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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.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

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
What is being tested?
Clindamycin Vaginal Gel
How many people
900 participants
Where
1 siteUnited States
Study dates
Dec 2026to Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

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

Other trials in United States

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 groups in NCT07888101
Study groupRoleWhat they receive
One-time dose of XaciatoWomen 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.

  1. Surgical site infection

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

    Measured: 30 days

Secondary outcomes (2)

  1. Preventing vaginal cuff cellulitis

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

    Measured: 30 days

  2. 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.

  1. First posted22 Oct 2026
  2. Study startDec 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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)
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 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.)

Questions about this trial

What is this clinical trial studying?

An observational study of Surgical Site Infection and Vaginal Cuff Cellulitis, run by Baylor Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical site infection (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07888101, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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