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

Primary Purpose

Premalignant Vulvar Lesion, Benign Vulvar Lesion

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cefazolin
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Premalignant Vulvar Lesion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • All women, >=18 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
  • Women scheduled to undergo a radical vulvectomy
  • Women scheduled to undergo a concomitant graft, flap or plastic surgery
  • Women <18 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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Arm A: No antibiotic prophylaxis prior to skin incision

Arm B: Antibiotic prophylaxis prior to skin incision

Arm Description

-Women randomized to no antibiotic prophylaxis will not receive any antibiotics prior to skin incision.

-Women randomized to prophylactic antibiotics will receive a cefazolin as per ACOG guidelines.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications
Patients will complete the Vulvar Hygiene Survey 2-3 weeks post surgery. The after surgery section asks 6 questions about if the patient performed specific vulvar hygienic procedures
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.

Full Information

First Posted
June 25, 2018
Last Updated
October 26, 2022
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03578965
Brief Title
Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions
Official Title
Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions: A Double-Blinded Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 13, 2018 (Actual)
Primary Completion Date
November 23, 2021 (Actual)
Study Completion Date
November 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premalignant Vulvar Lesion, Benign Vulvar Lesion

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: No antibiotic prophylaxis prior to skin incision
Arm Type
No Intervention
Arm Description
-Women randomized to no antibiotic prophylaxis will not receive any antibiotics prior to skin incision.
Arm Title
Arm B: Antibiotic prophylaxis prior to skin incision
Arm Type
Experimental
Arm Description
-Women randomized to prophylactic antibiotics will receive a cefazolin as per ACOG guidelines.
Intervention Type
Drug
Intervention Name(s)
Cefazolin
Intervention Description
-If patient has a penicillin allergy then clindamycin will be used. Prophylactic antibiotics should be administered prior to skin incision
Primary Outcome Measure Information:
Title
Vulvar Wound Complications Compared Between the Two Arms
Description
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.
Time Frame
Within 30 days of surgery (estimated to be 30 days)
Secondary Outcome Measure Information:
Title
Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection
Description
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.
Time Frame
Within 30 days of surgery (estimated to be 30 days)
Title
Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications
Description
Patients will complete the Vulvar Hygiene Survey 2-3 weeks post surgery. The after surgery section asks 6 questions about if the patient performed specific vulvar hygienic procedures
Time Frame
Within 30 days of surgery (estimated to be 30 days)
Title
Incidence of Adverse Events to Antibiotic Use
Description
-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.
Time Frame
Within 30 days of surgery (estimated to be 30 days)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All women, >=18 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 Women scheduled to undergo a radical vulvectomy Women scheduled to undergo a concomitant graft, flap or plastic surgery Women <18 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary M Mullen, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

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

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