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A randomized control trial will provide the most reliable data to determine the role of prophylactic antibiotics to decrease the wound complication rate. The investigators plan to perform a pilot study to evaluate actual rates of wound complications and how long it takes to recruit 50 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: No antibiotic prophylaxis prior to skin incision | No Intervention | -Women randomized to no antibiotic prophylaxis will not receive any antibiotics prior to skin incision. | |
| Arm B: Antibiotic prophylaxis prior to skin incision | Experimental | -Women randomized to prophylactic antibiotics will receive a cefazolin as per ACOG guidelines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefazolin | Drug | -If patient has a penicillin allergy then clindamycin will be used. Prophylactic antibiotics should be administered prior to skin incision |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vulvar Wound Complications Compared Between the Two Arms | Wound complication will be defined as a composite outcome that includes wound breakdown, sterile site infection, hematoma, seroma diagnosed within 30 days after excision. Sterile Site Infection (SSI) - defined as purulent drainage, cellulitis, abscess, or a wound that requires drainage, debridement or antibiotics associated with a clinical diagnosis of infection. | Within 30 days of surgery (estimated to be 30 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Clinical risk factors could include history of diabetes, liver disease, human immunodeficiency virus, chronic kidney disease, congestive heart failure, chronic obstructive pulmonary disease, peripheral vasculature disease, dementia, connective tissues disease, leukemia, lymphoma, peptic ulcer disease, hypertension, steroid use, and use of other immunosuppressive medications. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary M Mullen, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | -Women randomized to no antibiotic prophylaxis will not receive any antibiotics prior to skin incision. |
| FG001 | Arm B: Antibiotic Prophylaxis Prior to Skin Incision | -Women randomized to prophylactic antibiotics will receive a cefazolin as per ACOG guidelines. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | -Women randomized to no antibiotic prophylaxis will not receive any antibiotics prior to skin incision. |
| BG001 | Arm B: Antibiotic Prophylaxis Prior to Skin Incision |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Vulvar Wound Complications Compared Between the Two Arms | Wound complication will be defined as a composite outcome that includes wound breakdown, sterile site infection, hematoma, seroma diagnosed within 30 days after excision. Sterile Site Infection (SSI) - defined as purulent drainage, cellulitis, abscess, or a wound that requires drainage, debridement or antibiotics associated with a clinical diagnosis of infection. | Posted | Count of Participants | Participants | Within 30 days of surgery (estimated to be 30 days) |
|
Adverse events were collected from start of treatment through 30 days after completion of study treatment (estimated to be 31 days)
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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 | Arm A: No Antibiotic Prophylaxis Prior to Skin Incision | -Women randomized to no antibiotic prophylaxis will not receive any antibiotics prior to skin incision. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary M. Mullen, M.D. | Washington University School of Medicine | 314-655-8750 | marymullen@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 10, 2020 | Aug 9, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002437 | Cefazolin |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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The principal investigator along with all members of the study team involved in data analysis as well as the patients will be blinded to the randomization group. The research assistant will disclose the randomization group to the anesthesiologist who will screen the patient for allergies and then obtain the appropriate antibiotics from the pharmacy and administer the antibiotics as appropriate. These will be administered prior to the procedure and so the surgeon will remain blinded to the administration
| Within 30 days of surgery (estimated to be 30 days) |
| Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications |
| Within 30 days of surgery (estimated to be 30 days) |
| Incidence of Adverse Events to Antibiotic Use | -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting. | Within 30 days of surgery (estimated to be 30 days) |
-Women randomized to prophylactic antibiotics will receive a cefazolin as per ACOG guidelines.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diagnosis of diabetes mellitus | Count of Participants | Participants |
|
| Diagnosis of HIV | Count of Participants | Participants |
|
| Immunosuppressive medications | Count of Participants | Participants |
|
| Steroid use | Count of Participants | Participants |
|
| Diagnosis of hypertension | Count of Participants | Participants |
|
| Diagnosis of congestive heart failure | Count of Participants | Participants |
|
| Diagnosis of cardiac valvular disease | Count of Participants | Participants |
|
| Diagnosis of coronary artery disease | Count of Participants | Participants |
|
| Diagnosis of chronic kidney disease | Count of Participants | Participants |
|
| Diagnosis of pulmonary disease | Count of Participants | Participants |
|
-Women randomized to prophylactic antibiotics will receive a cefazolin as per ACOG guidelines. |
|
|
| Secondary | Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection | Clinical risk factors could include history of diabetes, liver disease, human immunodeficiency virus, chronic kidney disease, congestive heart failure, chronic obstructive pulmonary disease, peripheral vasculature disease, dementia, connective tissues disease, leukemia, lymphoma, peptic ulcer disease, hypertension, steroid use, and use of other immunosuppressive medications. | The number analyzed for each row equals the number of participants who had the listed pre-existing condition or medication. | Posted | Count of Participants | Participants | Within 30 days of surgery (estimated to be 30 days) |
|
|
|
| Secondary | Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications |
| The number analyzed in the rows below do not match the overall number of participants analyzed in some categories because the participant did not answer the question on the survey. | Posted | Count of Participants | Participants | Within 30 days of surgery (estimated to be 30 days) |
|
|
|
| Secondary | Incidence of Adverse Events to Antibiotic Use | -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting. | Only participants in Arm B who received antibiotic prophylaxis are evaluable for this outcome measure | Posted | Number | adverse events | Within 30 days of surgery (estimated to be 30 days) |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 20 |
| 24 |
| EG001 | Arm B: Antibiotic Prophylaxis Prior to Skin Incision | -Women randomized to prophylactic antibiotics will receive a cefazolin as per ACOG guidelines. | 0 | 26 | 0 | 26 | 17 | 26 |
| Anal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemorrhoid | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Minimal pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Swollen sensation | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Vulvar infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Bloody discharge | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Discolored suture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Easy bruising | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Vulvar bleeding | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Vulvar discomfort | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Vulvar wound dehiscence | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Vulvar wound drainage | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Vulvar/vaginal discharge | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Vulvar/vaginal spotting | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Wound separation | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mood changes | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bladder prolapse | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Incontinence | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain with intercourse | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vaginal bleeding | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vulvar pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Arm and thigh itching | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lichen sclerosus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vulvar pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vulvar rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
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| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| No vulvar wound complication(s) |
|
| Immunosuppressive medications |
|
|
| Steroid use |
|
|
| Diabetes mellitus |
|
|
| Hypertension |
|
|
| Congestive heart failure |
|
|
| Cardiac valvular disease |
|
|
| Coronary artery disease |
|
|
| Chronic kidney disease |
|
|
| Pulmonary disease |
|
|
| No vulvar wound complication(s) |
|
| Chose to not sit and to lie/stand when possible = no |
|
|
| Regularly performed vulvar wound care = yes postop |
|
|
| Regularly performed vulvar wound care = no |
|
|
| Performed sitz baths or cleansed with a showerhead 2-3 times a day postop for 1-2 days |
|
|
| Performed sitz baths or cleansed with a showerhead 2-3 times per day postop for 3-7 days |
|
|
| Performed sitz baths or cleansed with a showerhead 2-3 times per day postop for 8-14 days |
|
|
| Performed sitz baths or cleansed with a showerhead 2-3 times per day postop for 14+ days |
|
|
| Performed sitz baths or cleansed with a showerhead 2-3 times per day postop for unknown # of days |
|
|
| Performed sitz baths or cleansed with a showerhead 2-3 times per day postop = no |
|
|
| Actively kept the vulva dry postop 1-2 days |
|
|
| Actively kept the vulva dry postop 3-7 days |
|
|
| Actively kept the vulva dry postop 8-14 days |
|
|
| Actively kept the vulva dry postop 14+ days |
|
|
| Actively kept the vulva dry postop for unknown # of days |
|
|
| Actively kept the vulva dry postop = no |
|
|
| Cleaned the vulva after urinating postop 1-2 days |
|
|
| Cleaned the vulva after urinating postop 3-7 days |
|
|
| Cleaned the vulva after urinating postop 8-14 days |
|
|
| Cleaned the vulva after urinating postop 14+ days |
|
|
| Cleaned the vulva after urinating postop for unknown # of days |
|
|
| Cleaned the vulva after urinating postop = no |
|
|
| Cleaned the vulva after having a bowel movement postop 1-2 days |
|
|
| Cleaned the vulva after having a bowel movement postop 3-7 days |
|
|
| Cleaned the vulva after having a bowel movement postop 8-14 days |
|
|
| Cleaned the vulva after having a bowel movement postop 14+ days |
|
|
| Cleaned the vulva after having a bowel movement postop for unknown # of days |
|
|
| Cleaned the vulva after having a bowel movement postop = no |
|
|