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

NCT03854370 | Terminated Results

• 1 other identifier: 06612
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection; Vaginal Surgery

Keywords

surgical prep; vaginal prep; baby shampoo

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Vaginal Colony Counts (Fungal)

  2 timepoints: prior to surgical prep, and 10 min after surgical prep

• Vaginal Colony Counts (Anaerobic)

  2 timepoints: 10 min after surgical prep (prior to incision), and after incision closure

• Vaginal Colony Counts (Aerobic)

  2 timepoints: 10 min after surgical prep (prior to incision), and after incision closure

• Vaginal Colony Counts (Fungal)

  2 timepoints: 10 min after surgical prep (prior to incision), and after incision closure

Study Arms (4)

Baby shampoo

EXPERIMENTAL

Baby shampoo used for surgical site prep

Other: Baby shampoo

Peridex (Chlorhexidine)

ACTIVE COMPARATOR

Peridex used for surgical site prep

Other: Peridex

TechniCare (chloroxynel)

ACTIVE COMPARATOR

TechniCare used for surgical site prep

Other: TechniCare

Betadine (Povidone- iodine)

ACTIVE COMPARATOR

Betadine used for surgical site prep

Other: Betadine

Interventions

Baby shampoo OTHER

baby shampoo will be used to prepare the surgical site prior to incision

Baby shampoo

Betadine OTHER

Betadine (Povidone- iodine) will be used to prepare the surgical site prior to incision

Also known as: Povidone- iodine

Betadine (Povidone- iodine)

Peridex OTHER

Peridex (Chlorhexidine) will be used to prepare the surgical site prior to incision

Also known as: Chlorhexidine

Peridex (Chlorhexidine)

TechniCare OTHER

TechniCare (chloroxynel) will be used to prepare the surgical site prior to incision

Also known as: chloroxynel

TechniCare (chloroxynel)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All procedures that require a vaginal incision will be included in the study, these being procedures like hysterectomies and reconstruction surgery.

You may not qualify if:

• Non-incisional procedures like dilation and curettage will be excluded.
• Revision surgeries will also be excluded to decrease any complications.

Sponsors & Collaborators

• Wright State University: lead

Study Sites (1)

Wright State Physicians

Dayton, Ohio, 45409, United States

Location

Related Publications (14)

• 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.

  PMID: 15695981 BACKGROUND

• 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.

  PMID: 27234011 BACKGROUND

• 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.

  PMID: 28072611 BACKGROUND

• 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.

  PMID: 17980335 BACKGROUND

• 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.

  PMID: 11699743 BACKGROUND

• 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.

  PMID: 23963423 BACKGROUND

• 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.

  PMID: 16890564 BACKGROUND

• 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.

  PMID: 7373599 BACKGROUND

• 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.

  PMID: 3189943 BACKGROUND

• 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.

  PMID: 1656747 BACKGROUND

• 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.

  PMID: 18954757 BACKGROUND

• 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.

  PMID: 21275917 BACKGROUND

• 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.

  PMID: 28209490 BACKGROUND

• 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.

  PMID: 1547415 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Povidone-Iodine; chlorhexidine gluconate; Chlorhexidine

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Biguanides; Guanidines; Amidines

Limitations and Caveats

This study does have significant limitations which make application to all vaginal surgeries difficult. The small sample size increases the risk of bias so these results should be interpreted with caution. We experienced several challenges that impacted our enrollment of patients into the study including the cancellation of elective surgeries during the COVID-19 pandemic, and several periods when PCMX was not available.

Results Point of Contact

• Title: Dr. Geoffrey Towers
• Organization: Wright State University

geoffrey.towers@wright.edu

937-208-2850

Study Officials

• Geoffrey Towers, MD

  Wright State Univeristy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and laboratory staff will not know which group cases have been assigned
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized to 1 of 4 surgical prep agents

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: February 26, 2019
• Study Start: June 21, 2019
• Primary Completion: September 30, 2023
• Study Completion: January 1, 2024
• Last Updated: October 30, 2024
• Results First Posted: April 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1 year after completion of the study
• Access Criteria: Considered on a case by case basis

Locations

US (1)