Postoperative ComplicationsPhase 2/3NCT05625373
The Effect of Intrawound Vancomycin Powder on Surgical Site Infection in Inguinal Lymph Node Dissection
A Phase 2/3 study testing Vancomycin in people with Postoperative Complications, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial summary
The study will be a pilot randomized control trial with a 1:1 patient randomization of vancomycin powder placement at the time of surgery (compared to no vancomycin placement) with the goal of reducing postoperative complications in patients undergoing an inguinal lymph node dissection for vulvar cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Vancomycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2022to 30 Aug 2024
- Phase
- Phase 2/3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women who are undergoing inguinal lymph node dissection for vulvar dysplasia
- Women with a prior lymph node dissection >30 days before
- Women undergoing either a sentinel lymph node biopsy or full lymphadenectomy in a unilateral or bilateral groin dissection
Who cannot join
- Known allergy to vancomycin
- Known resistance to vancomycin
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, 1 recruiting
- Recruiting
Women and Infants Hospital
Providence, Rhode Island, 02905
Jessica DiSilvestro, MD, 401-274-1100, jdisilvestro@wihri.org
Elizabeth Lokich, MD, 401-274-1100, elokich@wihri.org
About this study
The study will be a pilot randomized control trial with a 1:1 patient randomization of vancomycin powder placement at the time of surgery (compared to no vancomycin placement) with the goal of reducing postoperative complications in patients undergoing an inguinal lymph node dissection for vulvar cancer. The primary objective is to measure the composite rate of postoperative complications within 30 days of inguinal lymph node dissection in patients with vulvar cancer.
Read the detailed description
The aim of the study is to investigate the impact of intrawound vancomycin powder on surgical site infections. The primary objective is to measure the composite rate of postoperative complications, including inguinal wound infection (superficial and deep surgical site infection), inguinal incision separation, and hospital readmission within 30 days of inguinal lymph node dissection in women with vulvar cancer.
Secondary objectives include assessing the rate of seroma or lymphocele development within 30 days of surgery. Adverse events including allergic reactions (systemic or local hypersensitivity reactions) and antibiotic resistant infections (based on wound cultures) will be described.
The study will be a pilot randomized control trial with a 1:1 patient randomization of vancomycin powder placement at the time of surgery. The investigators will identify women who are planning to undergo inguinal lymph node dissection for vulvar cancer and after consented will be randomized to either receive intrawound vancomycin powder in the operating room or to not receive intrawound vancomycin powder. Women randomized to receive vancomycin powder will receive 1g into each of the irrigated inguinal surgical beds (maximum of 2g dose per patient).
Patients will be followed post operatively at their standard postoperative visits typically at 1-3 week intervals until adequate healing of their incisions. An electronic questionnaire will be administered to all patients at the postoperative visits between 3-6 weeks to assess recovery and complications. Outcomes will be collected until six weeks postoperatively. The study will be conducted at a single institution
- Conditions
- Postoperative Complications
- Being tested
- Vancomycin
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
The powder will be placed within the surgical wound prior to skin closure.
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin powder | Experimental | Women randomized to receive vancomycin powder will receive 1g into each of the irrigated inguinal surgical beds (maximum of 2g dose per patient). After dissection and irrigation of the surgical bed, the operating room staff will open the medication vial and sterilely dispense the medication into a sterile container. The surgeon will place the medication powder into the irrigated and hemostatic surgical bed. The procedure will be repeated on the opposite side after dissection. Receives: Drug: Vancomycin |
| No vancomycin powder | No intervention | Patient randomized to the no vancomycin arm will not receive the intraoperative antibiotic. Their surgery will follow standard protocol. No placebo will be utilized. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite rate of postoperative complications
Rate of composite postoperative complications including inguinal wound infection (superficial and deep surgical site infection), inguinal incision separation, and hospital readmission within 30 days
Measured: Within 30 days after surgery
Secondary outcomes (2)
Antibiotic resistant infections
Rate of antibiotic resistant infections based on wound cultures of a postoperative infection
Measured: Within 30 days after surgery
Allergic reactions
Rate of systemic or local hypersensitivity reactions of the inguinal incision
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start25 Oct 2022
- Primary completion25 Apr 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized 1:1 unblinded to either receive vancomycin powder in the operating room or no vancomycin powder (no placebo utilized).
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica DiSilvestro, Women and Infants Hospital of Rhode Island
- Investigators
- Jessica DiSilvestro, MD, Principal investigator, Women & Infants Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625373
- Sponsor's protocol ID
- 1895541
- Status last verified
- Dec 2023
- First submitted
- 14 Nov 2022
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
DiSilvestro JB, Zitek E, Robison K, Ebott J, Jansen C, Eurich K, Mathews C, DiSilvestro P, Oliver M, Stuckey A, Miller K, Lokich E. The effect of intrawound vancomycin powder on surgical site infection in inguinal lymph node dissection: a randomized controlled trial pilot study. Gynecol Oncol Rep. 2025 May 9;59:101765. doi: 10.1016/j.gore.2025.101765. eCollection 2025 Jun.
PubMed 40487852
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intrawound Vancomycin Powder on Surgical Site Infection in Inguinal Lymph Node Dissection
- ClinicalTrials.gov ID
- NCT05625373
- Acronym / sponsor ID
- 1895541
- Conditions
- Postoperative Complications
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 25 Apr 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 22 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will be a pilot randomized control trial with a 1:1 patient randomization of vancomycin powder placement at the time of surgery (compared to no vancomycin placement) with the goal of reducing postoperative complications in patients undergoing an inguinal lymph node dissection for vulvar cancer. The primary objective is to measure the composite rate of postoperative complications within 30 days of inguinal lymph node dissection in patients with vulvar cancer.
Detailed description
The aim of the study is to investigate the impact of intrawound vancomycin powder on surgical site infections. The primary objective is to measure the composite rate of postoperative complications, including inguinal wound infection (superficial and deep surgical site infection), inguinal incision separation, and hospital readmission within 30 days of inguinal lymph node dissection in women with vulvar cancer.
Secondary objectives include assessing the rate of seroma or lymphocele development within 30 days of surgery. Adverse events including allergic reactions (systemic or local hypersensitivity reactions) and antibiotic resistant infections (based on wound cultures) will be described.
The study will be a pilot randomized control trial with a 1:1 patient randomization of vancomycin powder placement at the time of surgery. The investigators will identify women who are planning to undergo inguinal lymph node dissection for vulvar cancer and after consented will be randomized to either receive intrawound vancomycin powder in the operating room or to not receive intrawound vancomycin powder. Women randomized to receive vancomycin powder will receive 1g into each of the irrigated inguinal surgical beds (maximum of 2g dose per patient).
Patients will be followed post operatively at their standard postoperative visits typically at 1-3 week intervals until adequate healing of their incisions. An electronic questionnaire will be administered to all patients at the postoperative visits between 3-6 weeks to assess recovery and complications. Outcomes will be collected until six weeks postoperatively. The study will be conducted at a single institution
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized 1:1 unblinded to either receive vancomycin powder in the operating room or no vancomycin powder (no placebo utilized).
| Arm | Type | Receives |
|---|---|---|
| Vancomycin powder | Experimental | Drug: VancomycinWomen randomized to receive vancomycin powder will receive 1g into each of the irrigated inguinal surgical beds (maximum of 2g dose per patient). After dissection and irrigation of the surgical bed, the operating room staff will open the medication vial and sterilely dispense the medication into a sterile container. The surgeon will place the medication powder into the irrigated and hemostatic surgical bed. The procedure will be repeated on the opposite side after dissection. |
| No vancomycin powder | No intervention | –Patient randomized to the no vancomycin arm will not receive the intraoperative antibiotic. Their surgery will follow standard protocol. No placebo will be utilized. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women who are undergoing inguinal lymph node dissection for vulvar dysplasia
- Women with a prior lymph node dissection >30 days before
- Women undergoing either a sentinel lymph node biopsy or full lymphadenectomy in a unilateral or bilateral groin dissection
Key exclusion criteria (2 listed)
- Known allergy to vancomycin
- Known resistance to vancomycin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VancomycinThe powder will be placed within the surgical wound prior to skin closure. | Drug | Vancomycin powder |
Primary outcome
Composite rate of postoperative complications
Time frame: Within 30 days after surgery
Rate of composite postoperative complications including inguinal wound infection (superficial and deep surgical site infection), inguinal incision separation, and hospital readmission within 30 days
2 secondary outcomes
Antibiotic resistant infections
Time frame: Within 30 days after surgery
Allergic reactions
Time frame: Within 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Derived from this study: PubMed 40487852DiSilvestro JB, Zitek E, Robison K, Ebott J, Jansen C, Eurich K, Mathews C, DiSilvestro P, Oliver M, Stuckey A, Miller K, Lokich E. The effect of intrawound vancomycin powder on surgical site infection in inguinal lymph node dissection: a randomized controlled trial pilot study. Gynecol Oncol Rep. 2025 May 9;59:101765. doi: 10.1016/j.gore.2025.101765. eCollection 2025 Jun.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica DiSilvestro, MD principal investigator
Women & Infants Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vancomycin in people with Postoperative Complications, run by Women and Infants Hospital of Rhode Island 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 5 Dec 2023. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Jessica DiSilvestro, MD (401-274-1100, jdisilvestro@wihri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite rate of postoperative complications (time frame: Within 30 days after surgery). 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 NCT05625373, which also lists 1 linked publication.
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 5 Dec 2023.