Prophylactic Antibiotics for Prevention of Wound Complications Following Vulvectomy

Infectious morbidity in gynecologic oncology has not been thoroughly investigated to date.
Included in the literature are several studies that highlight substantial numbers of
post-surgical infectious complications. Specifically among patients undergoing radical
vulvectomy, the incidence of post-operative wound complication is as high as 58%. Surgery is
the treatment of choice for vulvar cancer, but few studies establish protocols or management
strategies to prevent the complications of post-operative wound infection and breakdown. This
proposed randomized prospective study would 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. This same regimen has
been described by a leader in the field of gynecology in his text - TeLinde's Operative
Gynecology. This study will utilize two arms - one as the treatment arm utilizing 24 hours of
prophylactic antibiotics and the other as control.

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