Healthy
Conditions
Brief summary
Pilot study to evaluate and compare activity of preoperative preparation with comparator
Detailed description
Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Various application times were evaluated. Efficacy was assess using TFM criteria.
Interventions
DRUGCHG
Varied application times
Sponsors
Medline Industries
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy * No dermatological conditions
Exclusion criteria
* Sensitivity to CHG * Sensitivity to natural latex rubber or adhesive skin products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Log Reduction of Bacterial Flora on the Abdomen and Groin | 10 min, 6 hr and 8 hr | Evaluate the Log Reduction of normal flora at various timepoints. |
Participant flow
Recruitment details
Upon achieving sufficient microbial growth prior to product application on either the abdomen, groin or both abdomen and groin regions, sites of the participant were then randomized to receive one or two products for evaluation for up to 4 sites. Differences in the number of participants is based on microbial qualifications.
Pre-assignment details
Participants were randomized to be treated with at least 2 treatments/ Arms (out of 3) at the same time for both groin and abdomen. Total numbers represent sites not the individual number of participants.
Participants by arm
| Arm | Count |
|---|---|
| CHG 1, CHG 2, Comparator CHG Participants could receive up to 2 different treatments at the same time. Treatments included CHG at 1 min, CHG at 2 min or Comparator CHG. | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | CHG 1, CHG 2, Comparator CHG |
|---|---|
| Age, Customized Age | 48 years |
| Region of Enrollment United States | 33 Sites exposed |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
Primary
Log Reduction of Bacterial Flora on the Abdomen and Groin
Evaluate the Log Reduction of normal flora at various timepoints.
Time frame: 10 min, 6 hr and 8 hr
Population: Determine 70% responder rates
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CHG 1 Min Abdomen | Log Reduction of Bacterial Flora on the Abdomen and Groin | 6 hour | 2.6 Log10 Reductions | Standard Deviation 1.3 |
| CHG 1 Min Abdomen | Log Reduction of Bacterial Flora on the Abdomen and Groin | 10 min | 1.9 Log10 Reductions | Standard Deviation 1.6 |
| CHG 1 Min Abdomen | Log Reduction of Bacterial Flora on the Abdomen and Groin | 8 hour | 2.6 Log10 Reductions | Standard Deviation 1 |
| CHG 2 Min Abdomen | Log Reduction of Bacterial Flora on the Abdomen and Groin | 6 hour | 2.5 Log10 Reductions | Standard Deviation 1.4 |
| CHG 2 Min Abdomen | Log Reduction of Bacterial Flora on the Abdomen and Groin | 10 min | 2.0 Log10 Reductions | Standard Deviation 1.5 |
| CHG 2 Min Abdomen | Log Reduction of Bacterial Flora on the Abdomen and Groin | 8 hour | 2.2 Log10 Reductions | Standard Deviation 1.6 |
| Comparator CHG Abdomen | Log Reduction of Bacterial Flora on the Abdomen and Groin | 6 hour | 1.7 Log10 Reductions | Standard Deviation 1.6 |
| Comparator CHG Abdomen | Log Reduction of Bacterial Flora on the Abdomen and Groin | 10 min | 1.3 Log10 Reductions | Standard Deviation 1.8 |
| Comparator CHG Abdomen | Log Reduction of Bacterial Flora on the Abdomen and Groin | 8 hour | 1.4 Log10 Reductions | Standard Deviation 1.2 |
| CHG 1 Min Groin | Log Reduction of Bacterial Flora on the Abdomen and Groin | 6 hour | 2.3 Log10 Reductions | Standard Deviation 0.8 |
| CHG 1 Min Groin | Log Reduction of Bacterial Flora on the Abdomen and Groin | 10 min | 1.9 Log10 Reductions | Standard Deviation 0.6 |
| CHG 1 Min Groin | Log Reduction of Bacterial Flora on the Abdomen and Groin | 8 hour | 2.5 Log10 Reductions | Standard Deviation 0.9 |
| CHG 2 Min Groin | Log Reduction of Bacterial Flora on the Abdomen and Groin | 6 hour | 2.8 Log10 Reductions | Standard Deviation 1.2 |
| CHG 2 Min Groin | Log Reduction of Bacterial Flora on the Abdomen and Groin | 10 min | 2.4 Log10 Reductions | Standard Deviation 1.1 |
| CHG 2 Min Groin | Log Reduction of Bacterial Flora on the Abdomen and Groin | 8 hour | 2.7 Log10 Reductions | Standard Deviation 0.8 |
| Comparator CHG Groin | Log Reduction of Bacterial Flora on the Abdomen and Groin | 10 min | 2.1 Log10 Reductions | Standard Deviation 1.1 |
| Comparator CHG Groin | Log Reduction of Bacterial Flora on the Abdomen and Groin | 8 hour | 2.2 Log10 Reductions | Standard Deviation 1.1 |
| Comparator CHG Groin | Log Reduction of Bacterial Flora on the Abdomen and Groin | 6 hour | 1.9 Log10 Reductions | Standard Deviation 0.8 |