Surgical Skin Preparation
Conditions
Brief summary
A single 2% topical application of ReadyPrep® CHG was applied on either the abdomen (Treatment-1) or the groin (Treatment-2) whereas Treatment-3 consisted of a control treatment where the same procedure as Treatment-1 and -2 was performed, but without the topical application of ReadyPrep® CHG. The treatments were separated by a wash-out of 7 calendar days.
Interventions
DRUGChlorhexidine Gluconate
2% CHG
Sponsors
Medline Industries
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
laboratory-blinded, 3-period, 3-sequence, crossover study
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects were male or female, aged ≥ 18 and ≤ 60 years (inclusive). The main inclusion criteria were: * non- or ex-smokers * body mass index (BMI) ≥19.00 kg/m2 and ≤32.00 kg/m2 and a body weight ≥ 55 kg * negative pregnancy test for female subjects * healthy according to medical history, complete physical examination (including vital signs and skin examination) and laboratory tests (general biochemistry, hematology and urinalysis)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Plasma Levels of Chlorexidine Following Systemic Exposure After a Single Topical Application of CHG. | Up to 24 hours after product application | A total of 12 blood samples were collected (one tube of 6 mL each) at various time points up before and after product application in each study period and analyzed for plasma levels of chlorhexidine. Blood samples were collected at 10, 2 and 0.5 hours prior to each treatment, and 1, 2, 3, 4, 5, 6, 8, and 12 hours following each treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With of Treatment Emergent Adverse Events. | Up to 24 hours after product application, overall, up to 3 weeks | Number of subjects with treatment related adverse events as assessed by System Organ Class (SOC) using the Medical Dictionary for Regulatory Activities (MedDRA). |
Countries
United States
Participant flow
Recruitment details
12 subjects were enrolled to participate in a 3-period, 3-sequence crossover study design
Pre-assignment details
Each of the 12 subjects were scheduled to receive one of each treatment and randomized to what period they would receive each.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All 12 study participants are included | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Customized | 27 years STANDARD_DEVIATION 11 |
| Body Mass Index (kg/m2) | 26 kg/m^2 STANDARD_DEVIATION 3.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height (cm) | 169.8 cm STANDARD_DEVIATION 8.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 6 Participants |
| Weight (kg) | 75.6 weight in kg STANDARD_DEVIATION 14.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 10 | 0 / 11 |
| other Total, other adverse events | 1 / 12 | 1 / 10 | 1 / 11 |
| serious Total, serious adverse events | 0 / 12 | 0 / 10 | 0 / 11 |
Outcome results
Primary
Number of Subjects With Plasma Levels of Chlorexidine Following Systemic Exposure After a Single Topical Application of CHG.
A total of 12 blood samples were collected (one tube of 6 mL each) at various time points up before and after product application in each study period and analyzed for plasma levels of chlorhexidine. Blood samples were collected at 10, 2 and 0.5 hours prior to each treatment, and 1, 2, 3, 4, 5, 6, 8, and 12 hours following each treatment.
Time frame: Up to 24 hours after product application
Population: There was no statistical analysis planned on the PK results of this study. Results were reported as is. Study was completed as a 3-period, 3-sequence crossover therefore not all arms were analyzed with same amount of participants due to drop out.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abdominal Application of 2% CHG | Number of Subjects With Plasma Levels of Chlorexidine Following Systemic Exposure After a Single Topical Application of CHG. | 0 Participants |
| Groin Application of 2% CHG | Number of Subjects With Plasma Levels of Chlorexidine Following Systemic Exposure After a Single Topical Application of CHG. | 0 Participants |
| Control Treatment With no Application | Number of Subjects With Plasma Levels of Chlorexidine Following Systemic Exposure After a Single Topical Application of CHG. | 0 Participants |
Secondary
Number of Subjects With of Treatment Emergent Adverse Events.
Number of subjects with treatment related adverse events as assessed by System Organ Class (SOC) using the Medical Dictionary for Regulatory Activities (MedDRA).
Time frame: Up to 24 hours after product application, overall, up to 3 weeks
Population: Study was completed as a 3-period, 3-sequence crossover therefore not all arms were analyzed with same amount of participants due to drop out.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abdominal Application of 2% CHG | Number of Subjects With of Treatment Emergent Adverse Events. | 1 Participants |
| Groin Application of 2% CHG | Number of Subjects With of Treatment Emergent Adverse Events. | 1 Participants |
| Control Treatment With no Application | Number of Subjects With of Treatment Emergent Adverse Events. | 1 Participants |