Trial Outcomes & Findings for Vaginal Prep Solutions to Reduce Bacteria Colony Counts in Patients Having a Vaginal Surgery (NCT NCT03854370)
NCT ID: NCT03854370
Last Updated: 2024-10-30
Results Overview
anaerobic culture colony counts - change in anaerobic colony counts from prior to surgical prep to 10 minutes after surgical prep
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
2 timepoints: prior to surgical prep, and 10 min after surgical prep
Results posted on
2024-10-30
Participant Flow
Participant milestones
| Measure |
Baby Shampoo
Baby shampoo used for surgical site prep
Baby shampoo: baby shampoo will be used to prepare the surgical site prior to incision
|
Peridex (Chlorhexidine)
Peridex used for surgical site prep
Peridex: Peridex (Chlorhexidine) will be used to prepare the surgical site prior to incision
|
TechniCare (Chloroxynel)
TechniCare used for surgical site prep
TechniCare: TechniCare (chloroxynel) will be used to prepare the surgical site prior to incision
|
Betadine (Povidone- Iodine)
Betadine used for surgical site prep
Betadine: Betadine (Povidone- iodine) will be used to prepare the surgical site prior to incision
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
7
|
10
|
|
Overall Study
COMPLETED
|
8
|
8
|
6
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Baby Shampoo
Baby shampoo used for surgical site prep
Baby shampoo: baby shampoo will be used to prepare the surgical site prior to incision
|
Peridex (Chlorhexidine)
Peridex used for surgical site prep
Peridex: Peridex (Chlorhexidine) will be used to prepare the surgical site prior to incision
|
TechniCare (Chloroxynel)
TechniCare used for surgical site prep
TechniCare: TechniCare (chloroxynel) will be used to prepare the surgical site prior to incision
|
Betadine (Povidone- Iodine)
Betadine used for surgical site prep
Betadine: Betadine (Povidone- iodine) will be used to prepare the surgical site prior to incision
|
|---|---|---|---|---|
|
Overall Study
samples not collected
|
1
|
1
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Baby Shampoo
n=8 Participants
Baby shampoo used for surgical site prep
Baby shampoo: baby shampoo will be used to prepare the surgical site prior to incision
|
Peridex (Chlorhexidine)
n=8 Participants
Peridex used for surgical site prep
Peridex: Peridex (Chlorhexidine) will be used to prepare the surgical site prior to incision
|
TechniCare (Chloroxynel)
n=6 Participants
TechniCare used for surgical site prep
TechniCare: TechniCare (chloroxynel) will be used to prepare the surgical site prior to incision
|
Betadine (Povidone- Iodine)
n=9 Participants
Betadine used for surgical site prep
Betadine: Betadine (Povidone- iodine) will be used to prepare the surgical site prior to incision
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
Age
|
39.4 years
STANDARD_DEVIATION 8.7 • n=8 Participants
|
44.9 years
STANDARD_DEVIATION 8.7 • n=8 Participants
|
44.0 years
STANDARD_DEVIATION 10.2 • n=6 Participants
|
46.8 years
STANDARD_DEVIATION 17.3 • n=9 Participants
|
43.6 years
STANDARD_DEVIATION 10.9 • n=31 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
6 Participants
n=6 Participants
|
9 Participants
n=9 Participants
|
31 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=31 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
8 participants
n=8 Participants
|
8 participants
n=8 Participants
|
6 participants
n=6 Participants
|
9 participants
n=9 Participants
|
31 participants
n=31 Participants
|
|
Body Mass Index
|
31.7 kg/m^2
STANDARD_DEVIATION 1.5 • n=8 Participants
|
31.0 kg/m^2
STANDARD_DEVIATION 7.3 • n=8 Participants
|
27.0 kg/m^2
STANDARD_DEVIATION 2.6 • n=6 Participants
|
28.0 kg/m^2
STANDARD_DEVIATION 7.1 • n=9 Participants
|
30.5 kg/m^2
STANDARD_DEVIATION 6.0 • n=31 Participants
|
PRIMARY outcome
Timeframe: 2 timepoints: prior to surgical prep, and 10 min after surgical prepanaerobic culture colony counts - change in anaerobic colony counts from prior to surgical prep to 10 minutes after surgical prep
Outcome measures
| Measure |
Baby Shampoo
n=8 Participants
Baby shampoo used for surgical site prep
Baby shampoo: baby shampoo will be used to prepare the surgical site prior to incision
|
Peridex (Chlorhexidine)
n=8 Participants
Peridex used for surgical site prep
Peridex: Peridex (Chlorhexidine) will be used to prepare the surgical site prior to incision
|
TechniCare (Chloroxynel)
n=6 Participants
TechniCare used for surgical site prep
TechniCare: TechniCare (chloroxynel) will be used to prepare the surgical site prior to incision
|
Betadine (Povidone- Iodine)
n=9 Participants
Betadine used for surgical site prep
Betadine: Betadine (Povidone- iodine) will be used to prepare the surgical site prior to incision
|
|---|---|---|---|---|
|
Vaginal Colony Counts (Anaerobic)
Prior to surgical scrub · # participants with positive cultures
|
6 Participants
|
8 Participants
|
6 Participants
|
8 Participants
|
|
Vaginal Colony Counts (Anaerobic)
Prior to surgical scrub · # participants with negative cultures
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Vaginal Colony Counts (Anaerobic)
Post surgical scrub · # participants with positive cultures
|
4 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
|
Vaginal Colony Counts (Anaerobic)
Post surgical scrub · # participants with negative cultures
|
4 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 2 timepoints: prior to surgical prep, and 10 min after surgical prepaerobic culture colony counts - change in aerobic colony counts from prior to surgical prep to 10 minutes after surgical prep
Outcome measures
| Measure |
Baby Shampoo
n=8 Participants
Baby shampoo used for surgical site prep
Baby shampoo: baby shampoo will be used to prepare the surgical site prior to incision
|
Peridex (Chlorhexidine)
n=8 Participants
Peridex used for surgical site prep
Peridex: Peridex (Chlorhexidine) will be used to prepare the surgical site prior to incision
|
TechniCare (Chloroxynel)
n=6 Participants
TechniCare used for surgical site prep
TechniCare: TechniCare (chloroxynel) will be used to prepare the surgical site prior to incision
|
Betadine (Povidone- Iodine)
n=9 Participants
Betadine used for surgical site prep
Betadine: Betadine (Povidone- iodine) will be used to prepare the surgical site prior to incision
|
|---|---|---|---|---|
|
Vaginal Colony Counts (Aerobic)
Prior to surgical scrub · # participants with positive cultures
|
6 Participants
|
8 Participants
|
5 Participants
|
9 Participants
|
|
Vaginal Colony Counts (Aerobic)
Prior to surgical scrub · # participants with negative cultures
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Vaginal Colony Counts (Aerobic)
Post surgical scrub · # participants with positive cultures
|
5 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Vaginal Colony Counts (Aerobic)
Post surgical scrub · # participants with negative cultures
|
3 Participants
|
4 Participants
|
6 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 2 timepoints: prior to surgical prep, and 10 min after surgical prepfungal culture colony counts - change in fungal colony counts from prior to surgical prep to 10 minutes after surgical prep
Outcome measures
| Measure |
Baby Shampoo
n=8 Participants
Baby shampoo used for surgical site prep
Baby shampoo: baby shampoo will be used to prepare the surgical site prior to incision
|
Peridex (Chlorhexidine)
n=8 Participants
Peridex used for surgical site prep
Peridex: Peridex (Chlorhexidine) will be used to prepare the surgical site prior to incision
|
TechniCare (Chloroxynel)
n=6 Participants
TechniCare used for surgical site prep
TechniCare: TechniCare (chloroxynel) will be used to prepare the surgical site prior to incision
|
Betadine (Povidone- Iodine)
n=9 Participants
Betadine used for surgical site prep
Betadine: Betadine (Povidone- iodine) will be used to prepare the surgical site prior to incision
|
|---|---|---|---|---|
|
Vaginal Colony Counts (Fungal)
Prior to surgical scrub · # participants with positive culture
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Vaginal Colony Counts (Fungal)
Prior to surgical scrub · # participants with negative culture
|
7 Participants
|
8 Participants
|
5 Participants
|
9 Participants
|
|
Vaginal Colony Counts (Fungal)
Post surgical scrub · # participants with positive culture
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Vaginal Colony Counts (Fungal)
Post surgical scrub · # participants with negative culture
|
8 Participants
|
8 Participants
|
6 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 2 timepoints: 10 min after surgical prep (prior to incision), and after incision closureChange in anaerobic culture colony counts from 10 min after surgical prep (prior to incision) to post-procedure (incision closure)
Outcome measures
| Measure |
Baby Shampoo
n=8 Participants
Baby shampoo used for surgical site prep
Baby shampoo: baby shampoo will be used to prepare the surgical site prior to incision
|
Peridex (Chlorhexidine)
n=8 Participants
Peridex used for surgical site prep
Peridex: Peridex (Chlorhexidine) will be used to prepare the surgical site prior to incision
|
TechniCare (Chloroxynel)
n=6 Participants
TechniCare used for surgical site prep
TechniCare: TechniCare (chloroxynel) will be used to prepare the surgical site prior to incision
|
Betadine (Povidone- Iodine)
n=9 Participants
Betadine used for surgical site prep
Betadine: Betadine (Povidone- iodine) will be used to prepare the surgical site prior to incision
|
|---|---|---|---|---|
|
Vaginal Colony Counts (Anaerobic)
Post surgical prep · # participants with positive cultures
|
4 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
|
Vaginal Colony Counts (Anaerobic)
Post surgical prep · # participants with negative cultures
|
4 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
|
Vaginal Colony Counts (Anaerobic)
Post procedure · # participants with positive cultures
|
3 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
|
Vaginal Colony Counts (Anaerobic)
Post procedure · # participants with negative cultures
|
5 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 2 timepoints: 10 min after surgical prep (prior to incision), and after incision closureChange in aerobic culture colony counts from 10 min after surgical prep (prior to incision) to post-procedure (incision closure)
Outcome measures
| Measure |
Baby Shampoo
n=8 Participants
Baby shampoo used for surgical site prep
Baby shampoo: baby shampoo will be used to prepare the surgical site prior to incision
|
Peridex (Chlorhexidine)
n=8 Participants
Peridex used for surgical site prep
Peridex: Peridex (Chlorhexidine) will be used to prepare the surgical site prior to incision
|
TechniCare (Chloroxynel)
n=6 Participants
TechniCare used for surgical site prep
TechniCare: TechniCare (chloroxynel) will be used to prepare the surgical site prior to incision
|
Betadine (Povidone- Iodine)
n=9 Participants
Betadine used for surgical site prep
Betadine: Betadine (Povidone- iodine) will be used to prepare the surgical site prior to incision
|
|---|---|---|---|---|
|
Vaginal Colony Counts (Aerobic)
Post surgical scrub · # participants with positive cultures
|
5 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Vaginal Colony Counts (Aerobic)
Post surgical scrub · # participants with negative cultures
|
3 Participants
|
4 Participants
|
6 Participants
|
8 Participants
|
|
Vaginal Colony Counts (Aerobic)
Post procedure · # participants with positive cultures
|
4 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Vaginal Colony Counts (Aerobic)
Post procedure · # participants with negative cultures
|
4 Participants
|
7 Participants
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 2 timepoints: 10 min after surgical prep (prior to incision), and after incision closureChange in fungal culture colony counts from 10 min after surgical prep (prior to incision) to post-procedure (incision closure)
Outcome measures
| Measure |
Baby Shampoo
n=8 Participants
Baby shampoo used for surgical site prep
Baby shampoo: baby shampoo will be used to prepare the surgical site prior to incision
|
Peridex (Chlorhexidine)
n=8 Participants
Peridex used for surgical site prep
Peridex: Peridex (Chlorhexidine) will be used to prepare the surgical site prior to incision
|
TechniCare (Chloroxynel)
n=6 Participants
TechniCare used for surgical site prep
TechniCare: TechniCare (chloroxynel) will be used to prepare the surgical site prior to incision
|
Betadine (Povidone- Iodine)
n=9 Participants
Betadine used for surgical site prep
Betadine: Betadine (Povidone- iodine) will be used to prepare the surgical site prior to incision
|
|---|---|---|---|---|
|
Vaginal Colony Counts (Fungal)
Post surgical scrub · # participants with positive cultures
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Vaginal Colony Counts (Fungal)
Post surgical scrub · # participants with negative cultures
|
8 Participants
|
8 Participants
|
6 Participants
|
9 Participants
|
|
Vaginal Colony Counts (Fungal)
Post procedure · # participants with positive cultures
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Vaginal Colony Counts (Fungal)
Post procedure · # participants with negative cultures
|
8 Participants
|
8 Participants
|
6 Participants
|
9 Participants
|
Adverse Events
Baby Shampoo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Peridex (Chlorhexidine)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TechniCare (Chloroxynel)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Betadine (Povidone- Iodine)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place