In Vivo Preoperative Skin Preparation Persistence Evaluation

Solventum US LLC

Status and phase: Completed; Phase 2

Conditions: Bacterial Recovery of Skin Flora Post-product Application

Treatments: Drug: ChloraPrep; Drug: 3M CHG/IPA Prep

Study type: Interventional

Funder types: Industry

Identifiers

NCT03155178

EM-013953

Details and patient eligibility

About

Evaluate persistent antimicrobial effectiveness of chlorhexidine gluconate containing products on abdominal and inguinal sites following a saline and wipe challenge.

Full description

Persistent antimicrobial effectiveness was evaluated by measuring the regrowth of normal skin flora at 48 hours, 72 hours and 96 hours, and the suppression of regrowth relative to post-prep (10-min) at 48 hours, 72 hours and 96 hours.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects of any race
• Subjects in good health
• Minimum skin flora baseline requirements on abdomen and groin

Exclusion criteria

• Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test area
• Topical antimicrobial exposure within 14 days prior to screening and treatment days
• Use of systemic or topical antibiotics, steroid medications, or any other products known to affect the normal microbial flora of the skin within 14 days prior to screening and treatment days

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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69 participants in 2 patient groups

3M CHG/IPA Prep

Experimental group

Description:

Apply topically for 30 seconds (abdominal site) or 2 minutes (inguinal site), and allow to dry for 3 minutes.

Treatment:

Drug: 3M CHG/IPA Prep

ChloraPrep

Active Comparator group

Description:

Apply topically for 30 seconds (abdominal site) or 2 minutes (inguinal site), and allow to dry for 3 minutes.

Treatment:

Drug: ChloraPrep