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Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures (CLNUP)

University of New Mexico (UNM) logo

University of New Mexico (UNM)

Status and phase

Completed
Phase 3

Conditions

Pelvic Floor Disorders
Urinary Tract Infections
Surgical Site Infection
Pelvic Organ Prolapse
Post-Op Infection
Gynecologic Disease
Urinary Incontinence

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full description

The purpose of this randomized controlled trial is to determine whether there is a difference in efficacy of two of the most common commercially available vaginal surgical preparations. The first objective is to determine whether chlorhexidine gluconate is non-inferior to povidone iodine with respect to post-operative infections including urinary tract infections (both culture proven and empirically treated) and surgical site infections (as defined by the Centers for Disease Control). The second objective is to determine whether chlorhexidine gluconate is non-inferior to povidone iodine with respect to vulvar and vaginal irritation.

Enrollment

137 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

137 participants in 2 patient groups

Chlorhexidine gluconate
Experimental group
Description:
Chlorhexidine gluconate 2% vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Treatment:
Drug: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Povidone Iodine
Active Comparator group
Description:
Povidone iodine vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Treatment:
Drug: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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