NCT05546762

Trial of Antiseptic Irrigation for Pleural Infection

IrRigation of the INfected Pleural Space With antiSEptic Solution (RINSE) - a Proof of Concept Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Pleural antiseptic irrigation (PAI) is used in conjunction with open drainage for treating adults with chronic post-thoracotomy empyema. The antiseptic povidone-iodine can safely be instilled into the pleural cavity for the purpose of pleurodesis and has recently been described for pleural irrigation in the acute management of paediatric pleural infection with good outcomes. A recent case report demonstrated the safe use of povidone-iodine pleural irrigation in a patient with complex pleural empyema with successful medical management. In a previous pilot study, antiseptic irrigation led to less referral to surgery and shorter length of hospital stay in comparison to no irrigation. This study aims to investigate the effect of antiseptic pleural irrigation (using povidone iodine) on the inflammatory response in adults patients with pleural infection in comparison to irrigation with normal saline alone. A reduction in the systemic inflammatory response can be inferred to correlate with reduction in the infection burden in the pleural space.

Conditions

• Empyema, Pleural

Interventions

Type	Name	Description
DRUG	Povidone-iodine solution	Pleural irrigation with 2% povidone iodine
DRUG	Normal saline	Pleural irrigation with normal saline

Timeline

• Start date: 2022-09-19
• Primary completion: 2024-04-01
• Completion: 2024-05-01
• First posted: 2022-09-21
• Last updated: 2022-09-27

Locations

1 site across 1 country: Egypt