NCT00550290

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
9.5 years until next milestone

Results Posted

Study results publicly available

September 18, 2018

Completed
Last Updated

October 17, 2018

Status Verified

September 1, 2018

Enrollment Period

1.5 years

First QC Date

October 25, 2007

Results QC Date

January 29, 2018

Last Update Submit

September 18, 2018

Conditions

Wound Infection

Keywords

vulvectomywound infectionwound complicationprophylactic antibioticPost-operative wound complications following vulvectomy

Outcome Measures

Primary Outcomes (1)

  • Wound Complications

    Number of participants experiencing wound complications following vulvectomy. The presence of febrile episodes, elevated WBC counts and exam findings will be used to diagnose wound complications.

    Two-week post-operative

Study Arms (2)

Cefazolin Preoperatively

ACTIVE COMPARATOR

Participants received Cefazolin 2 grams intravenously within 30 minutes prior to incision

Drug: Cefazolin Preoperatively

Cefazolin Postoperatively

EXPERIMENTAL

Participants received Cefazolin 2 gram intravenous within 30 minutes prior to incision and 1 gram Cefazolin every 8 hours for the first 24 hours post-op

Drug: Cefazolin PostOperatively

Interventions

Cefazolin PostOperativelyDRUG

Cefazolin 1 gram IV every 8 hours for a total of 3 doses. Patients in both arms will receive an initial pre-operative 2 gram dose of Cefazolin within 30 minutes prior to incision. In penicillin/cephalosporin allergic patients, the substitute of Clindamycin 900 mg IV q 8 hrs will be used.

Also known as: Ancef, Kefzol
Cefazolin Postoperatively
Cefazolin PreoperativelyDRUG

Patients in active comparator arm will receive an initial pre-operative 2 gram does of Cefazolin within 30 minutes prior to incision. In penicillin/cephalosporin allergic patients, the substitute of Clindamycin 900 mg IV will be used.

Also known as: Ancef, Kefzol
Cefazolin Preoperatively

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • Number of subjects: 160

You may not qualify if:

  • Women simultaneously undergoing treatment for other forms of cancer
  • Women under the age of 18
  • Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aultman Health Foundation

Canton, Ohio, 44710, United States

Location

MeSH Terms

Conditions

Wound Infection

Interventions

Cefazolin

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Limitations and Caveats

Small number of subjects recruited lead to unreliable data. A larger sample is needed to answer the research question.

Results Point of Contact

Title
Jane Sewell
Organization
Aultman Health Foundation
Jane.Sewell@aultman.com
330-363-6793

Study Officials

  • Michael P Hopkins, MD

    Aultman Health Foundation

    STUDY CHAIR

  • William T. Schnettler, MD

    Aultman Health Foundation

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2007

First Posted

October 29, 2007

Study Start

October 1, 2007

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

October 17, 2018

Results First Posted

September 18, 2018

Record last verified: 2018-09

Locations

US(1)