Surgery
Conditions
Keywords
Preoperative surgical skin preparation
Brief summary
Evaluate the effects of Chlorhexidine Gluconate (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 areas post Chlorhexidine Gluconate (CHG) application.
Interventions
DRUGChlorhexidine gluconate
2% CHG solution on cloth
DRUGDynaHex-2
2% CHG solution
OTHERVehicle
Excipients of CHG product only
Sponsors
Medline Industries
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Males or Females * 18 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 |
|---|---|---|
| Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin | 10 minutes, 6 hours, 8 hours | Log10 reduction in bacteria on the skin evaluated at 10 minutes, 6 hours and 8 hours after treatment. Responder rates (%) are the percentage of sites identified that produced a 2-Log and 3-Log reduction from baseline for abdomen and groin sites respectively. |
Countries
Romania
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 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. | 340 |
| Total | 340 |
Baseline characteristics
| Characteristic | CHG, Vehicle, Comparator CHG |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 24 Participants |
| Age, Categorical Between 18 and 65 years | 315 Participants |
| Age, Continuous | 38 years |
| Region of Enrollment Romania | 340 participants |
| Sex: Female, Male Female | 182 Participants |
| Sex: Female, Male Male | 158 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 284 | 0 / 56 | 0 / 281 | 0 / 290 | 0 / 56 | 0 / 294 |
| serious Total, serious adverse events | 0 / 284 | 0 / 56 | 0 / 281 | 0 / 290 | 0 / 56 | 0 / 294 |
Outcome results
Primary
Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin
Log10 reduction in bacteria on the skin evaluated at 10 minutes, 6 hours and 8 hours after treatment. Responder rates (%) are the percentage of sites identified that produced a 2-Log and 3-Log reduction from baseline for abdomen and groin sites respectively.
Time frame: 10 minutes, 6 hours, 8 hours
Population: Number of participants involved in the analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CHG 3 Min Abdomen | Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin | 6 hours | 100 Percent of sites |
| CHG 3 Min Abdomen | Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin | 8 hours | 99 Percent of sites |
| CHG 3 Min Abdomen | Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin | 10 min | 78 Percent of sites |
| CHG 3 Min Groin | Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin | 6 hours | 100 Percent of sites |
| CHG 3 Min Groin | Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin | 8 hours | 100 Percent of sites |
| CHG 3 Min Groin | Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin | 10 min | 84 Percent of sites |
| Vehicle Abdomen | Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin | 8 hours | 96 Percent of sites |
| Vehicle Abdomen | Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin | 10 min | 54 Percent of sites |
| Vehicle Abdomen | Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin | 6 hours | 96 Percent of sites |
| Vehicle Groin | Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin | 10 min | 56 Percent of sites |
| Vehicle Groin | Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin | 6 hours | 100 Percent of sites |
| Vehicle Groin | Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin | 8 hours | 100 Percent of sites |
| Comparator CHG Abdomen | Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin | 8 hours | 98 Percent of sites |
| Comparator CHG Abdomen | Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin | 10 min | 72 Percent of sites |
| Comparator CHG Abdomen | Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin | 6 hours | 99 Percent of sites |
| Comparator CHG Groin | Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin | 6 hours | 100 Percent of sites |
| Comparator CHG Groin | Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin | 10 min | 73 Percent of sites |
| Comparator CHG Groin | Responder Rates (%) of Sites Identified for Bacterial Reduction on the Abdomen and Groin | 8 hours | 100 Percent of sites |