Surgery
Conditions
Keywords
Preoperative surgical skin preparation
Brief summary
Pilot study to evaluate and compare activity of CHG preoperative preparation with comparator CHG
Detailed description
Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Efficacy was assess using Tentative Final Monograph (TFM) criteria.
Interventions
DRUGCHG
Single application
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 Change in Bacterial Flora on Abdomen and Groin | 10 min, 6 hr and 8 hr | Change was calculated as the baseline time point minus the later time points over an 8 hour period. |
Participant flow
Recruitment details
Upon achieving sufficient microbial growth prior to product application on either the abdomen and groin regions, sites of the participant were then randomized to received two products for an evaluation or up to 4 sites.
Pre-assignment details
Participants were randomized to be treated with at least 2 treatments/ Arms at the same time for both groin and abdomen. Total numbers represent participants.
Participants by arm
| Arm | Count |
|---|---|
| CHG 3 Min, Comparator CHG CHG applied for 3 min, Comparator CHG applied per instructions. | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | CHG 3 Min, Comparator CHG |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 56 years |
| Region of Enrollment Romania | 14 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Log Change in Bacterial Flora on Abdomen and Groin
Change was calculated as the baseline time point minus the later time points over an 8 hour period.
Time frame: 10 min, 6 hr and 8 hr
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| CHG 3 Min Abdomen | Log Change in Bacterial Flora on Abdomen and Groin | 10 min | 2.9 Log (CFU) |
| CHG 3 Min Abdomen | Log Change in Bacterial Flora on Abdomen and Groin | 8 hour | 2.9 Log (CFU) |
| CHG 3 Min Abdomen | Log Change in Bacterial Flora on Abdomen and Groin | 6 hour | 2.9 Log (CFU) |
| CHG 3 Min Groin | Log Change in Bacterial Flora on Abdomen and Groin | 10 min | 3.7 Log (CFU) |
| CHG 3 Min Groin | Log Change in Bacterial Flora on Abdomen and Groin | 8 hour | 4.6 Log (CFU) |
| CHG 3 Min Groin | Log Change in Bacterial Flora on Abdomen and Groin | 6 hour | 3.9 Log (CFU) |
| Comparator CHG Abdomen | Log Change in Bacterial Flora on Abdomen and Groin | 6 hour | 2.5 Log (CFU) |
| Comparator CHG Abdomen | Log Change in Bacterial Flora on Abdomen and Groin | 10 min | 2.3 Log (CFU) |
| Comparator CHG Abdomen | Log Change in Bacterial Flora on Abdomen and Groin | 8 hour | 2.3 Log (CFU) |
| Comparator CHG Groin | Log Change in Bacterial Flora on Abdomen and Groin | 10 min | 3.0 Log (CFU) |
| Comparator CHG Groin | Log Change in Bacterial Flora on Abdomen and Groin | 8 hour | 3.3 Log (CFU) |
| Comparator CHG Groin | Log Change in Bacterial Flora on Abdomen and Groin | 6 hour | 3.3 Log (CFU) |