Premalignant Vulvar LesionPhase 2NCT03578965
Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions
A Phase 2 study testing Cefazolin in people with Premalignant Vulvar Lesion and Benign Vulvar Lesion, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Premalignant Vulvar Lesion, Benign Vulvar Lesion
- What is being tested?
- Cefazolin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2018to 23 Nov 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions: A Double-Blinded Randomized Controlled Trial
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.
- Conditions
- Premalignant Vulvar Lesion, Benign Vulvar Lesion
- Being tested
- Cefazolin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefazolinDrug
-If patient has a penicillin allergy then clindamycin will be used. Prophylactic antibiotics should be administered prior to skin incision
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Cefazolin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 30 days of surgery (estimated to be 30 days)
Secondary outcomes (3)
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.
Measured: Within 30 days of surgery (estimated to be 30 days)
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
Measured: 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.
Measured: Within 30 days of surgery (estimated to be 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start13 Jul 2018
- Primary completion23 Nov 2021
- Study completion23 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Premalignant Vulvar LesionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary M Mullen, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578965
- Sponsor's protocol ID
- 201804136
- Status last verified
- Oct 2022
- First submitted
- 25 Jun 2018
- Last updated
- 21 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions: A Double-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03578965
- Acronym / sponsor ID
- 201804136
- Conditions
- Premalignant Vulvar Lesion, Benign Vulvar Lesion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 13 Jul 2018 (actual)
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 23 Nov 2021 (actual)
- First posted
- 6 Jul 2018 (actual)
- Results
- Posted 21 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Cefazolin-Women randomized to prophylactic antibiotics will receive a cefazolin as per ACOG guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cefazolin-If patient has a penicillin allergy then clindamycin will be used. Prophylactic antibiotics should be administered prior to skin incision | Drug | Arm B: Antibiotic prophylaxis prior to skin incision |
Primary outcome
Vulvar Wound Complications Compared Between the Two Arms
Time frame: Within 30 days of surgery (estimated to be 30 days)
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.
3 secondary outcomes
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)
Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications
Time frame: Within 30 days of surgery (estimated to be 30 days)
Incidence of Adverse Events to Antibiotic Use
Time frame: Within 30 days of surgery (estimated to be 30 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary M Mullen, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cefazolin in people with Premalignant Vulvar Lesion and Benign Vulvar Lesion, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vulvar Wound Complications Compared Between the Two Arms (time frame: Within 30 days of surgery (estimated to be 30 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.