Vaginal Prep Solutions to Reduce Bacteria Colony Counts in Patients Having a Vaginal Surgery
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 2/28/2019 |
| Start Date: | April 1, 2019 |
| End Date: | June 1, 2021 |
| Contact: | Geoffrey Towers, MD |
| Email: | geoffrey.towers@wright.edu |
| Phone: | 937-208-2850 |
A Randomized Trial of Vaginal Prep Solutions to Reduce Bacteria Colony Counts in Patients Having a Vaginal Surgery
This is a randomized trial comparing the effectiveness of 4 vaginal prep solutions (betadine,
baby shampoo, TechniCare and Peridex) on reducing bacterial colony counts during surgery
preparation. Women undergoing a vaginal surgery will be enrolled into the trial prior to
surgery. Target sample size per group is 15 patients. During standard surgical prep, a
vaginal swab will be taken to assess the initial colony counts for aerobic and anaerobic
bacteria. After the initial swab, the incision point will be prepared using one of the prep 4
solutions (betadine, baby shampoo, TechniCare or Peridex). After a predefined 10 minutes, the
area will be re-swabbed to determine pre-incision colony counts. Laboratory analyses for raw
colony counts, sensitivities, identification (using MALDI-TOF) will be performed. The results
are expected to show that there will be reduced colony counts at the pre-incision point with
baby shampoo having the least reduction, followed by betadine and TechniCare, then Peridex.
Patient reported outcomes for vaginal itching and burning as well as patient report of any
treatment for vaginal infection will be collected by telephone at 2 days, 2 weeks and 1 month
post-surgery.
baby shampoo, TechniCare and Peridex) on reducing bacterial colony counts during surgery
preparation. Women undergoing a vaginal surgery will be enrolled into the trial prior to
surgery. Target sample size per group is 15 patients. During standard surgical prep, a
vaginal swab will be taken to assess the initial colony counts for aerobic and anaerobic
bacteria. After the initial swab, the incision point will be prepared using one of the prep 4
solutions (betadine, baby shampoo, TechniCare or Peridex). After a predefined 10 minutes, the
area will be re-swabbed to determine pre-incision colony counts. Laboratory analyses for raw
colony counts, sensitivities, identification (using MALDI-TOF) will be performed. The results
are expected to show that there will be reduced colony counts at the pre-incision point with
baby shampoo having the least reduction, followed by betadine and TechniCare, then Peridex.
Patient reported outcomes for vaginal itching and burning as well as patient report of any
treatment for vaginal infection will be collected by telephone at 2 days, 2 weeks and 1 month
post-surgery.
BACKGROUND AND LITERATURE REVIEW Antiseptic preparation for surgical incision sites has
greatly reduced postoperative infections. However, surgical site infections (SSI) are still
the leading cause of hospitalizations after surgery. With the application of antiseptic
preparation, a reduction in bacterial counts follows. The rate at which the bacterial counts
rise between preparation and incision may be of variation depending on the surgical
antiseptic scrub.
Betadine (Povidone- iodine), Peridex (Chlorhexidine), baby shampoo and TechniCare
(chloroxynel) are all surgical scrubs approved for the preparation of vaginal access
surgeries. While there has been controversy on the use of Chlorohexidine for vaginal
preparation surgery, due to its labeling as a cause for irritation, studies have shown that
when 2-4% Chlorhexidine is used in the vaginal area there are little to no signs of
irritation and the bacteria counts post incision are less than the bacterial counts for
povidone iodine1,2. Baby shampoo can also be used as an effective antiseptic scrub with no
irritation and no statistical difference in bacterial count reduction as compared to
povidone-iodine3. Little research has been done to look at the antiseptic power of
Chloroxynel in vaginal surgeries. However, when used as a root canal antiseptic it can reduce
bacteria counts by 99.9%4. This is illustrative of its capability to reduce bacteria on a
mucus membrane similar to the vagina.
There is literature that shows the antiseptic power of Betadine, Peridex, Baby shampoo and
TechniCare for post-incisional bacteria counts, but little is known about the pre-incisional
power of these scrubs for vaginal access surgeries.
SPECIFIC AIMS OR OBJECTIVES The aim of this study is to understand the power of vaginal
surgical scrubs before incision. This will be done by collecting bacterial samples both
before and 10 minutes after antiseptic preparation, along with follow-up data of irritation,
infection post-surgery, and infection risk factors of each patient.
SIGNIFICANCE TO PATIENT, INSTITUTION, PROFESSION, OR ALL Vaginal preparation research
provides benefitted knowledge to hospitals and physicians in the prevention of surgical site
infections (SSI). This specific project will provide insight regarding the
bacteria-eliminating power of four different surgical scrubs used on the vaginal mucous
membrane, pre-incision. There is potential for this study to determine the most effective
scrub for vaginal surgeries, as well as correlate pre-incisional bacterial counts and
likelihood of surgical site infections. The information collected from this study could
benefit future patients and hospitals alike in terms of reducing the risk of SSI's. The risks
of this study could be unidentified allergies to any of the surgical scrubs, or a loss of
patient data. These are unlikely risks due to the protocol of the study.
METHODS This study will use block randomization. There will be four arms of the study one for
each of the four surgical scrubs. There will be approximately 15 patients per arm. Patients
undergoing vaginal surgeries will be recruited from Wright State Physicians Obstetrics and
Gynecology. All procedures that require a vaginal incision will be included in the study,
these being procedures like hysterectomies and reconstruction surgery. Non-incisional
procedures like dilation and curettage will be excluded. Revision surgeries will also be
excluded to decrease any complications. Patients who consent to the study will be given a ID
and will be randomly assigned to one of the four arms. Patients will be excluded if an
allergy to any of the scrubs is listed or found. Each recruited patient will be over the age
of 18 with ability to provide consent.
Each patient will be given a standard prophylaxis 30 minutes before surgery. After
prophylaxis administration and before surgical antiseptic preparation, a one minute swab will
be taken of the vagina making sure to span the surface area of the vaginal canal with
avoidance of the cervix. The swab will then be broken off into a tube labeled with the
patient ID, date, and "pre-scrub". The patient will then undergo antiseptic preparation with
the assigned surgical prep. A standard procedure of application will be done for each of the
arms. Ten minutes after application, another swab will be taken using the same procedure as
the "pre-scrub" swab. This swab will be broken off in a tube labeled with the patient ID,
date, and "post-scrub"1. The swabs will then be transported to CompuNet for analysis of
aerobic, anaerobic bacteria and fungal colonies using Matrix Assisted
Depolarization/Ionization Time of Flight mass spectrometry (MADI-TOF).
The data of colony counts will be collected from CompuNet. BMI, age, prophylaxis,
postmenopausal information, diabetic information, smoking history, surgical duration,
complication in surgery, and length of hospital stay will all be collected from patient
records. No patient identifiers will be collected5. Patients will be followed up after
surgery approximately two days, two weeks and a month after surgery to get information on
irritation and/or surgical infection. This data will be collected either be phone call or at
post-surgical follow-up appointment at Wright State Physicians. The South Hampton Grading
Scheme for Surgical Wounds will be used to Quantify Each patients level of irritation and/or
infection. The scale is a Zero to Five score, with Zero being no irritation or infection and
Five being severe irritation or infection15.
One potential obstacle of this study could be recruitment of patients. Patients will not be
given incentive for participation and will not acquire any direct benefit from the study.
Another potential issue may arise from the size of the study; there may not be enough
subjects recruited for each arm of the study to find a detectable and significant difference
in the use of one surgical scrub over another.
Precautions will need to be taken for allergies. A recruited patient may not be aware of
personal allergies to the surgical scrubs. This would put the patient at risk of harm if
there was the potential for having an allergy to the assigned scrub. Since data will be
collected from the patient's medical records, precautions will be taken to avoid loss of
patient identifiers. All research investigators will only utilize the patients assigned
research ID. This will both protect the patient and avoid bias.
greatly reduced postoperative infections. However, surgical site infections (SSI) are still
the leading cause of hospitalizations after surgery. With the application of antiseptic
preparation, a reduction in bacterial counts follows. The rate at which the bacterial counts
rise between preparation and incision may be of variation depending on the surgical
antiseptic scrub.
Betadine (Povidone- iodine), Peridex (Chlorhexidine), baby shampoo and TechniCare
(chloroxynel) are all surgical scrubs approved for the preparation of vaginal access
surgeries. While there has been controversy on the use of Chlorohexidine for vaginal
preparation surgery, due to its labeling as a cause for irritation, studies have shown that
when 2-4% Chlorhexidine is used in the vaginal area there are little to no signs of
irritation and the bacteria counts post incision are less than the bacterial counts for
povidone iodine1,2. Baby shampoo can also be used as an effective antiseptic scrub with no
irritation and no statistical difference in bacterial count reduction as compared to
povidone-iodine3. Little research has been done to look at the antiseptic power of
Chloroxynel in vaginal surgeries. However, when used as a root canal antiseptic it can reduce
bacteria counts by 99.9%4. This is illustrative of its capability to reduce bacteria on a
mucus membrane similar to the vagina.
There is literature that shows the antiseptic power of Betadine, Peridex, Baby shampoo and
TechniCare for post-incisional bacteria counts, but little is known about the pre-incisional
power of these scrubs for vaginal access surgeries.
SPECIFIC AIMS OR OBJECTIVES The aim of this study is to understand the power of vaginal
surgical scrubs before incision. This will be done by collecting bacterial samples both
before and 10 minutes after antiseptic preparation, along with follow-up data of irritation,
infection post-surgery, and infection risk factors of each patient.
SIGNIFICANCE TO PATIENT, INSTITUTION, PROFESSION, OR ALL Vaginal preparation research
provides benefitted knowledge to hospitals and physicians in the prevention of surgical site
infections (SSI). This specific project will provide insight regarding the
bacteria-eliminating power of four different surgical scrubs used on the vaginal mucous
membrane, pre-incision. There is potential for this study to determine the most effective
scrub for vaginal surgeries, as well as correlate pre-incisional bacterial counts and
likelihood of surgical site infections. The information collected from this study could
benefit future patients and hospitals alike in terms of reducing the risk of SSI's. The risks
of this study could be unidentified allergies to any of the surgical scrubs, or a loss of
patient data. These are unlikely risks due to the protocol of the study.
METHODS This study will use block randomization. There will be four arms of the study one for
each of the four surgical scrubs. There will be approximately 15 patients per arm. Patients
undergoing vaginal surgeries will be recruited from Wright State Physicians Obstetrics and
Gynecology. All procedures that require a vaginal incision will be included in the study,
these being procedures like hysterectomies and reconstruction surgery. Non-incisional
procedures like dilation and curettage will be excluded. Revision surgeries will also be
excluded to decrease any complications. Patients who consent to the study will be given a ID
and will be randomly assigned to one of the four arms. Patients will be excluded if an
allergy to any of the scrubs is listed or found. Each recruited patient will be over the age
of 18 with ability to provide consent.
Each patient will be given a standard prophylaxis 30 minutes before surgery. After
prophylaxis administration and before surgical antiseptic preparation, a one minute swab will
be taken of the vagina making sure to span the surface area of the vaginal canal with
avoidance of the cervix. The swab will then be broken off into a tube labeled with the
patient ID, date, and "pre-scrub". The patient will then undergo antiseptic preparation with
the assigned surgical prep. A standard procedure of application will be done for each of the
arms. Ten minutes after application, another swab will be taken using the same procedure as
the "pre-scrub" swab. This swab will be broken off in a tube labeled with the patient ID,
date, and "post-scrub"1. The swabs will then be transported to CompuNet for analysis of
aerobic, anaerobic bacteria and fungal colonies using Matrix Assisted
Depolarization/Ionization Time of Flight mass spectrometry (MADI-TOF).
The data of colony counts will be collected from CompuNet. BMI, age, prophylaxis,
postmenopausal information, diabetic information, smoking history, surgical duration,
complication in surgery, and length of hospital stay will all be collected from patient
records. No patient identifiers will be collected5. Patients will be followed up after
surgery approximately two days, two weeks and a month after surgery to get information on
irritation and/or surgical infection. This data will be collected either be phone call or at
post-surgical follow-up appointment at Wright State Physicians. The South Hampton Grading
Scheme for Surgical Wounds will be used to Quantify Each patients level of irritation and/or
infection. The scale is a Zero to Five score, with Zero being no irritation or infection and
Five being severe irritation or infection15.
One potential obstacle of this study could be recruitment of patients. Patients will not be
given incentive for participation and will not acquire any direct benefit from the study.
Another potential issue may arise from the size of the study; there may not be enough
subjects recruited for each arm of the study to find a detectable and significant difference
in the use of one surgical scrub over another.
Precautions will need to be taken for allergies. A recruited patient may not be aware of
personal allergies to the surgical scrubs. This would put the patient at risk of harm if
there was the potential for having an allergy to the assigned scrub. Since data will be
collected from the patient's medical records, precautions will be taken to avoid loss of
patient identifiers. All research investigators will only utilize the patients assigned
research ID. This will both protect the patient and avoid bias.
Inclusion Criteria:
- All procedures that require a vaginal incision will be included in the study, these
being procedures like hysterectomies and reconstruction surgery.
Exclusion Criteria:
- Non-incisional procedures like dilation and curettage will be excluded.
- Revision surgeries will also be excluded to decrease any complications.
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