ClinicalTrials.gg
Enrolling by invitationNCT07888101Updated Oct 22, 2026

Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin

An observational study in Surgical Site Infection, Vaginal Cuff Cellulitis and Bacterial Vaginosis, sponsored by Baylor Research Institute. Enrolling by invitation at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Baylor Research Institute · Observational

Updated Oct 22, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
900
Ages
18 Years and older
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Surgical Site Infection
  • Vaginal Cuff Cellulitis
  • Bacterial Vaginosis

Keywords

  • surgical site infection
  • hysterectomy
03

In context

Surgical Wound Infection

687 studies on the registry are indexed under Surgical Wound Infection; 142 are open to participants now.

This study's planned enrollment of 900 is above the median of 240 across 133 observational studies indexed under Surgical Wound Infection.

Browse Surgical Wound Infection studies →

Lead sponsor

Baylor Research Institute is the lead sponsor of 223 studies on the registry; 49 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 9 (39%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women, 18 years and older, receiving a hysterectomy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Pre-existing infection, including known untreated bacterial vaginosis.
  • Allergies to clindamycin
  • Pregnancy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
900 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Drug: Clindamycin Vaginal Gel

Interventions

  • Vaginal clindamycin gel placed at the end of hysterectomy to prevent surgical site infection

    Also known as: Xaciato

06

What researchers measure

Primary outcomes

  1. Surgical site infection

    To investigate effective means of preventing gynecologic surgical site infection (SSI) following hysterectomy

    Time frame: 30 days

Secondary outcomes

  1. Preventing vaginal cuff cellulitis

    To investigate effective means of preventing vaginal cuff cellulitis following hysterectomy.

    Time frame: 30 days

  2. Bacterial Vaginosis

    To test for the presence of BV causing pathogens after administration of pre-operative vaginal prep.

    Time frame: 24 hours following surgery

07

Study locations

1 site
  • Baylor Scott and White Medical Center- Temple
    Temple, Texas 76508, United States
08

References and documents

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 22742642 ↗
  • 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. PubMed 31577353 ↗
  • 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. PubMed 28363438 ↗
  • 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. PubMed 35762996 ↗
  • 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. PubMed 38213606 ↗
  • 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. PubMed 36418189 ↗
  • 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. PubMed 35675606 ↗
  • 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. PubMed 19398246 ↗
  • 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. PubMed 25788822 ↗
  • 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. PubMed 32727930 ↗
  • 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. PubMed 17621244 ↗
  • Johnson, Melissa. Clindamycin Overview. In: UpToDate, Bogorodaya M (Ed), Wolters Kluwer. (Accessed on January 28, 2024.)

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07888101
Responsible party
Sponsor
First posted
Oct 22, 2026
Start date
Dec 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Dec 2028 (estimated)
Last update
Oct 22, 2026

Study contacts

Joanna Stacey
principal investigator · Baylor Scott & White Medical Center - Temple

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion