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

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. 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.

Study Overview

• Status: Suspended
• Conditions: Surgical Site Infection; Vaginal Surgery
• Intervention / Treatment: Other: Baby shampoo; Other: Peridex; Other: TechniCare; Other: Betadine

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Dayton, Ohio, United States, 45409
      • Wright State Physicians

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baby shampoo; Baby shampoo used for surgical site prep	Other: Baby shampoo; baby shampoo will be used to prepare the surgical site prior to incision
Active Comparator: Peridex (Chlorhexidine); Peridex used for surgical site prep	Other: Peridex; Peridex (Chlorhexidine) will be used to prepare the surgical site prior to incision; Other Names: Chlorhexidine
Active Comparator: TechniCare (chloroxynel); TechniCare used for surgical site prep	Other: TechniCare; TechniCare (chloroxynel) will be used to prepare the surgical site prior to incision; Other Names: chloroxynel
Active Comparator: Betadine (Povidone- iodine); Betadine used for surgical site prep	Other: Betadine; Betadine (Povidone- iodine) will be used to prepare the surgical site prior to incision; Other Names: Povidone- iodine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal Colony Counts (Anaerobic)	anaerobic culture colony counts - change in anaerobic colony counts from prior to surgical prep to 10 minutes after surgical prep	2 timepoints: prior to surgical prep, and 10 min 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	2 timepoints: prior to surgical prep, and 10 min after surgical prep

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal Colony Counts (Fungal)	fungal culture colony counts - change in fungal colony counts from prior to surgical prep to 10 minutes after surgical prep	2 timepoints: prior to surgical prep, and 10 min 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)	2 timepoints: 10 min after surgical prep (prior to incision), and after 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)	2 timepoints: 10 min after surgical prep (prior to incision), and after 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)	2 timepoints: 10 min after surgical prep (prior to incision), and after incision closure

Collaborators and Investigators

• Sponsor: Wright State University
• Investigators: Principal Investigator: Geoffrey Towers, MD, Wright State Univeristy

Publications and helpful links

General Publications

• Culver DH, Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG, Banerjee SN, Edwards JR, Tolson JS, Henderson TS, et al. Surgical wound infection rates by wound class, operative procedure, and patient risk index. National Nosocomial Infections Surveillance System. Am J Med. 1991 Sep 16;91(3B):152S-157S. doi: 10.1016/0002-9343(91)90361-z.
• 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.
• Kjolhede P, Halili S, Lofgren M. Vaginal cleansing and postoperative infectious morbidity in vaginal hysterectomy. A register study from the Swedish National Register for Gynecological Surgery. Acta Obstet Gynecol Scand. 2011 Jan;90(1):63-71. doi: 10.1111/j.1600-0412.2010.01023.x. Epub 2010 Nov 26.
• 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.
• 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.
• 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.
• Bailey IS, Karran SE, Toyn K, Brough P, Ranaboldo C, Karran SJ. Community surveillance of complications after hernia surgery. BMJ. 1992 Feb 22;304(6825):469-71. doi: 10.1136/bmj.304.6825.469. Erratum In: BMJ 1992 Mar 21;304(6829):739.
• 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.
• 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.
• 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.
• Vorherr H, Ulrich JA, Messer RH, Hurwitz EB. Antimicrobial effect of chlorhexidine on bacteria of groin, perineum and vagina. J Reprod Med. 1980 Apr;24(4):153-7.
• Aly R, Maibach HI. Comparative antibacterial efficacy of a 2-minute surgical scrub with chlorhexidine gluconate, povidone-iodine, and chloroxylenol sponge-brushes. Am J Infect Control. 1988 Aug;16(4):173-7. doi: 10.1016/0196-6553(88)90029-6.
• Faro C, Faro S. Postoperative pelvic infections. Infect Dis Clin North Am. 2008 Dec;22(4):653-663. doi: 10.1016/j.idc.2008.05.005.
• Steiner HL, Strand EA. Surgical-site infection in gynecologic surgery: pathophysiology and prevention. Am J Obstet Gynecol. 2017 Aug;217(2):121-128. doi: 10.1016/j.ajog.2017.02.014. Epub 2017 Feb 14.

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2019
• Primary Completion (Actual): September 30, 2023
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: January 18, 2019
• First Submitted That Met QC Criteria: February 22, 2019
• First Posted (Actual): February 26, 2019

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: baby shampoo; surgical prep; vaginal prep
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wound Infection; Surgical Wound Infection; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Plasma Substitutes; Blood Substitutes; Chlorhexidine; Povidone-Iodine; Povidone
• Other Study ID Numbers: 06612

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No