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Vaginal Prep Solutions to Reduce Bacteria Colony Counts in Patients Having a Vaginal Surgery

Primary Purpose

Surgical Site Infection, Vaginal Surgery

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Baby shampoo
Betadine
Peridex
TechniCare
Sponsored by
Wright State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection focused on measuring surgical prep, vaginal prep, baby shampoo

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Wright State Physicians

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

Baby shampoo

Peridex (Chlorhexidine)

TechniCare (chloroxynel)

Betadine (Povidone- iodine)

Arm Description

Baby shampoo used for surgical site prep

Peridex used for surgical site prep

TechniCare used for surgical site prep

Betadine used for surgical site prep

Outcomes

Primary Outcome Measures

Vaginal colony counts (anaerobic)
anaerobic culture colony counts - change in anaerobic colony counts from prior to surgical prep to 10 minutes after surgical prep
Vaginal colony counts (aerobic)
aerobic culture colony counts - change in aerobic colony counts from prior to surgical prep to 10 minutes after surgical prep

Secondary Outcome Measures

Vaginal colony counts (fungal)
fungal culture colony counts - change in fungal colony counts from prior to surgical prep to 10 minutes after surgical prep
Vaginal colony counts (anaerobic)
Change in anaerobic culture colony counts from 10 min after surgical prep (prior to incision) to post-procedure (incision closure)
Vaginal colony counts (aerobic)
Change in aerobic culture colony counts from 10 min after surgical prep (prior to incision) to post-procedure (incision closure)
Vaginal colony counts (fungal)
Change in fungal culture colony counts from 10 min after surgical prep (prior to incision) to post-procedure (incision closure)

Full Information

First Posted
January 18, 2019
Last Updated
October 9, 2023
Sponsor
Wright State University
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1. Study Identification

Unique Protocol Identification Number
NCT03854370
Brief Title
Vaginal Prep Solutions to Reduce Bacteria Colony Counts in Patients Having a Vaginal Surgery
Official Title
A Randomized Trial of Vaginal Prep Solutions to Reduce Bacteria Colony Counts in Patients Having a Vaginal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Suspended
Why Stopped
COVID impact on recruitment; challenges with enrollment
Study Start Date
June 21, 2019 (Actual)
Primary Completion Date
September 30, 2023 (Actual)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wright State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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. A third swab will be collected after incision closure. 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.
Detailed Description
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 and after incision closure, 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 the post-procedure bacterial counts with 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. After incision closure, a third swab will be taken and will be labeled 'post-procedure'. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection, Vaginal Surgery
Keywords
surgical prep, vaginal prep, baby shampoo

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized to 1 of 4 surgical prep agents
Masking
ParticipantOutcomes Assessor
Masking Description
Patients and laboratory staff will not know which group cases have been assigned
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baby shampoo
Arm Type
Experimental
Arm Description
Baby shampoo used for surgical site prep
Arm Title
Peridex (Chlorhexidine)
Arm Type
Active Comparator
Arm Description
Peridex used for surgical site prep
Arm Title
TechniCare (chloroxynel)
Arm Type
Active Comparator
Arm Description
TechniCare used for surgical site prep
Arm Title
Betadine (Povidone- iodine)
Arm Type
Active Comparator
Arm Description
Betadine used for surgical site prep
Intervention Type
Other
Intervention Name(s)
Baby shampoo
Intervention Description
baby shampoo will be used to prepare the surgical site prior to incision
Intervention Type
Other
Intervention Name(s)
Betadine
Other Intervention Name(s)
Povidone- iodine
Intervention Description
Betadine (Povidone- iodine) will be used to prepare the surgical site prior to incision
Intervention Type
Other
Intervention Name(s)
Peridex
Other Intervention Name(s)
Chlorhexidine
Intervention Description
Peridex (Chlorhexidine) will be used to prepare the surgical site prior to incision
Intervention Type
Other
Intervention Name(s)
TechniCare
Other Intervention Name(s)
chloroxynel
Intervention Description
TechniCare (chloroxynel) will be used to prepare the surgical site prior to incision
Primary Outcome Measure Information:
Title
Vaginal colony counts (anaerobic)
Description
anaerobic culture colony counts - change in anaerobic colony counts from prior to surgical prep to 10 minutes after surgical prep
Time Frame
2 timepoints: prior to surgical prep, and 10 min after surgical prep
Title
Vaginal colony counts (aerobic)
Description
aerobic culture colony counts - change in aerobic colony counts from prior to surgical prep to 10 minutes after surgical prep
Time Frame
2 timepoints: prior to surgical prep, and 10 min after surgical prep
Secondary Outcome Measure Information:
Title
Vaginal colony counts (fungal)
Description
fungal culture colony counts - change in fungal colony counts from prior to surgical prep to 10 minutes after surgical prep
Time Frame
2 timepoints: prior to surgical prep, and 10 min after surgical prep
Title
Vaginal colony counts (anaerobic)
Description
Change in anaerobic culture colony counts from 10 min after surgical prep (prior to incision) to post-procedure (incision closure)
Time Frame
2 timepoints: 10 min after surgical prep (prior to incision), and after incision closure
Title
Vaginal colony counts (aerobic)
Description
Change in aerobic culture colony counts from 10 min after surgical prep (prior to incision) to post-procedure (incision closure)
Time Frame
2 timepoints: 10 min after surgical prep (prior to incision), and after incision closure
Title
Vaginal colony counts (fungal)
Description
Change in fungal culture colony counts from 10 min after surgical prep (prior to incision) to post-procedure (incision closure)
Time Frame
2 timepoints: 10 min after surgical prep (prior to incision), and after incision closure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geoffrey Towers, MD
Organizational Affiliation
Wright State Univeristy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wright State Physicians
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared on a case by case basis
IPD Sharing Time Frame
1 year after completion of the study
IPD Sharing Access Criteria
Considered on a case by case basis
Citations:
PubMed Identifier
15695981
Citation
Culligan PJ, Kubik K, Murphy M, Blackwell L, Snyder J. A randomized trial that compared povidone iodine and chlorhexidine as antiseptics for vaginal hysterectomy. Am J Obstet Gynecol. 2005 Feb;192(2):422-5. doi: 10.1016/j.ajog.2004.08.010.
Results Reference
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PubMed Identifier
27234011
Citation
Al-Niaimi A, Rice LW, Shitanshu U, Garvens B, Fitzgerald M, Zerbel S, Safdar N. Safety and tolerability of chlorhexidine gluconate (2%) as a vaginal operative preparation in patients undergoing gynecologic surgery. Am J Infect Control. 2016 Sep 1;44(9):996-8. doi: 10.1016/j.ajic.2016.02.036. Epub 2016 May 24.
Results Reference
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PubMed Identifier
28072611
Citation
Garcia GA, Nguyen CV, Yonkers MA, Tao JP. Baby Shampoo Versus Povidone-Iodine or Isopropyl Alcohol in Reducing Eyelid Skin Bacterial Load. Ophthalmic Plast Reconstr Surg. 2018 Jan/Feb;34(1):43-48. doi: 10.1097/IOP.0000000000000850.
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Citation
Lewis LA, Lathi RB, Crochet P, Nezhat C. Preoperative vaginal preparation with baby shampoo compared with povidone-iodine before gynecologic procedures. J Minim Invasive Gynecol. 2007 Nov-Dec;14(6):736-9. doi: 10.1016/j.jmig.2007.05.010.
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PubMed Identifier
11699743
Citation
Schafer E, Bossmann K. Antimicrobial efficacy of chloroxylenol and chlorhexidine in the treatment of infected root canals. Am J Dent. 2001 Aug;14(4):233-7.
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PubMed Identifier
23963423
Citation
American College of Obstetricians and Gynecologists Women's Health Care Physicians; Committee on Gynecologic Practice. Committee Opinion No. 571: Solutions for surgical preparation of the vagina. Obstet Gynecol. 2013 Sep;122(3):718-20. doi: 10.1097/01.AOG.0000433982.36184.95.
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Van Wicklin SA. Preoperative vaginal preps with chlorhexidine gluconate solution. Am J Obstet Gynecol. 2006 Aug;195(2):624; author reply 625. doi: 10.1016/j.ajog.2005.11.002. Epub 2006 Apr 21. No abstract available.
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Vaginal Prep Solutions to Reduce Bacteria Colony Counts in Patients Having a Vaginal Surgery

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