Wound Infection
Conditions
Keywords
vulvectomy, wound infection, wound complication, prophylactic antibiotic, Post-operative wound complications following vulvectomy
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.
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.
Interventions
DRUGCefazolin PostOperatively
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.
DRUGCefazolin Preoperatively
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.
Sponsors
Aultman Health Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Complications | Two-week post-operative | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| Pre-operative Single Dose of Cefazolin. Patients randomized to the standard pre-operative single dosing regimen of Cefazolin. | 8 |
| Total | 18 |
Baseline characteristics
| Characteristic | 24 Hour Post-operative Course of Cefazolin | Pre-operative Single Dose of Cefazolin. | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 8 Participants | 18 Participants |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 18 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 8 |
| other Total, other adverse events | 0 / 10 | 0 / 8 |
| serious Total, serious adverse events | 0 / 10 | 0 / 8 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 24 Hour Post-operative Course of Cefazolin | Wound Complications | 3 Participants |
| Pre-operative Single Dose of Cefazolin. | Wound Complications | 2 Participants |