be planning to undergo clean (class I wound) or clean-contaminated (class II wounds) surgery.
4. Expect to be available for up to 30-days after the surgery.

Exclusion Criteria

1. Active infection or fever including evidence of infection at or adjacent to the operative site.
2. Immunosuppressed.
3. Kidney/liver failure.
4. Immunosuppressive therapy (chemotherapy, steroids) within the previous 1 week.
5. 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes