Efficacy of Two Vaginal Solutions in Preoperative Use

Vaginal Surgeries Clinical Trial

Official title:

Efficacy Comparison of Two Vaginal Solutions for Preoperative Use in Candidate Women for Vaginal Surgeries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03014778
• Other study ID #: 0093-15-EMC
• Status: Recruiting
• Phase: Phase 4
• First received: January 4, 2017
• Last updated: February 26, 2018
• Start date: January 1, 2017
• Est. completion date: March 2019

Study information

• Verified date: February 2018
• Source: HaEmek Medical Center, Israel
• Contact: Sharon Tzemah, MD
• Phone: 97252-6678244
• Email: sharon_tze1[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

It is well known from the literature that the use of Povidone-iodone based solution for vaginal preparation before surgery is fraught with side effects and sensitivity, and often does not provide sufficient eradication of colonies of pathogens from the operation field.

It is also known that Chlorhexidine gluconate in low concentration provides a better result and does not cause side effects more than Povidone-iodone, but the chlorhexidine is still not approved for washing the mucous membranes. This study is necessary in order to provide proof of its effectiveness and safety.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: March 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients over the age of 18

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

Exclusion Criteria:

1. A pregnant woman or post-partum.

2. A woman with known sensitivity to iodine, povidon or chlorhexidine.

3. Previous pelvic surgeries within three months from the surgery planned.

4. Patients taking antibiotics within one month from the surgery planned.

5. Immunological failure patients.

6. Patient unwilling to participate in the study.

7. Patients who require the appointment of a guardian condition

8. Women assigned to undergo a regular cystoscopy (no further action).

Related Conditions & MeSH terms

• Vaginal Surgeries

Intervention

Drug:
• The Chlorhexidine gluconate 0.05%
Washing vagina pre- operatively with Chlorhexidine gluconate 0.05%
• 10% Povidone iodine
Washing vagina pre- operatively with 10% Povidone iodine

Locations

Country	Name	City	State
Israel	Haemek Medical Center	`Afula	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (6)

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. — View 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. — View Citation

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. — View Citation

Kjølhede P, Halili S, Löfgren 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. — View Citation

Niedner R. Cytotoxicity and sensitization of povidone-iodine and other frequently used anti-infective agents. Dermatology. 1997;195 Suppl 2:89-92. Review. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changing in the number of colonies that grew at every stage		Before the washing, 10 minutes after washing, 30 minutes after washing.
Secondary	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.
Secondary	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.