NCT03155178

In Vivo Preoperative Skin Preparation Persistence Evaluation

96-hour Antimicrobial Persistence Assessment Following Exposure to Saline and Blotting

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Solventum US LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Bacterial Recovery of Skin Flora Post-product Application

Interventions

Type	Name	Description
DRUG	3M CHG/IPA Prep	Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes.
DRUG	ChloraPrep	Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes.

Timeline

• Start date: 2016-12-05
• Primary completion: 2017-04-25
• Completion: 2017-04-25
• First posted: 2017-05-16
• Last updated: 2024-10-02
• Results posted: 2020-02-28

Regulatory

• FDA-regulated drug study