In Vivo Patient Preoperative Skin Prep Persistence

Solventum US LLC

Status and phase: Completed; Phase 2

Conditions: Bacterial Recovery of Skin Flora Post-Product Application

Treatments: Drug: 3M CHG/IPA Surgical Skin Preparation - Abdominal Region; Drug: 3M CHG/IPA Surgical Skin Preparation - Inguinal Region; Other: Normal Saline - Abdominal Region; Other: Normal Saline - Inguinal Region

Study type: Interventional

Funder types: Industry

Identifiers

NCT02447497

EM-05-013509

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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27 participants in 4 patient groups, including a placebo group

3M CHG/IPA - Abdominal Region

Experimental group

Description:

Apply Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70% for 30 seconds and allow to dry for 3 minutes.

Treatment:

Drug: 3M CHG/IPA Surgical Skin Preparation - Abdominal Region

Normal Saline - Abdominal Region

Placebo Comparator group

Description:

Apply 0.9% sodium chloride with applicator for 30 seconds and allow to dry for 3 minutes.

Treatment:

Other: Normal Saline - Abdominal Region

3M CHG/IPA - Inguinal Region

Experimental group

Description:

Apply Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70% for 30 seconds and allow to dry for 3 minutes.

Treatment:

Drug: 3M CHG/IPA Surgical Skin Preparation - Inguinal Region

Normal Saline - Inguinal Region

Placebo Comparator group

Description:

Apply 0.9% sodium chloride with applicator for 30 seconds and allow to dry for 3 minutes.

Treatment:

Other: Normal Saline - Inguinal Region