Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
70 participants
INTERVENTIONAL
2017-01-01
2019-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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The Chlorhexidine gluconate arm
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.
The Chlorhexidine gluconate 0.05%
Washing vagina pre- operatively with Chlorhexidine gluconate 0.05%
The Povidone iodine arm
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.
10% Povidone iodine
Washing vagina pre- operatively with 10% Povidone iodine
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Candidates for surgery (TOT- Trans Obturator Tape, cystoscopy, the introduction / removal of the stent the ureter, ureteroscopy), local or general anesthesia.
Exclusion Criteria
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).
18 Years
FEMALE
Yes
Sponsors
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HaEmek Medical Center, Israel
OTHER
Responsible Party
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Sharon Tzemach
Dr
Principal Investigators
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Sharon Tzemah, MD
Role: PRINCIPAL_INVESTIGATOR
Haemek MC
Locations
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Haemek Medical Center
Afula, Afula, Israel
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Vorherr H, Vorherr UF, Mehta P, Ulrich JA, Messer RH. Vaginal absorption of povidone-iodine. JAMA. 1980 Dec 12;244(23):2628-9.
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.
Other Identifiers
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0093-15-EMC
Identifier Type: -
Identifier Source: org_study_id
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