drugset / Trial / NCT03014778
Efficacy of Two Vaginal Solutions in Preoperative Use
RandomizedParallel-groupSingle-blindOther
Summary
This study is necessary in order to provide proof the effectiveness of Chlorhexidine gluconate and its safety.
Timeline
- Start
- 2017-01-01
- Primary completion
- 2018-12-31
- Completion
- 2019-03
Publications
- Background 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.
- 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.
- 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.
- Background Vorherr H, Vorherr UF, Mehta P, Ulrich JA, Messer RH. Vaginal absorption of povidone-iodine. JAMA. 1980 Dec 12;244(23):2628-9.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Chlorhexidine gluconate | Other / unclassified | 0.05 % | Other |
| Comparator | Povidone-Iodine | Other / unclassified | 10 % | Other |
Indications
No indication recorded.