Trial Outcomes & Findings for Prophylactic Antibiotics for Prevention of Wound Complications Following Vulvectomy (NCT NCT00550290)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

18 participants

Primary outcome timeframe

Two-week post-operative

Results posted on

2018-10-17

Participant Flow

From July, 2007 through December, 2008, all patients undergoing surgical treatment for vulvar cancer at a single tertiary care center were offered enrollment and randomization.

Participant milestones

Participant milestones
Measure	24 Hour Post-operative Course of Cefazolin Patients undergoing surgical treatment for vulvar cancer randomized to an extended 24 hour post-operative course of Cefazolin	Pre-operative Single Dose of Cefazolin. Patients randomized to the standard pre-operative single dosing regimen of Cefazolin.
Overall Study STARTED	10	8
Overall Study COMPLETED	10	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prophylactic Antibiotics for Prevention of Wound Complications Following Vulvectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	24 Hour Post-operative Course of Cefazolin n=10 Participants Patients undergoing surgical treatment for vulvar cancer randomized to an extended 24 hour post-operative course of Cefazolin	Pre-operative Single Dose of Cefazolin. n=8 Participants Patients randomized to the standard pre-operative single dosing regimen of Cefazolin.	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=39 Participants	8 Participants n=41 Participants	18 Participants n=35 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Sex: Female, Male Female	10 Participants n=39 Participants	8 Participants n=41 Participants	18 Participants n=35 Participants
Sex: Female, Male Male	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants

PRIMARY outcome

Timeframe: Two-week post-operative

Population: All participants who received their assigned dose of each intervention and completed all study visits were included in the efficacy analysis.

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.

Outcome measures

Outcome measures
Measure	24 Hour Post-operative Course of Cefazolin n=10 Participants Patients undergoing surgical treatment for vulvar cancer randomized to an extended 24 hour post-operative course of Cefazolin	Pre-operative Single Dose of Cefazolin. n=8 Participants Patients randomized to the standard pre-operative single dosing regimen of Cefazolin.
Wound Complications	3 Participants	2 Participants

Adverse Events

24 Hour Post-operative Course of Cefazolin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pre-operative Single Dose of Cefazolin.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jane Sewell

Aultman Health Foundation

Phone: 330-363-6793

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place