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Completed

NCT Number: NCT02447497

In Vivo Patient Preoperative Skin Prep Persistence

The objective of the study is to demonstrate persistence of the CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.

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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

Primary location

MicroBioTest

Sterling, Virginia, 20164, United States

About this study

The objective of the study is to demonstrate persistence of the CHG/IPA Prep versus a saline placebo on skin flora of the abdominal and inguinal regions of human subjects as measured by change in microbial flora relative to baseline.

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

3M CHG/IPA Surgical Skin Preparation - Abdominal Region

Drug

Chlorhexidine gluconate 2% / Isopropyl alcohol 70%

Other names: SoluPrep

Normal Saline - Abdominal Region

Other

0.9% sodium chloride applied with foam applicator

3M CHG/IPA Surgical Skin Preparation - Inguinal Region

Drug

Chlorhexidine gluconate 2% / Isopropyl alcohol 70%

Other names: SoluPrep

Normal Saline - Inguinal Region

Other

0.9% sodium chloride applied with foam applicator

Primary outcomes

  1. Measurement of Skin Flora Recovery Post-prep Application Relative to Baseline

    Time frame: Baseline, 48 hours and 72 hours post-prep application

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

Secondary outcomes

  1. Safety as Assessed by Skin Irritation Scores Coded by Study Staff

    Time frame: 48 hours and 72 hours post-product application

    For the conditions of erythema, edema, rash, and dryness, a rating of 0 (no reaction), 1 (mild and/or transient, limited to sensitive area), 2 (moderate, persisting over much of the product-exposed area), or 3 (severe, extending over most or all of the product-exposed area) was recorded on the Skin Irritation Rating form of the eCRF.

  2. Safety as Assessed by Adverse Events

    Time frame: To 72 hours post treatment

    Number of subjects with adverse events as self-reported or identified by study staff

Sponsors and collaborators

Lead sponsor

Solventum US LLC

Industry

Collaborators

  • 3M

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 19, 2015
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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