Surgery
Conditions
Keywords
Preoperative surgical skin preparation
Brief summary
Evaluate the effects of CHG cloth on the reduction of bacteria on the skin.
Detailed description
Examine the antimicrobial cloth effects on normal flora bacteria of the abdomen and groin area post CHG application.
Interventions
DRUGChlorhexidine Gluconate
comparison with other CHG products
OTHERVehicle
Excipients of CHG product only.
DRUGDynaHex-2
2% CHG solution
Sponsors
Medline Industries
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Males or Females * 16 years of age or older * Signed informed consent * Good Health * Six inches of abdomen and groin areas without tattoos, or skin disorders
Exclusion criteria
* Dermatological Conditions * Sensitivity to latex * Sensitivity to CHG
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites | 10 minutes to 8 hours | Percent of abdomen and groin sites that achieve a 2-Log or 3-Log reduction respectively of bacterial flora from baseline. Note: The number of participants in each treatment group (abdomen and/or groin) can vary depending on whether participants achieved qualifying microbial levels on the abdomen and groin at baseline. |
Countries
United States
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 4 sites. Differences in the number of participants is based on microbial qualification.
Pre-assignment details
The sites of the participant were tested for microbial activity after product application. In some instances, more than one product could have been applied to a participant but only one product per site (groin and/or abdomen sites). Up to 4 sites could be treated : 1) both groin and abdomen, 2) only the groin or 3) only the abdomen.
Participants by arm
| Arm | Count |
|---|---|
| CHG, Vehicle, Comparator CHG Single applications of products. 3 min application for CHG and vehicle. Comparator CHG applied according to instructions. | 879 |
| Total | 879 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Abdomen | Did not qualify | 333 | 54 | 339 |
| Groin | Did not qualify | 183 | 30 | 177 |
Baseline characteristics
| Characteristic | CHG, Vehicle, Comparator CHG |
|---|---|
| Age, Categorical <=18 years | 13 Participants |
| Age, Categorical >=65 years | 37 Participants |
| Age, Categorical Between 18 and 65 years | 829 Participants |
| Age, Continuous | 35 years |
| Region of Enrollment United States | 879 participants |
| Sex: Female, Male Female | 281 Participants |
| Sex: Female, Male Male | 598 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 16 / 755 | 4 / 136 | 8 / 753 |
| serious Total, serious adverse events | 0 / 755 | 0 / 136 | 0 / 753 |
Outcome results
Primary
Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites
Percent of abdomen and groin sites that achieve a 2-Log or 3-Log reduction respectively of bacterial flora from baseline. Note: The number of participants in each treatment group (abdomen and/or groin) can vary depending on whether participants achieved qualifying microbial levels on the abdomen and groin at baseline.
Time frame: 10 minutes to 8 hours
Population: Participants received 1 or 2 products on up to 2 abdomen and 2 groin sites, 2 abdomen only sites or 2 groin sites only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CHG Abdomen | Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites | 6 hours | 99 % of Treated Sites |
| CHG Abdomen | Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites | 10 min | 80 % of Treated Sites |
| CHG Abdomen | Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites | 8 hours | 98 % of Treated Sites |
| CHG Groin | Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites | 6 hours | 100 % of Treated Sites |
| CHG Groin | Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites | 10 min | 75 % of Treated Sites |
| CHG Groin | Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites | 8 hours | 100 % of Treated Sites |
| Vehicle Abdomen | Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites | 6 hours | 97 % of Treated Sites |
| Vehicle Abdomen | Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites | 10 min | 86 % of Treated Sites |
| Vehicle Abdomen | Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites | 8 hours | 97 % of Treated Sites |
| Vehicle Groin | Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites | 6 hours | 100 % of Treated Sites |
| Vehicle Groin | Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites | 10 min | 65 % of Treated Sites |
| Vehicle Groin | Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites | 8 hours | 100 % of Treated Sites |
| Comparator Abdomen | Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites | 6 hours | 96 % of Treated Sites |
| Comparator Abdomen | Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites | 10 min | 81 % of Treated Sites |
| Comparator Abdomen | Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites | 8 hours | 96 % of Treated Sites |
| Comparator Groin | Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites | 10 min | 68 % of Treated Sites |
| Comparator Groin | Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites | 8 hours | 100 % of Treated Sites |
| Comparator Groin | Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites | 6 hours | 100 % of Treated Sites |