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Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03578965
Recruitment Status : Active, not recruiting
First Posted : July 6, 2018
Last Update Posted : May 7, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Premalignant Vulvar Lesion Benign Vulvar Lesion Drug: Cefazolin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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
Primary Purpose: Prevention
Official Title: Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions: A Double-Blinded Randomized Controlled Trial
Actual Study Start Date : July 13, 2018
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1: Antibiotic prophylaxis prior to skin incision
-Women randomized to prophylactic antibiotics will receive a cefazolin as per ACOG guidelines.
Drug: Cefazolin
-If patient has a penicillin allergy then clindamycin will be used. Prophylactic antibiotics should be administered prior to skin incision

No Intervention: Arm 1: No antibiotic prophylaxis prior to skin incision
-Women randomized to no antibiotic prophylaxis will not receive any antibiotics prior to skin incision.



Primary Outcome Measures :
  1. Vulvar wound complications compared between the two arms [ Time Frame: Within 30 days of surgery (estimated to be 30 days) ]

    -a) 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.



Secondary Outcome Measures :
  1. Clinical risk factors that correlate with vulvar wound complications as measured by demographic variables that predispose patients to infection [ Time Frame: Within 30 days of surgery (estimated to be 30 days) ]
    -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.

  2. Clinical risk factors that correlate with vulvar wound complications as measured by vulvar hygiene [ Time Frame: Within 30 days of surgery (estimated to be 30 days) ]
    • Patients will complete the Vulvar Hygiene Survey 2-3 weeks post surgery and the survey is split into two sections - prior to surgery and after surgery.
    • The prior to surgery survey asks 6 questions with yes/no answer choices. The questions ask the patient's doctor if he/she informed them about vulvar hygiene
    • The after surgery section asks 4 questions about if the patient performed specific vulvar hygienic procedures

  3. Incidence of adverse events to antibiotic use [ Time Frame: Within 30 days of surgery (estimated to be 30 days) ]
    -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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All women, >=18 and <=85 undergoing vulvar surgery.
  • Biopsy proven benign or premalignant lesion requiring surgical management.
  • Women of childbearing age will be required to have a negative human chorionic gonadotropin (HCG) test within seven days of surgery.
  • Scheduled to undergo surgical management for their vulvar disease supervised by a faculty member within the Division of OBGYN at Washington University School of Medicine
  • Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • Women scheduled to undergo a radical vulvectomy
  • Women scheduled to undergo a concomitant graft, flap or plastic surgery
  • Women <18 years of age or >=85 years of age
  • History of prior vulvar radiation
  • Inability to sign an informed consent form prior to registration on study
  • Inability to understand spoken or written English
  • Prisoner

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03578965


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Mary M Mullen, M.D. Washington University School of Medicine
Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03578965    
Other Study ID Numbers: 201804136
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Precancerous Conditions
Neoplasms
Cefazolin
Anti-Bacterial Agents
Anti-Infective Agents