Using vancomycin powder to prevent infections after inguinal lymph node dissection
The Effect of Intrawound Vancomycin Powder on Surgical Site Infection in Inguinal Lymph Node Dissection
This study is testing if using vancomycin powder during surgery can help prevent infections and other complications for women having lymph node surgery for vulvar cancer.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Women and Infants Hospital of Rhode Island Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT05625373 on ClinicalTrials.gov |
What this trial studies
This pilot randomized control trial aims to evaluate the effectiveness of intrawound vancomycin powder in reducing postoperative complications in women undergoing inguinal lymph node dissection for vulvar cancer. Participants will be randomly assigned to receive either vancomycin powder or no treatment during surgery. The primary focus is on measuring the rate of postoperative complications, including surgical site infections and hospital readmissions, within 30 days post-surgery. Secondary objectives include monitoring for seroma or lymphocele development and documenting any adverse events related to the treatment.
Who should consider this trial
Good fit: Ideal candidates are women scheduled for inguinal lymph node dissection due to vulvar cancer or dysplasia.
Not a fit: Patients with known allergies to vancomycin or those with vancomycin resistance will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of surgical site infections and improve recovery outcomes for patients undergoing this procedure.
How similar studies have performed: Previous studies have shown promising results with the use of intrawound antibiotics in reducing surgical site infections, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Known allergy to vancomycin * Known resistance to vancomycin
Where this trial is running
Providence, Rhode Island
- Women and Infants Hospital — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Principal investigator: Jessica DiSilvestro, MD — Women & Infants Hospital
- Study coordinator: Jessica DiSilvestro, MD
- Email: jdisilvestro@wihri.org
- Phone: 401-274-1100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.