CompletedNCT02203591Updated Nov 23, 2020Results posted

In Vivo Efficacy Study of Patient Preoperative Preps

A Phase 3 interventional study of 3M CHG/IPA Prep C and 3M CHG/IPA Prep CH in Bacterial Reduction Post-product Application, sponsored by 3M. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-23.

Sponsored by 3M · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 738
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

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

Read the detailed description

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

On the inguinal site, a responder is defined as a subject with a 3-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.

Conditions studied

Bacterial Reduction Post-product Application

Keywords

surgical skin prep
CHG
IPA

In context

Lead sponsor

3M is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Subjects of any race
Subjects in good health
Minimum skin flora baseline requirements on abdomen and groin

Exclusion criteria

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

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 738 participants (actual)

Study arms

Experimental
3M CHG/IPA Prep C
Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Drug: 3M CHG/IPA Prep C
Experimental
3M CHG/IPA Prep CH
Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Drug: 3M CHG/IPA Prep CH
Active comparator
ChloraPrep
Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Drug: ChloraPrep
Placebo comparator
Normal Saline
Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Drug: Normal Saline

Interventions

Drug3M CHG/IPA Prep C
Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Also known as: Chlorhexidine Gluconate and Isopropyl Alcohol, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%, CHG 2%/IPA 70%
Drug3M CHG/IPA Prep CH
Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Also known as: Chlorhexidine Gluconate and Isopropyl Alcohol, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%, CHG 2%/IPA 70%
DrugChloraPrep
Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Also known as: ChloraPrep Patient Preoperative Skin Preparation, ChloraPrep One-Step, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%, CHG2%/IPA 70%, Chlorhexidine Gluconate and Isopropyl Alcohol
DrugNormal Saline
Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Also known as: Sodium Chloride 0.9%, Saline

What researchers measure

Primary outcomes

Responder Rate
On the abdominal region a responder is a subject with a 2 log10/cm\^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time. On the inguinal region a responder is a subject with a 3 log10/cm\^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time.
Time frame: baseline, 10 minutes post-product application and 6 hours post-product application
Alternative Primary
10 minute log reduction
Time frame: Baseline and 10 minutes

Secondary outcomes

Reduction of Skin Flora 6 Hours Post-treatment
Log10/cm\^2 reduction of skin flora, relative to treatment day baseline, 6 hours post-treatment application
Time frame: 6 hours
Reduction of Skin Flora 10 Minutes Post-treatment
Log10/cm\^2 reduction of skin flora, relative to treatment day baseline (log10/cm\^2) at 10 minutes post-treatment application
Time frame: 10 minutes
Skin Flora Recovery 6-hours Post-treatment
Log10/cm\^2 recovery of skin flora at 6 hours following application of treatment
Time frame: 6 hours post-treatment
Skin Flora Recovery 10 Minutes Post-treatment
Log10/cm\^2 recovery of skin flora at 10 minutes following application of study treatments.
Time frame: 10 minute post-product application
Skin Flora Baseline for the Abdomen and Inguinal Region.
Log10/cm\^2 baseline skin flora for abdominal and inguinal regions
Time frame: Baseline
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
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.
Time frame: Baseline
Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
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
Time frame: 10 minutes post-treatment
Safety as Assessed by Skin Irritation Score
Skin irritation rating (0-3) scores for dryness, edema, erythema and rash; 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe.
Time frame: 6 hours post-treatment

Results

Posted Nov 23, 2020

Participant flow

Participant flow — Overall Study
Milestone	3M CHG/IPA Prep C - Abdominal	3M CHG/IPA Prep CH - Abdominal	ChloraPrep - Abdominal	Normal Saline - Abdominal	3M CHG/IPA Prep C - Inguinal	3M CHG/IPA Prep CH - Inguinal	ChloraPrep - Inguinal	Normal Saline - Inguinal
Started	343	344	347	104	242	244	248	74
Completed	196	202	196	59	208	209	219	61
Not completed	147	142	151	45	34	35	29	13
Withdrew: Did not meet treatment day baseline	147	141	150	45	33	35	29	12
Withdrew: Discontinued early due to compromised test sites	0	1	1	0	1	0	0	1

Outcome measures

PrimaryResponder Rate

On the abdominal region a responder is a subject with a 2 log10/cm\^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time. On the inguinal region a responder is a subject with a 3 log10/cm\^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time.

Time frame:: baseline, 10 minutes post-product application and 6 hours post-product application
Reported as:: Count of participants · Participants

Responder Rate
Participants	3M CHG/IPA Prep C - Abdominal	3M CHG/IPA Prep CH - Abdominal	ChloraPrep - Abdominal	Normal Saline - Abdominal	3M CHG/IPA Prep C - Inguinal	3M CHG/IPA Prep CH - Inguinal	ChloraPrep - Inguinal	Normal Saline - Inguinal
Responder Rate	159	165	163	5	81	98	116	1

Statistical analysis

3M CHG/IPA Prep C - Abdominal vs Normal Saline - Abdominal · Chi-squared · p = <0.0001
3M CHG/IPA Prep CH - Abdominal vs Normal Saline - Abdominal · Chi-squared · p = <0.0001
ChloraPrep - Abdominal vs Normal Saline - Abdominal · Chi-squared · p = <0.0001
3M CHG/IPA Prep C - Inguinal vs Normal Saline - Inguinal · Chi-squared · p = <0.0001
3M CHG/IPA Prep CH - Inguinal vs Normal Saline - Inguinal · Chi-squared · p = <0.0001
ChloraPrep - Inguinal vs Normal Saline - Inguinal · Chi-squared · p = <0.0001
3M CHG/IPA Prep C - Abdominal · Mean value: 81.1 · 95% CI 75.6 to 86.6
3M CHG/IPA Prep CH - Abdominal · Mean value: 81.7 · 95% CI 76.3 to 87.1
ChloraPrep - Abdominal · Mean value: 83.2 · 95% CI 77.9 to 88.4
3M CHG/IPA Prep C - Inguinal · Mean value: 38.9 · 95% CI 32.3 to 45.6
3M CHG/IPA Prep CH - Inguinal · Mean value: 46.9 · 95% CI 40.1 to 53.7
ChloraPrep - Inguinal · Mean value: 53.0 · 95% CI 46.3 to 59.6

PrimaryAlternative Primary

10 minute log reduction

Time frame:: Baseline and 10 minutes
Reported as:: Mean · log10/cm^2

Alternative Primary
log10/cm^2	3M CHG/IPA Prep C - Inguinal	3M CHG/IPA Prep CH - Inguinal	ChloraPrep - Inguinal
Alternative Primary	2.84 ± 1.19	2.99 ± 1.12	3.17 ± 1.24

Statistical analysis

3M CHG/IPA Prep C - Inguinal vs ChloraPrep - Inguinal · Mean difference (final values): -0.34 · 95% CI -0.57 to -0.103M CHG/IPA C - Inguinal minus ChloraPrep - Inguinal
3M CHG/IPA Prep CH - Inguinal vs ChloraPrep - Inguinal · Mean difference (final values): -0.18 · 97.5% CI -0.44 to 0.743M CHG/IPA CH - Inguinal minus ChloraPrep - Inguinal

SecondaryReduction of Skin Flora 6 Hours Post-treatment

Log10/cm\^2 reduction of skin flora, relative to treatment day baseline, 6 hours post-treatment application

Time frame:: 6 hours
Reported as:: Mean · log10/cm^2 skin flora

Reduction of Skin Flora 6 Hours Post-treatment
log10/cm^2 skin flora	3M CHG/IPA Prep C - Abdominal	3M CHG/IPA Prep CH - Abdominal	ChloraPrep - Abdominal	Normal Saline - Abdominal	3M CHG/IPA Prep C - Inguinal	3M CHG/IPA Prep CH - Inguinal	ChloraPrep - Inguinal	Normal Saline - Inguinal
Reduction of Skin Flora 6 Hours Post-treatment	2.83 ± 0.851	2.86 ± 0.899	2.83 ± 0.971	1.00 ± 0.971	3.46 ± 1.312	3.49 ± 1.329	3.69 ± 1.286	1.23 ± 0.732

Statistical analysis

3M CHG/IPA Prep C - Abdominal · Mean value: 2.83
3M CHG/IPA Prep CH - Abdominal · Mean value: 2.86
ChloraPrep - Abdominal · Mean value: 2.83
Normal Saline - Abdominal · Mean value: 1.00
3M CHG/IPA Prep C - Inguinal · Mean value: 3.46
3M CHG/IPA Prep CH - Inguinal · Mean value: 3.49
ChloraPrep - Inguinal · Mean value: 3.69
Normal Saline - Inguinal · Mean value: 1.23

SecondaryReduction of Skin Flora 10 Minutes Post-treatment

Log10/cm\^2 reduction of skin flora, relative to treatment day baseline (log10/cm\^2) at 10 minutes post-treatment application

Time frame:: 10 minutes
Reported as:: Mean · log10/cm^2 skin flora

Reduction of Skin Flora 10 Minutes Post-treatment
log10/cm^2 skin flora	3M CHG/IPA Prep C - Abdominal	3M CHG/IPA Prep CH - Abdominal	ChloraPrep - Abdominal	Normal Saline - Abdominal	3M CHG/IPA Prep C - Inguinal	3M CHG/IPA Prep CH - Inguinal	ChloraPrep - Inguinal	Normal Saline - Inguinal
Reduction of Skin Flora 10 Minutes Post-treatment	2.78 ± 0.935	2.73 ± 1.002	2.75 ± 0.973	0.76 ± 0.814	2.84 ± 1.191	2.99 ± 1.125	3.17 ± 1.243	1.01 ± 0.668

Statistical analysis

3M CHG/IPA Prep C - Abdominal · Mean value: 2.78
3M CHG/IPA Prep CH - Abdominal · Mean value: 2.73
ChloraPrep - Abdominal · Mean value: 2.75
Normal Saline - Abdominal · Mean value: 0.76
3M CHG/IPA Prep C - Inguinal · Mean value: 2.84
3M CHG/IPA Prep CH - Inguinal · Mean value: 2.99
ChloraPrep - Inguinal · Mean value: 3.17
Normal Saline - Inguinal · Mean value: 1.01

SecondarySkin Flora Recovery 6-hours Post-treatment

Log10/cm\^2 recovery of skin flora at 6 hours following application of treatment

Time frame:: 6 hours post-treatment
Reported as:: Mean · log10/cm^2 skin flora

Skin Flora Recovery 6-hours Post-treatment
log10/cm^2 skin flora	3M CHG/IPA Prep C - Abdominal	3M CHG/IPA Prep CH - Abdominal	ChloraPrep - Abdominal	Normal Saline - Abdominal	3M CHG/IPA Prep C - Inguinal	3M CHG/IPA Prep CH - Inguinal	ChloraPrep - Inguinal	Normal Saline - Inguinal
Skin Flora Recovery 6-hours Post-treatment	0.80 ± 0.840	0.74 ± 0.789	0.81 ± 0.935	2.65 ± 0.886	2.76 ± 1.202	2.73 ± 1.220	2.58 ± 1.182	4.85 ± 0.749

Statistical analysis

3M CHG/IPA Prep C - Abdominal · Mean value: 0.80
3M CHG/IPA Prep CH - Abdominal · Mean value: 0.74
ChloraPrep - Abdominal · Mean value: 0.81
Normal Saline - Abdominal · Mean value: 2.65
3M CHG/IPA Prep C - Inguinal · Mean value: 2.76
3M CHG/IPA Prep CH - Inguinal · Mean value: 2.73
ChloraPrep - Inguinal · Mean value: 2.58
Normal Saline - Inguinal · Mean value: 4.85

SecondarySkin Flora Recovery 10 Minutes Post-treatment

Log10/cm\^2 recovery of skin flora at 10 minutes following application of study treatments.

Time frame:: 10 minute post-product application
Reported as:: Mean · log10/cm^2 skin flora

Skin Flora Recovery 10 Minutes Post-treatment
log10/cm^2 skin flora	3M CHG/IPA Prep C - Abdominal	3M CHG/IPA Prep CH - Abdominal	ChloraPrep - Abdominal	Normal Saline - Abdominal	3M CHG/IPA Prep C - Inguinal	3M CHG/IPA Prep CH - Inguinal	ChloraPrep - Inguinal	Normal Saline - Inguinal
Skin Flora Recovery 10 Minutes Post-treatment	0.85 ± 0.947	0.88 ± 0.984	0.90 ± 0.938	2.88 ± 0.703	3.39 ± 1.096	3.21 ± 1.042	3.08 ± 1.137	5.08 ± 0.676

Statistical analysis

3M CHG/IPA Prep C - Abdominal · Mean value: 0.85
3M CHG/IPA Prep CH - Abdominal · Mean value: 0.87
ChloraPrep - Abdominal · Mean value: 0.89
Normal Saline - Abdominal · Mean value: 2.88
3M CHG/IPA Prep C - Inguinal · Mean value: 3.39
3M CHG/IPA Prep CH - Inguinal · Mean value: 3.21
ChloraPrep - Inguinal · Mean value: 3.08
Normal Saline - Inguinal · Mean value: 5.08

SecondarySkin Flora Baseline for the Abdomen and Inguinal Region.

Log10/cm\^2 baseline skin flora for abdominal and inguinal regions

Time frame:: Baseline
Reported as:: Mean · log10/cm^2 skin flora

Skin Flora Baseline for the Abdomen and Inguinal Region.
log10/cm^2 skin flora	3M CHG/IPA Prep C - Abdominal	3M CHG/IPA Prep CH - Abdominal	ChloraPrep - Abdominal	Normal Saline - Abdominal	3M CHG/IPA Prep C - Inguinal	3M CHG/IPA Prep CH - Inguinal	ChloraPrep - Inguinal	Normal Saline - Inguinal
Skin Flora Baseline for the Abdomen and Inguinal Region.	3.63 ± 0.460	3.61 ± 0.479	3.64 ± 0.487	3.64 ± 0.533	6.23 ± 0.604	6.21 ± 0.563	6.27 ± 0.618	6.09 ± 0.626

Statistical analysis

3M CHG/IPA Prep C - Abdominal · Mean value: 3.63
3M CHG/IPA Prep CH - Abdominal · Mean value: 3.61
ChloraPrep - Abdominal · Mean value: 3.64
Normal Saline - Abdominal · Mean value: 3.64
3M CHG/IPA Prep C - Inguinal · Mean value: 6.23
3M CHG/IPA Prep CH - Inguinal · Mean value: 6.22
ChloraPrep - Inguinal · Mean value: 6.27
Normal Saline - Inguinal · Mean value: 6.09

SecondarySafety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score

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.

Time frame:: Baseline
Reported as:: Number · participants

Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
participants	3M CHG/IPA Prep C - Abdominal	3M CHG/IPA Prep CH - Abdominal	ChloraPrep - Abdominal	Normal Saline - Abdominal	3M CHG/IPA Prep C - Inguinal	3M CHG/IPA Prep CH - Inguinal	ChloraPrep - Inguinal	Normal Saline - Inguinal
Dryness-No Reaction (0)	343	344	347	104	240	244	248	74
Dryness-Mild (1)	0	0	0	0	0	0	0	0
Dryness-Moderate (2)	0	0	0	0	0	0	0	0
Dryness-Severe (3)	0	0	0	0	0	0	0	0
Edema-No Reaction (0)	343	344	347	104	240	244	248	74
Edema-Mild (1)	0	0	0	0	0	0	0	0
Edema-Moderate (2)	0	0	0	0	0	0	0	0
Edema-Severe (3)	0	0	0	0	0	0	0	0
Erythema-No Reaction (0)	340	343	347	104	239	243	247	74
Erythema-Mild (1)	3	1	0	0	1	1	1	0
Erythema-Moderate (2)	0	0	0	0	0	0	0	0
Erythema-Severe (3)	0	0	0	0	0	0	0	0
Rash-No Reaction (0)	343	344	347	104	240	244	248	74
Rash-Mild (1)	0	0	0	0	0	0	0	0
Rash-Moderate (2)	0	0	0	0	0	0	0	0
Rash-Severe (3)	0	0	0	0	0	0	0	0

SecondarySafety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score

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

Time frame:: 10 minutes post-treatment
Reported as:: Number · participants

Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
participants	3M CHG/IPA Prep C - Abdominal	3M CHG/IPA Prep CH - Abdominal	ChloraPrep - Abdominal	Normal Saline - Abdominal	3M CHG/IPA Prep C - Inguinal	3M CHG/IPA Prep CH - Inguinal	ChloraPrep - Inguinal	Normal Saline - Inguinal
Dryness-No Reaction (0)	343	344	347	104	242	244	248	73
Dryness-Mild (1)	0	0	0	0	0	0	0	1
Dryness-Moderate (2)	0	0	0	0	0	0	0	0
Dryness-Severe (3)	0	0	0	0	0	0	0	0
Edema-No Reaction	343	344	347	104	242	244	247	74
Edema-Mild (1)	0	0	0	0	0	0	1	0
Edema-Moderate (2)	0	0	0	0	0	0	0	0
Edema-Severe (3)	0	0	0	0	0	0	0	0
Erythema-No Reaction (0)	341	343	345	104	240	242	243	73
Erythema-Mild (1)	2	1	2	0	2	2	5	1
Erythema-Moderate (2)	0	0	0	0	0	0	0	0
Erythema-Severe (3)	0	0	0	0	0	0	0	0
Rash-No Reaction (0)	343	344	347	104	242	244	248	74
Rash-Mild(1)	0	0	0	0	0	0	0	0
Rash-Moderate (2)	0	0	0	0	0	0	0	0
Rash-Severe (3)	0	0	0	0	0	0	0	0

SecondarySafety as Assessed by Skin Irritation Score

Skin irritation rating (0-3) scores for dryness, edema, erythema and rash; 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe.

Time frame:: 6 hours post-treatment
Reported as:: Count of participants · Participants

Safety as Assessed by Skin Irritation Score
Participants	3M CHG/IPA Prep C - Abdominal	3M CHG/IPA Prep CH - Abdominal	ChloraPrep - Abdominal	Normal Saline - Abdominal	3M CHG/IPA Prep C - Inguinal	3M CHG/IPA Prep CH - Inguinal	ChloraPrep - Inguinal	Normal Saline - Inguinal
Dryness-No Reaction (0)	334	330	336	101	240	240	241	73
Dryness-Mild (1)	9	14	10	3	2	4	7	1
Dryness-Moderate (2)	0	0	1	0	0	0	0	0
Dryness-Severe (3)	0	0	0	0	0	0	0	0
Edema-No Reaction (0)	343	344	347	104	242	244	248	74
Edema-Mild (1)	0	0	0	0	0	0	0	0
Edema-Moderate (2)	0	0	0	0	0	0	0	0
Edema-Severe (3)	0	0	0	0	0	0	0	0
Erythema-No Reaction (0)	310	310	332	98	227	220	236	72
Erythema-Mild (1)	32	33	15	6	15	24	12	2
Erythema-Moderate (2)	1	1	0	0	0	0	0	0
Erythema-Severe (3)	0	0	0	0	0	0	0	0
Rash-No Reaction (0)	339	337	342	103	230	231	229	66
Rash-Mild (1)	4	7	5	1	12	13	19	8
Rash-Moderate (2)	0	0	0	0	0	0	0	0
Rash-Severe (3)	0	0	0	0	0	0	0	0

Adverse events

Collected over Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
3M CHG/IPA Prep C - Abdominal	0/343 (0%)	0/343 (0%)	2/343 (0.6%)
3M CHG/IPA Prep CH - Abdominal	0/344 (0%)	0/344 (0%)	3/344 (0.9%)
ChloraPrep - Abdominal	0/347 (0%)	0/347 (0%)	1/347 (0.3%)
Normal Saline - Abdominal	0/104 (0%)	0/104 (0%)	0/104 (0%)
3M CHG/IPA Prep C - Inguinal	0/242 (0%)	0/242 (0%)	2/242 (0.8%)
3M CHG/IPA Prep CH - Inguinal	0/244 (0%)	0/244 (0%)	3/244 (1.2%)
ChloraPrep - Inguinal	0/248 (0%)	0/248 (0%)	0/248 (0%)
Normal Saline - Inguinal	0/74 (0%)	0/74 (0%)	0/74 (0%)

Most frequent other events

Most frequent other events
Event	3M CHG/IPA Prep C - Abdominal	3M CHG/IPA Prep CH - Abdominal	ChloraPrep - Abdominal	Normal Saline - Abdominal	3M CHG/IPA Prep C - Inguinal	3M CHG/IPA Prep CH - Inguinal	ChloraPrep - Inguinal	Normal Saline - Inguinal
AnticipatedSkin and subcutaneous tissue disorders	2/343	2/344	1/347	0/104	2/242	3/244	0/248	0/74
Mild severitySkin and subcutaneous tissue disorders	1/343	2/344	1/347	0/104	1/242	2/244	0/248	0/74
Probably related to productSkin and subcutaneous tissue disorders	2/343	2/344	1/347	0/104	1/242	2/244	0/248	0/74
Moderate severitySkin and subcutaneous tissue disorders	1/343	1/344	0/347	0/104	1/242	1/244	0/248	0/74
Possibly related to productsSkin and subcutaneous tissue disorders	0/343	0/344	0/347	0/104	1/242	0/244	0/248	0/74
Not related to productSkin and subcutaneous tissue disorders	0/343	1/344	0/347	0/104	0/242	1/244	0/248	0/74
UnexpectedSkin and subcutaneous tissue disorders	0/343	1/344	0/347	0/104	0/242	0/244	0/248	0/74

Baseline characteristics

Subjects with average screening day baseline counts of greater than or equal to 3.00 log10 CFU/cm2 bilaterally on the abdominal region and/or greater than or equal to 5.00 log10 CFU/cm2 bilaterally on the inguinal region were included in the analysis.

Age, Categorical
Age, Categorical(Participants)	3M CHG/IPA Prep C - Abdominal	3M CHG/IPA Prep CH - Abdominal	ChloraPrep - Abdominal	Saline - Abdominal	3M CHG/IPA Prep C - Inguinal	3M CHG/IPA Prep CH - Inguinal	ChloraPrep - Inguinal	Saline - Inguinal	Total
<=18 years	0	0	0	0	0	0	0	0	0
Between 18 and 65 years	333	338	332	102	236	236	245	73	1895
>=65 years	10	6	15	2	6	8	3	1	51

Sex: Female, Male
Sex: Female, Male(Participants)	3M CHG/IPA Prep C - Abdominal	3M CHG/IPA Prep CH - Abdominal	ChloraPrep - Abdominal	Saline - Abdominal	3M CHG/IPA Prep C - Inguinal	3M CHG/IPA Prep CH - Inguinal	ChloraPrep - Inguinal	Saline - Inguinal	Total
Female	92	99	105	32	56	64	67	23	538
Male	251	245	242	72	186	180	181	51	1408

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	3M CHG/IPA Prep C - Abdominal	3M CHG/IPA Prep CH - Abdominal	ChloraPrep - Abdominal	Saline - Abdominal	3M CHG/IPA Prep C - Inguinal	3M CHG/IPA Prep CH - Inguinal	ChloraPrep - Inguinal	Saline - Inguinal	Total
American Indian or Alaska Native	5	6	3	2	3	4	5	0	28
Asian	8	8	9	1	5	8	7	2	48
Black or African American	6	2	7	1	1	1	0	0	18
Hispanic / Latino	13	9	15	5	9	11	14	0	76
Native Hawaiin or Other Pacific Islander	3	2	1	0	2	0	2	0	10
White	308	320	316	96	222	222	221	71	1776
Other	7	3	3	1	2	4	6	2	28

Region of Enrollment
Region of Enrollment(participants)	3M CHG/IPA Prep C - Abdominal	3M CHG/IPA Prep CH - Abdominal	ChloraPrep - Abdominal	Saline - Abdominal	3M CHG/IPA Prep C - Inguinal	3M CHG/IPA Prep CH - Inguinal	ChloraPrep - Inguinal	Saline - Inguinal	Total
United States	343	344	347	104	242	244	248	74	973

Study locations

1 site

BioScience Laboratories, Inc.
Bozeman, Montana 59718, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02203591
Lead sponsor: 3M
Responsible party: Sponsor
First posted: Jul 30, 2014
Start date: Jul 2014
Primary completion: Mar 2015
Completion: Mar 2015
Results posted: Nov 23, 2020
Last update: Nov 23, 2020

Study contacts

Jamie Miller, ADN

principal investigator · Independent Consultant

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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