NCT07888101|Enrolling By InvitationFDA Drug
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Vaginal Clindamycin for Prevention of Vaginal Cuff Infections at Time of Hysterectomy
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Vaginal Clindamycin for Prevention of Vaginal Cuff Infections at Time of Hysterectomy
Sponsor study identifier
observational
900
1 country
1
Study Start
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This study seeks to determine ways to reduce the hospitals surgical site infection rate during hysterectomy operations.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 15, 2026
Actual (reported)October 22, 2026
Actual (reported)December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Surgical site infection
To investigate effective means of preventing gynecologic surgical site infection (SSI) following hysterectomy
30 days
Preventing vaginal cuff cellulitis
30 days
Bacterial Vaginosis
24 hours following surgery
Women who are undergoing a hysterectomy will recieve a one-time dose of Xaciato after the operation to determine if it can reduce vaginal cuff infections.
Vaginal clindamycin gel placed at the end of hysterectomy to prevent surgical site infection
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Women, 18 years and older, receiving a hysterectomy
Baylor Scott and White Medical Center- Temple
Temple, Texas, 76508, United States
Verstraelen H, Verhelst R, Roelens K, Temmerman M. Antiseptics and disinfectants for the treatment of bacterial vaginosis: a systematic review. BMC Infect Dis. 2012 Jun 28;12:148. doi: 10.1186/1471-2334-12-148.
World Health Organization. (2023). Bacterial Vaginosis [Fact Sheet]. https://www.who.int/news-room/fact-sheets/detail/bacterial-vaginosis
Qi AC, Peacock K, Luke AA, Barker A, Olsen MA, Joynt Maddox KE. Associations Between Social Risk Factors and Surgical Site Infections After Colectomy and Abdominal Hysterectomy. JAMA Netw Open. 2019 Oct 2;2(10):e1912339. doi: 10.1001/jamanetworkopen.2019.12339.
Joanna Stacey
Baylor Scott & White Medical Center - Temple
First Submitted
October 15, 2026
First Posted
October 22, 2026
Study Start
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 2027
EstimatedContact the study team to confirm eligibility.
Till SR, Morgan DM, Bazzi AA, Pearlman MD, Abdelsattar Z, Campbell DA, Uppal S. Reducing surgical site infections after hysterectomy: metronidazole plus cefazolin compared with cephalosporin alone. Am J Obstet Gynecol. 2017 Aug;217(2):187.e1-187.e11. doi: 10.1016/j.ajog.2017.03.019. Epub 2017 Mar 28.
Slomski A. Single-Dose Clindamycin Gel Highly Effective for Bacterial Vaginosis. JAMA. 2022 Jun 28;327(24):2386. doi: 10.1001/jama.2022.10377. No abstract available.
Sobel JD, Mitchell C. Bacterial vaginosis: Clinical Manifestations and diagnosis. In: UpToDate, Eckler, K (ed), Wolters Kluwer. (Accessed on January 28, 2024.)
Sabet F, Ravan S, Shahraki AD. Prophylaxis Effect of Metronidazole Vaginal Gel in Decreasing the Risk of Surgical Site Infections after Elective Hysterectomy. J Res Pharm Pract. 2023 Nov 27;12(1):9-14. doi: 10.4103/jrpp.jrpp_66_21. eCollection 2023 Jan-Mar.
Murphy PB, Bistas KG, Patel P, et al. Clindamycin. [Updated 2024 Feb 28]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK519574/
Mauck CK, Atiee GJ, McCulloh J, Reynolds L, Zack N, Friend DR. A Phase 1 pharmacokinetic study of a single-dose bioadhesive clindamycin 2% gel for bacterial vaginosis. J Antimicrob Chemother. 2022 Dec 23;78(1):257-262. doi: 10.1093/jac/dkac386.
Mauck C, Hillier SL, Gendreau J, Dart C, Chavoustie S, Sorkin-Wells V, Nicholson-Uhl C, Perez B, Jacobs M, Zack N, Friend D. Single-Dose, Bioadhesive Clindamycin 2% Gel for Bacterial Vaginosis: A Randomized Controlled Trial. Obstet Gynecol. 2022 Jun 1;139(6):1092-1102. doi: 10.1097/AOG.0000000000004805. Epub 2022 May 2.
de Lissovoy G, Fraeman K, Hutchins V, Murphy D, Song D, Vaughn BB. Surgical site infection: incidence and impact on hospital utilization and treatment costs. Am J Infect Control. 2009 Jun;37(5):387-397. doi: 10.1016/j.ajic.2008.12.010. Epub 2009 Apr 23.
Lachiewicz MP, Moulton LJ, Jaiyeoba O. Pelvic surgical site infections in gynecologic surgery. Infect Dis Obstet Gynecol. 2015;2015:614950. doi: 10.1155/2015/614950. Epub 2015 Feb 18.
Kuznicki M, Mallen A, McClung EC, Robertson SE, Todd S, Boulware D, Martin S, Quilitz R, Vargas RJ, Apte SM. Dual antibiotic prevention bundle is associated with decreased surgical site infections. Int J Gynecol Cancer. 2020 Sep;30(9):1411-1417. doi: 10.1136/ijgc-2020-001515. Epub 2020 Jul 29.
Koumans EH, Sternberg M, Bruce C, McQuillan G, Kendrick J, Sutton M, Markowitz LE. The prevalence of bacterial vaginosis in the United States, 2001-2004; associations with symptoms, sexual behaviors, and reproductive health. Sex Transm Dis. 2007 Nov;34(11):864-9. doi: 10.1097/OLQ.0b013e318074e565.
Johnson, Melissa. Clindamycin Overview. In: UpToDate, Bogorodaya M (Ed), Wolters Kluwer. (Accessed on January 28, 2024.)
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 22, 2026
Record last verified: 2026-10
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