A Phase 4 interventional study of Cefazolin PostOperatively and Cefazolin Preoperatively in Wound Infection, sponsored by Aultman Health Foundation. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-17.
Sponsored by Aultman Health Foundation · Phase 4, Interventional, and Prevention
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.
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.
382 studies on the registry are indexed under Wound Infection; 40 are open to participants now.
This study's enrollment of 18 is below the median of 150 across 296 interventional studies indexed under Wound Infection.
Browse Wound Infection studies →Aultman Health Foundation is the lead sponsor of 13 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received Cefazolin 2 grams intravenously within 30 minutes prior to incision
Drug: Cefazolin Preoperatively
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
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
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
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
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.
| Milestone | 24 Hour Post-operative Course of Cefazolin | Pre-operative Single Dose of Cefazolin. |
|---|---|---|
| Started | 10 | 8 |
| Completed | 10 | 8 |
| Not completed | 0 | 0 |
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.
| Participants | 24 Hour Post-operative Course of Cefazolin | Pre-operative Single Dose of Cefazolin. |
|---|---|---|
| Wound Complications | 3 | 2 |
Collected over 2 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 24 Hour Post-operative Course of Cefazolin | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Pre-operative Single Dose of Cefazolin. | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Age, Categorical(Participants) | 24 Hour Post-operative Course of Cefazolin | Pre-operative Single Dose of Cefazolin. | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 8 | 18 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | 24 Hour Post-operative Course of Cefazolin | Pre-operative Single Dose of Cefazolin. | Total |
|---|---|---|---|
| Female | 10 | 8 | 18 |
| Male | 0 | 0 | 0 |
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Aultman Health Foundation