Phase 4
N=18
Prophylactic Antibiotics for Prevention of Wound Complications Following Vulvectomy
Wound Infection
Bottom Line
View on ClinicalTrials.gov: NCT00550290 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: Wound Complications — 3; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Cefazolin PostOperatively (Drug); Cefazolin Preoperatively (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Aultman Health Foundation
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wound Complications |
3; 2 | — |
Summary
This randomized prospective study will specifically investigate the efficacy of a 24 hour post-operative course of broad-spectrum prophylactic antibiotics - namely Cefazolin - in preventing wound infection and wound breakdown following vulvectomy.
Eligibility Criteria
Inclusion Criteria
- All female patients 18 years of age or older undergoing surgery for vulvar carcinoma (this includes female patients undergoing any form of vulvectomy - radical, vulvectomy without groin node dissection, and partial vulvectomy)
- Disease State will not affect inclusion in the study. Women with previous surgery for vulvar carcinoma will be included as will those undergoing initial operation.
- Number of subjects: 160
Exclusion Criteria
- Women simultaneously undergoing treatment for other forms of cancer
- Women under the age of 18
- Pregnant patients
Data sourced from ClinicalTrials.gov (NCT00550290). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.