Perioperative Patient Skin Antiseptic Preparation Evaluation

Zurex Pharma

Status and phase: Completed; Phase 3

Conditions: Surgical Site Infection

Treatments: Drug: 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol; Drug: 70% v/v Isopropyl Alcohol Surgical Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT04756804

ZXZP0113

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

70% Isopropyl Alcohol novel preoperative skin antiseptic

Experimental group

Description:

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

Treatment:

Drug: 70% v/v Isopropyl Alcohol Surgical Solution

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

Active Comparator group

Description:

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

Treatment:

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