NCT04048356

Brief Summary

This is a randomized controlled trial to determine if there is a difference between chlorhexidine gluconate and povidone iodine vaginal preparations for urogynecological surgery post operative infections.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2019

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 2, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 7, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2021

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

July 10, 2023

Completed
Last Updated

July 10, 2023

Status Verified

June 1, 2023

Enrollment Period

1.6 years

First QC Date

August 2, 2019

Results QC Date

June 20, 2023

Last Update Submit

June 20, 2023

Conditions

Pelvic Organ ProlapseUrinary IncontinencePelvic Floor DisordersGynecologic DiseasePost-Op InfectionSurgical Site InfectionUrinary Tract Infections

Keywords

UrogynecologySurgeryAntiseptic Preparation

Outcome Measures

Primary Outcomes (1)

  • Rate of Urinary Tract Infection

    Urinary tract infection as defined by positive urine culture of \>10,000 cfu, or empirically treated symptoms.

    2 weeks post operatively

Secondary Outcomes (2)

  • Rate of Surgical Site Infection

    14 days postoperatively

  • Vaginal Irritation

    Post operative day 1

Study Arms (2)

Chlorhexidine gluconate

EXPERIMENTAL

Chlorhexidine gluconate 2% vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.

Drug: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.

Povidone Iodine

ACTIVE COMPARATOR

Povidone iodine vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.

Drug: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.

Interventions

Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.DRUG

Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.

Chlorhexidine gluconatePovidone Iodine

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female Subjects \>18 years of age
  • English or Spanish speaking/reading
  • Must be able to provide informed consent
  • Undergoing urogynecologic procedures or surgery

You may not qualify if:

  • Pregnant - all patients are verified regarding pregnancy status prior to gynecologic surgical intervention at all sites of surgery - for patients who are premenopausal and have a uterus, a urine pregnancy test is administered in the preoperative setting. Pregnancy status is also determined prior to this in the office setting by interview and patient provided history prior to offering surgery to the patient.
  • Inability to return for follow-up visits
  • No concurrent need for vaginal antisepsis, such as cases of sacral neuromodulation
  • Lack of telephone
  • Known allergy to either antiseptic agent
  • Prisoners will not be eligible to participate in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87106, United States

Location

Related Publications (1)

  • Rockefeller NF, Petersen TR, Komesu YM, Meriwether K, Dunivan G, Ninivaggio C, Jeppson PC. Chlorhexidine gluconate vs povidone-iodine vaginal antisepsis for urogynecologic surgery: a randomized controlled noninferiority trial. Am J Obstet Gynecol. 2022 Jul;227(1):66.e1-66.e9. doi: 10.1016/j.ajog.2021.12.260. Epub 2021 Dec 29.

    PMID: 34973179DERIVED

MeSH Terms

Conditions

Pelvic Organ ProlapseUrinary IncontinencePelvic Floor DisordersGenital Diseases, FemaleSurgical Wound InfectionUrinary Tract Infections

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPregnancy ComplicationsGenital DiseasesWound InfectionInfectionsPostoperative ComplicationsPathologic Processes

Results Point of Contact

Title
Peter Jeppson, site contact for study
Organization
University of New Mexico
pjeppson@salud.unm.edu
505-967-8428

Study Officials

  • Karen Taylor, BA

    University of New Mexico

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be anesthetized during the intervention and will not be informed of the arm of their randomization
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2019

First Posted

August 7, 2019

Study Start

July 15, 2019

Primary Completion

February 28, 2021

Study Completion

March 14, 2021

Last Updated

July 10, 2023

Results First Posted

July 10, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)