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OpenTrials
Completed

NCT Number: NCT03155178

In Vivo Preoperative Skin Preparation Persistence Evaluation

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

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Key information

Conditions

Bacterial Recovery of Skin Flora Post-product Application

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3M CHG/IPA Prep

Drug

Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes.

Other names: Chlorhexidine Gluconate and Isopropyl Alcohol, CHG/IPA

Chloraprep

Drug

Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes.

Other names: Chlorhexidine Gluconate and Isopropyl Alcohol, Chlorhexidine 2% / Isopropyl alcohol 70%, CHG/IPA, ChloraPrep One-Step

Primary outcomes

  1. Measurement of Skin Flora Recovery Post-prep Application

    Time frame: Baseline, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment

    The primary measure of persistence is the suppression of regrowth recovery relative to baseline (log10 CFU/cm^2) of skin flora at 3 defined post-treatment sampling times.

Secondary outcomes

  1. Change in Skin Flora Relative to 10 Minutes Post-prep Application

    Time frame: 10-minute post-treatment, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment

    Log10 CFU/cm^2 regrowth of skin flora, relative to 10-minute post-treatment log10 CFU/cm^2, at 3 defined post-treatment sampling times.

Other outcomes

  1. Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment

    Time frame: Assessed at baseline (pre-treatment) and 10 minutes post-treatment, 48 hours post-treatment, 72 hours post-treatment, 96 hours post-treatment

    Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale: 0=no reaction, 1=mild, 2=moderate, 3=severe.

Sponsors and collaborators

Lead sponsor

Solventum US LLC

Industry

Collaborators

  • 3M

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 16, 2017
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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