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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cefazolin Preoperatively | Active Comparator | Participants received Cefazolin 2 grams intravenously within 30 minutes prior to incision |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefazolin PostOperatively | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael P Hopkins, MD | Aultman Health Foundation | Study Chair |
| William T. Schnettler, MD | Aultman Health Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aultman Health Foundation | Canton | Ohio | 44710 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Pre-operative Single Dose of Cefazolin. | Patients randomized to the standard pre-operative single dosing regimen of Cefazolin. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Pre-operative Single Dose of Cefazolin. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants who received their assigned dose of each intervention and completed all study visits were included in the efficacy analysis. | Posted | Count of Participants | Participants | Two-week post-operative |
|
2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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Small number of subjects recruited lead to unreliable data. A larger sample is needed to answer the research question.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jane Sewell | Aultman Health Foundation | 330-363-6793 | Jane.Sewell@aultman.com |
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| ID | Term |
|---|---|
| D014946 | Wound Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D002437 | Cefazolin |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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|
|
| Cefazolin Preoperatively | Drug | 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. |
|
|
Patients randomized to the standard pre-operative single dosing regimen of Cefazolin.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Patients randomized to the standard pre-operative single dosing regimen of Cefazolin.
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Pre-operative Single Dose of Cefazolin. | Patients randomized to the standard pre-operative single dosing regimen of Cefazolin. | 0 | 8 | 0 | 8 | 0 | 8 |
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| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |