Efficacy of Two Vaginal Solutions in Preoperative Use

NCT03014778 | Unknown Phase 4

• 1 other identifier: 0093-15-EMC
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study is necessary in order to provide proof the effectiveness of Chlorhexidine gluconate and its safety.

Conditions

Vaginal Surgeries

Outcome Measures

Primary Outcomes (1)

• Changing in the number of colonies that grew at every stage

  Before the washing, 10 minutes after washing, 30 minutes after washing.

Secondary Outcomes (2)

• Signs of local irritation mucosa after each bathing preparations by looking at the mucosa, at the end of the clinical assessment.

  30 minutes after washing.

• The appearance of signs of systemic allergic reactions after each bathing by looking at the mucosa, at the end of the clinical assessment.

  Before the washing, 10 minutes after washing, 30 minutes after washing.

Study Arms (2)

The Chlorhexidine gluconate arm

EXPERIMENTAL

35 women undergoing surgery will be vaginally pre-op washed by 0.05% chlorhexidine gluconate, 50 cc for 1 minute. 3 samples will be taken for culture: before, 10 minutes and 30 minutes after the wash.

Drug: The Chlorhexidine gluconate 0.05%

The Povidone iodine arm

ACTIVE COMPARATOR

35 women undergoing surgery will be vaginally pre-op washed by 10% Povidone iodine, 50 cc for 1 minute. 3 samples will be taken for culture: before, 10 minutes and 30 minutes after the wash.

Drug: 10% Povidone iodine

Interventions

The Chlorhexidine gluconate 0.05% DRUG

Washing vagina pre- operatively with Chlorhexidine gluconate 0.05%

Also known as: Sterets unisept

The Chlorhexidine gluconate arm

10% Povidone iodine DRUG

Washing vagina pre- operatively with 10% Povidone iodine

The Povidone iodine arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over the age of 18
• Candidates for surgery (TOT- Trans Obturator Tape, cystoscopy, the introduction / removal of the stent the ureter, ureteroscopy), local or general anesthesia.

You may not qualify if:

• A pregnant woman or post-partum.
• A woman with known sensitivity to iodine, povidon or chlorhexidine.
• Previous pelvic surgeries within three months from the surgery planned.
• Patients taking antibiotics within one month from the surgery planned.
• Immunological failure patients.
• Patient unwilling to participate in the study.
• Patients who require the appointment of a guardian condition
• Women assigned to undergo a regular cystoscopy (no further action).

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Haemek Medical Center

Afula, Afula, 1834111, Israel

RECRUITING

Related Publications (6)

• Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988.

  PMID: 20054046 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

• Niedner R. Cytotoxicity and sensitization of povidone-iodine and other frequently used anti-infective agents. Dermatology. 1997;195 Suppl 2:89-92. doi: 10.1159/000246038.

  PMID: 9403263 BACKGROUND

• Vorherr H, Vorherr UF, Mehta P, Ulrich JA, Messer RH. Vaginal absorption of povidone-iodine. JAMA. 1980 Dec 12;244(23):2628-9.

  PMID: 7431610 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

• 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

MeSH Terms

Interventions

Povidone-Iodine

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

Study Officials

• Sharon Tzemah, MD

  Haemek MC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon Tzemah, MD

CONTACT

97252-6678244; sharon_tze1@clalit.org.il

Michael Gross, MD

CONTACT

97254-6676778; michael_gr1@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 9, 2017
• Study Start: January 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: March 1, 2019
• Last Updated: February 28, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)