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Completed

NCT Number: NCT01968707

In-vivo Efficacy Study of Patient Pre-operative Preps

The purpose of this study is to determine the antimicrobial efficacy of the 3M CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.

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Key information

Conditions

Bacterial Reduction on Skin Flora Post-product Application

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Microbiotest

Sterling, Virginia, 20164, United States

About this study

The primary efficacy is evaluated by demonstration that the product provides a lower bound of the 95% confidence interval of percent responders that is greater than or equal to 70%.

On the abdominal sites, a responder is defined as a subject with a 2-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.

On the inguinal sites, a responder is defined as a subject with a 3-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 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 general 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 areas
  • 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

ChloraPrep Hi-Lite Orange

Drug

Apply topically.

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

normal saline

Drug

Apply topically.

Other names: 0.9% Sodium Chloride, Sterile Saline, 0.9% NaCl, Saline

3M CHG/IPA Prep Tint 10.5-mL

Drug

Apply topically.

Other names: Chlorhexidine Gluconate and Isopropyl Alcohol, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%, Chlorhexidine gluconate 2% w/v / Isopropyl alcohol 70% v/v, 2% CHG / 70% IPA

3M CHG/IPA Prep Tint 26-mL

Drug

Apply topically

Other names: Chlorhexidine Gluconate and Isopropyl Alcohol, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%, Chlorhexidine gluconate 2% w/v / Isopropyl alcohol 70% v/v, 2% CHG / 70% IPA

Primary outcomes

  1. Responder Rate

    Time frame: baseline, 10 minutes post-product application and 6 hour post-product application

    On the abdominal region a responder was a subject with a 2 log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline.

    On the inguinal region a responder was a subject with a 3 log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline.

Secondary outcomes

  1. Reduction of Skin Flora 6 Hours Post-treatment

    Time frame: 6 hours

    log10/cm2 reduction of skin flora, relative to treatment day baseline (log10/cm2), at 6 hours post-treatment

  2. Reduction of Skin Flora 10 Minutes Post-treatment

    Time frame: 10 minutes

    log10/cm2 reduction of skin flora, relative to treatment day baseline (log10/cm2), at 10 minutes post-treatment

  3. Skin Flora Recovery 6-hours Post-treatment

    Time frame: 6 hours post-treatment

    Log10/cm2 recovery of skin flora at 6 hours following application of study treatment

  4. Skin Flora Recovery 10 Minutes Post-treatment

    Time frame: 10 minutes post-treatment

    Log10/cm2 recovery of skin flora at 10 minutes following application of study treatments

  5. Skin Flora Baseline for the Abdominal and Inguinal Region.

    Time frame: Baseline

    Log10/cm2 baseline skin flora for abdominal and inguinal regions

  6. Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score

    Time frame: Assessed at baseline (pre-treatment) and 10 minute post-treatment and 6 hour 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=moderated, 3=severe

Sponsors and collaborators

Lead sponsor

Solventum US LLC

Industry

Collaborators

  • 3M

Registry information

Official study title

Assessment of the Antimicrobial Efficacy of 3M CHG/IPA Preoperative Skin Preparation Against Resident Human Skin Flora on the Abdominal and Inguinal Regions

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 24, 2013
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.