Does Additional Use of Preoperative Azithromycin Decrease Posthysterectomy Infections

Summary

During hysterectomy bacteria may enter into the peritoneal cavity through vaginal opening and contaminate the healing tissues. The risk for deep infection after hysterectomy is about 5%. By reducing post-hysterectomy infections, it is possible to reduce individual burden of disease in addition to the direct and indirect financial costs. This study primary aim is to assess if prophylactic preoperative use of azithromycin in addition to generally used cefuroxime decreases post-hysterectomy infections as compared to cefuroxime only prophylaxis during 30 days after hysterectomy. Secondary aim is to assess if there is change in post-hysterectomy superficial infections, urinary tract infections, or post-operative fever between the cohorts and to report possible side-effects of the used antibiotics. In addition, the study finds out a possible role of bacterial vaginosis and microbiome n post-hysterectomy infections.

Conditions

• Infection Post Op
• Hysterectomy
• Antibiotics
• Prophylactic

Interventions

DRUG

Azithromycin Pill + Cefuroxime

Azithromycin 500 mg (2 tablets) per orally when arriving to the hospital before the operation and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose body mass index is 30 or more) in the operating theatre before the incision

DRUG

Placebo + Cefuroxime

Placebo (2 tablets) per orally in the evening when arriving to the hospital before the operation and a single dose Cefuroxime 1.5g (when body mass index is under 30) or 3g (for those whose body mass index is 30 or more) in the operating theatre before the incision

Sponsors & Collaborators

• University of Turku

  collaborator OTHER

• Tampere University Hospital

  collaborator OTHER

• Kuopio University Hospital

  collaborator OTHER

• Oulu University Hospital

  collaborator OTHER

• Jyväskylä Central Hospital

  collaborator OTHER

• Helsinki University Central Hospital

  lead OTHER

Principal Investigators

• Päivi Rahkola-Soisalo, Adj prof, MD · Helsinki University Central Hospital

• Tomi Mikkola, Prof, MD · Helsinki University Central Hospital

• Päivi Rahkola-Soisalo, Adj prof, MD · Helsinki University Central Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-05

Primary Completion

2025-12-31

Completion

2030-12-31

Countries

• Finland

Study Locations