Surgery
Conditions
Keywords
Surgical Skin Preparation
Brief summary
Pilot study to evaluate and compare activity of investigational preoperative preparation (2% CHG) with comparator (2% CHG).
Detailed description
Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Various application times were evaluated. Efficacy was assess using the Tentative Final Monograph (TFM) criteria.
Interventions
DRUGCHG
Varied application times
Sponsors
Medline Industries
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 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 Abdomen and Groin Sites | 10 min, 6 hr and 8 hr | Evaluate the Log Reduction of Normal Flora at various sites and 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 4) at the same time for both groin and abdomen. Numbers represent the total sites tested.
Participants by arm
| Arm | Count |
|---|---|
| CHG 1, CHG 2, CHG 3, Comparator CHG Participants could receive up to 2 different treatments at the same time. Treatments included CHG at 1 min, CHG at 2 min, CHG at 3 min or Comparator CHG. | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | CHG 1, CHG 2, CHG 3, Comparator CHG |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants |
| Age, Continuous | 36 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 18 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 34 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 14 | 0 / 13 | 0 / 14 |
| other Total, other adverse events | 0 / 13 | 0 / 14 | 0 / 13 | 0 / 14 |
| serious Total, serious adverse events | 0 / 13 | 0 / 14 | 0 / 13 | 0 / 14 |
Outcome results
Primary
Log Reduction of Bacterial Flora on Abdomen and Groin Sites
Evaluate the Log Reduction of Normal Flora at various sites and timepoints
Time frame: 10 min, 6 hr and 8 hr
Population: The data represents the number of sites (abdomen/groin) tested.
| Arm | Measure | Group | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|---|
| CHG 1 Min Abdomen | Log Reduction of Bacterial Flora on Abdomen and Groin Sites | 6 hour | 2.0 Log 10 Reduction | Standard Deviation 0.86 |
| CHG 1 Min Abdomen | Log Reduction of Bacterial Flora on Abdomen and Groin Sites | 8 hour | 1.9 Log 10 Reduction | Standard Deviation 0.76 |
| CHG 1 Min Abdomen | Log Reduction of Bacterial Flora on Abdomen and Groin Sites | 10 min | 2.6 Log 10 Reduction | Standard Deviation 0.65 |
| CHG 1 Min Groin | Log Reduction of Bacterial Flora on Abdomen and Groin Sites | 10 min | 3.4 Log 10 Reduction | Standard Deviation 0.85 |
| CHG 1 Min Groin | Log Reduction of Bacterial Flora on Abdomen and Groin Sites | 6 hour | 2.7 Log 10 Reduction | Standard Deviation 0.67 |
| CHG 1 Min Groin | Log Reduction of Bacterial Flora on Abdomen and Groin Sites | 8 hour | 2.9 Log 10 Reduction | Standard Deviation 0.38 |
| CHG 2 Min Abdomen | Log Reduction of Bacterial Flora on Abdomen and Groin Sites | 8 hour | 2.4 Log 10 Reduction | Standard Deviation 1 |
| CHG 2 Min Abdomen | Log Reduction of Bacterial Flora on Abdomen and Groin Sites | 6 hour | 2.4 Log 10 Reduction | Standard Deviation 0.8 |
| CHG 2 Min Abdomen | Log Reduction of Bacterial Flora on Abdomen and Groin Sites | 10 min | 2.7 Log 10 Reduction | Standard Deviation 0.6 |
| CHG 2 Min Groin | Log Reduction of Bacterial Flora on Abdomen and Groin Sites | 6 hour | 2.9 Log 10 Reduction | Standard Deviation 1.13 |
| CHG 2 Min Groin | Log Reduction of Bacterial Flora on Abdomen and Groin Sites | 8 hour | 3.05 Log 10 Reduction | Standard Deviation 0.83 |
| CHG 2 Min Groin | Log Reduction of Bacterial Flora on Abdomen and Groin Sites | 10 min | 4.2 Log 10 Reduction | Standard Deviation 1.3 |
| CHG 3 Min Abdomen | Log Reduction of Bacterial Flora on Abdomen and Groin Sites | 8 hour | 1.9 Log 10 Reduction | Standard Deviation 0.67 |
| CHG 3 Min Abdomen | Log Reduction of Bacterial Flora on Abdomen and Groin Sites | 6 hour | 2.4 Log 10 Reduction | Standard Deviation 0.81 |
| CHG 3 Min Abdomen | Log Reduction of Bacterial Flora on Abdomen and Groin Sites | 10 min | 2.8 Log 10 Reduction | Standard Deviation 0.46 |
| CHG 3 Min Groin | Log Reduction of Bacterial Flora on Abdomen and Groin Sites | 8 hour | 3.2 Log 10 Reduction | Standard Deviation 0.8 |
| CHG 3 Min Groin | Log Reduction of Bacterial Flora on Abdomen and Groin Sites | 6 hour | 3.5 Log 10 Reduction | Standard Deviation 0.95 |
| CHG 3 Min Groin | Log Reduction of Bacterial Flora on Abdomen and Groin Sites | 10 min | 4.3 Log 10 Reduction | Standard Deviation 1.2 |
| Comparator CHG Abdomen | Log Reduction of Bacterial Flora on Abdomen and Groin Sites | 8 hour | 1.6 Log 10 Reduction | Standard Deviation 0.94 |
| Comparator CHG Abdomen | Log Reduction of Bacterial Flora on Abdomen and Groin Sites | 10 min | 2.6 Log 10 Reduction | Standard Deviation 0.71 |
| Comparator CHG Abdomen | Log Reduction of Bacterial Flora on Abdomen and Groin Sites | 6 hour | 1.9 Log 10 Reduction | Standard Deviation 0.64 |
| Comparator CHG Groin | Log Reduction of Bacterial Flora on Abdomen and Groin Sites | 8 hour | 2.5 Log 10 Reduction | Standard Deviation 0.94 |
| Comparator CHG Groin | Log Reduction of Bacterial Flora on Abdomen and Groin Sites | 10 min | 3.1 Log 10 Reduction | Standard Deviation 0.79 |
| Comparator CHG Groin | Log Reduction of Bacterial Flora on Abdomen and Groin Sites | 6 hour | 2.7 Log 10 Reduction | Standard Deviation 1 |