Prophylactic Antibiotics for Prevention of Wound Complications Following Vulvectomy
Information source: Aultman Health Foundation
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Wound Infection
Intervention: Cefazolin (or Clindamycin in patients with allergy to cephalosporins or PCN) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Aultman Health Foundation Official(s) and/or principal investigator(s):
Michael P Hopkins, MD, Study Chair, Affiliation: Aultman Health Foundation
William T. Schnettler, MD, Principal Investigator, Affiliation: Aultman Health Foundation
Overall contact:
William T Schnettler, MD, Phone: 330-363-6214, Email: wscnettler@aultman.com
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.
Clinical Details
Official title: Prophylactic Antibiotics for Prevention of Wound Complications Following Vulvectomy
Study design: Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Primary outcome: Febrile episodes, white blood cell counts, physical exam findings of vulva post-operatively
Secondary outcome: Evidence of wound infection (fever, leukocytosis, or physical exam findings of infection such as induration, edema, erythema)
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
William T Schnettler, MD, Phone: 330-363-6214, Email: wscnettler@aultman.com
Aultman Health Foundation, Canton, Ohio 44710, United States; Recruiting
William T Scnettler, MD, Phone: 330-363-6214, Email: wschnettler@aultman.com
Michael P Hopkins, MD, Phone: 330-363-6214, Email: mhopkins@aultman.com
William T Schnettler, MD, Principal Investigator
Additional Information
Starting date: October 2007
Ending date: April 2008
Last updated: January 27, 2009
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