A study comparing azithromycin with cefuroxime versus cefuroxime alone for preventing infections in patients undergoing hysterectomy

3 1 1

What is this study about?

This study focuses on preventing infections in patients undergoing hysterectomy, which is a surgical procedure to remove the uterus. The research aims to compare two different approaches to infection prevention: using a combination of two antibiotics (azithromycin and cefuroxime) versus using cefuroxime alone with placebo.

The study examines the effectiveness of different antibiotic combinations in preventing various types of infections that can occur after surgery. These infections may include complications in the surgical wound, pelvic area, urinary tract, and conditions involving fever. The research focuses specifically on infections that can develop within 30 days after the surgical procedure.

During the study, participants will receive either a combination of antibiotics or a single antibiotic with placebo. The medications will be given orally. The treatment period is short, consisting of a single day of medication administration. The study will monitor patients for any signs of infection or complications following their surgery.

1 Initial medication before surgery

You will receive either a combination of azithromycin and cefuroxime, or cefuroxime with a placebo tablet

The medication will be given orally (by mouth) before the hysterectomy (surgical removal of the uterus)

2 Surgery procedure

The hysterectomy will be performed according to standard medical procedures

The surgery will be conducted for non-cancerous (benign) conditions

3 Post-surgery monitoring – first 2 days

Your temperature will be monitored for fever (above 38°C/100.4°F)

Medical staff will check your surgical wound for any signs of infection

Your recovery will be monitored for any urinary tract infections

4 30-day follow-up period

Your surgical site will be monitored for both surface and deep wound infections

Any infections in the pelvic area will be documented

The monitoring period will continue for 30 days after your surgery

5 Study completion

The follow-up period ends after 30 days post-surgery

Your participation in the study will be complete after this monitoring period

Who Can Join the Study?

  • Must be a female patient
  • Must be an adult (18 years or older)
  • Must be scheduled to undergo a hysterectomy (surgical removal of the uterus) for non-cancerous conditions
  • Must not have any known allergies or other medical conditions that would prevent the use of azithromycin (an antibiotic medication) or cefuroxime (another type of antibiotic)
  • Must be having the surgery performed at a public hospital in Finland
  • Must be able to understand information provided in Finnish or Swedish languages
  • Must not be pregnant or breastfeeding
  • Must not belong to any vulnerable population groups

Who Cannot Join the Study?

  • Age below 18 years or above 65 years
  • Male patients (study is for females only)
  • Known allergy or hypersensitivity to azithromycin or cefuroxime (the antibiotics used in the study)
  • Currently having an active infection requiring antibiotic treatment
  • Pregnant or breastfeeding women
  • Having other surgical procedures planned alongside hysterectomy
  • Having taken antibiotics within 7 days before the planned surgery
  • Having a known immune system disorder (conditions that affect body’s ability to fight infections)
  • History of severe reactions to antibiotics
  • Having serious liver or kidney problems
  • Participation in another clinical trial within the last 30 days
  • Unable to provide informed consent

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Kuopio University Hospital Kuopio Finland

Other Sites

Site Name City Country Status
Oulu University Hospital Oulu Finland
Turku University Hospital Turku Finland
Pirkanmaan hyvinvointialue Tampere Finland
Hrjvgted Utmiqxpfou Ciyuloo Hyhpcdzv Helsinki Finland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Finland Finland
Recruiting
05.09.2022

Trial locations

Investigated drugs:

Azithromycin is an antibiotic medication that helps prevent and treat bacterial infections. It belongs to a group of antibiotics called macrolides and works by stopping the growth of bacteria. In this trial, it is used as a preventive measure against infections that may occur after hysterectomy surgery.

Cefuroxime is an antibiotic that fights bacteria in the body. It belongs to a group of medications called cephalosporin antibiotics. It works by preventing bacteria from building their cell walls, which helps stop infections. In this trial, it is used alone or in combination with azithromycin to prevent post-surgical infections following hysterectomy.

Investigated diseases:

Post-operative Surgical Site Infection – An infection that develops in the area of the surgical incision after a hysterectomy procedure. It can affect either the superficial layers of the skin or extend deeper into the surgical site. The infection typically develops within 30 days after surgery and may be accompanied by redness, swelling, and warmth around the incision site.

Pelvic Organ Infection – An infection that occurs in the pelvic region following gynecological surgery. It can affect various organs in the pelvic area and may develop gradually over several days or weeks after the operation. The condition can involve inflammation of the surrounding tissues in the pelvic cavity.

Urinary Tract Infection – An infection affecting any part of the urinary system, most commonly involving the bladder and urethra. The infection occurs when bacteria enter the urinary tract, causing inflammation and discomfort. Symptoms typically include frequent urination, burning sensation during urination, and cloudy urine.

Post-operative Fever – A sustained elevation in body temperature above 38°C (100.4°F) that persists for more than two days following surgery. This condition represents the body’s response to the surgical procedure or potential post-operative complications. The fever may be accompanied by general discomfort and increased heart rate.

Trial ID:
2024-517508-12-00
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study on Blood Flow in the Vaginal Area After Total Laparoscopic Hysterectomy Using Indocyanine Green for Patients Undergoing Hysterectomy

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France