Surgical Site InfectionNCT07888101
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
An observational study of Surgical Site Infection and Vaginal Cuff Cellulitis, run by Baylor Research Institute at 1 site in United States.
Trial summary
This study seeks to determine ways to reduce the hospitals surgical site infection rate during hysterectomy operations. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Surgical Site Infection, Vaginal Cuff Cellulitis, Bacterial Vaginosis
- What is being tested?
- Clindamycin Vaginal Gel
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women, 18 years and older, receiving a hysterectomy
Who may be able to join
- All hysterectomies (TAH, TVH, TLH, robotic), including oncology cases and those in conjunction with pelvic floor reconstruction cases (estimated 900 cases/year) performed at Baylor Scott and White Memorial Hospital over a three-year period.
- Ages 18 years old and older
Who cannot join
- Pre-existing infection, including known untreated bacterial vaginosis.
- Allergies to clindamycin
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Baylor Scott and White Medical Center- Temple
Temple, Texas, 76508
About this study
Official title: Vaginal Clindamycin for Prevention of Vaginal Cuff Infections at Time of Hysterectomy
This study seeks to determine ways to reduce the hospitals surgical site infection rate during hysterectomy operations.
Read the detailed description
This is a retrospective review and prospective observational study involving a historical comparison which aims to compare the incidence of surgical site infection (SSI) from the time frame of January 2023 to June 2024, among approximately 900 hysterectomies who received traditional IV antibiotics, to a matched number of hysterectomies starting in December 2026. This study seeks to determine if a one-time dose of Xaciato postoperatively can reduce the hospitals vaginal cuff infections, to investigate effective means of preventing gynecologic SSI and to test for the presence of bacterial vaginosis (BV) causing pathogens after administration of pre-operative vaginal prep.
- Being tested
- Clindamycin Vaginal Gel
- Keywords
- surgical site infection, hysterectomy
- Medical subject headings
- Surgical Wound Infection, Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clindamycin Vaginal GelDrug
Also called Xaciato
Vaginal clindamycin gel placed at the end of hysterectomy to prevent surgical site infection
| Study group | Role | What they receive |
|---|---|---|
| One-time dose of Xaciato | 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. Receives: Drug: Clindamycin Vaginal Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
To investigate effective means of preventing gynecologic surgical site infection (SSI) following hysterectomy
Measured: 30 days
Secondary outcomes (2)
Preventing vaginal cuff cellulitis
To investigate effective means of preventing vaginal cuff cellulitis following hysterectomy.
Measured: 30 days
Bacterial Vaginosis
To test for the presence of BV causing pathogens after administration of pre-operative vaginal prep.
Measured: 24 hours following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanna Stacey, Principal investigator, Baylor Scott & White Medical Center - Temple
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888101
- Sponsor's protocol ID
- 024-515
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22742642World 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.
PubMed 31577353Till 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.
PubMed 28363438Slomski 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.
PubMed 35762996Sobel 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.
PubMed 38213606Murphy 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.
PubMed 36418189Mauck 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.
PubMed 35675606de 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.
PubMed 19398246Lachiewicz 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.
PubMed 25788822Kuznicki 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.
PubMed 32727930Koumans 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.
PubMed 17621244Johnson, Melissa. Clindamycin Overview. In: UpToDate, Bogorodaya M (Ed), Wolters Kluwer. (Accessed on January 28, 2024.)