Prophylactic antibiotic regimens in tumour surgery (PARITY): protocol for a multicentre randomised controlled study

Area of Science:

• Orthopaedic Oncology
• Surgical Infection Prevention
• Clinical Trials

Background:

• Limb salvage surgery with endoprosthetic reconstruction is standard for lower-extremity bone tumors.
• Deep postoperative infection is a significant risk with devastating outcomes.
• Current prophylactic antibiotic practices vary widely, with no established optimal regimen.

Purpose of the Study:

• To evaluate the effect of short versus long postoperative prophylactic antibiotic regimens on deep infection rates.
• To determine the optimal duration of antibiotic prophylaxis following lower-extremity bone tumor reconstruction.
• To improve patient outcomes and reduce complications in limb salvage surgery.

Main Methods:

• A multicentre, blinded, randomised controlled trial involving 920 patients.
• Patients received either 24-hour or 5-day postoperative prophylactic antibiotics.
• Primary outcome: incidence of deep postoperative infections; secondary outcomes: adverse events, functional outcomes, quality of life, reoperation, and mortality.

Main Results:

• The study is ongoing and results are pending.
• The primary outcome will compare deep infection rates between the two antibiotic duration arms.
• Secondary outcomes will provide comprehensive data on safety and patient-centered endpoints.

Conclusions:

• This trial will provide crucial evidence to guide antibiotic prophylaxis duration in limb salvage surgery for bone tumors.
• Findings are expected to significantly impact clinical practice and enhance patient quality of life.
• The study aims to establish a best practice for preventing deep infections in this high-risk patient population.