Surgical Site Preparation in Subjects Undergoing Medical Thoracoscopy

NCT05430308 | Completed DMC

• 1 other identifier: INT/IEC/2018/000151
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Medical thoracoscopy is the preferred procedure for performing pleural biopsy in patients with pleural effusions that remain undiagnosed after pleural fluid analysis. Surgical site infections (SSI) and empyema are among the important complications of the procedure. At author's center, povidone-iodine is used for surgical site preparation during MT. The investigators hypothesized that chlorhexidine-alcohol would be superior to povidone-iodine in reducing the rate of infectious complications following thoracoscopy. In this study, the authors propose to investigate the efficacy of chlorhexidine-alcohol scrub in preventing post procedural infectious complications in subjects undergoing medical thoracoscopy

Conditions

Medical Thoracoscopy

Keywords

thoracoscopy; surgical site infection; pleuroscopy; thoracentesis

Outcome Measures

Primary Outcomes (1)

• Occurrence of infection

  surgical site indicated by development of a purulent discharge from the incision site or pleural space infection as indicated by development of purulent fluid, fall in glucose levels or Gram stain or culture positivity in the pleural fluid drained by the chest tube on the side of the procedure

  30 days

Secondary Outcomes (2)

• Rate of adverse effects

  6 hours

• Duration of chest tube drainage

  30 days

Study Arms (2)

Chlorhexidine-alcohol scrub

EXPERIMENTAL

The surgical site selected for performing the thoracoscopy will be cleaned with 4%w/v chlorhexidine gluconate solution for 3 minutes. This will then be washed with normal saline and a sterile gauge. After drying chlorhexidine gluconate (2.5%v/v)-ethanol IP (70%v/v) will be applied and allowed to dry for 3 minutes before the incision.

Procedure: Chlorhexidine scrub

Povidone-iodine

ACTIVE COMPARATOR

The surgical site selected for performing the thoracoscopy will be just cleaned with normal saline followed by 10% w/v povidone-iodine solution and would be allowed to dry for 3 minutes before the incision

Procedure: Povidone-iodine

Interventions

Chlorhexidine scrub PROCEDURE

Surgical site selected for performing the thoracoscopy will be cleaned with 4%w/v chlorhexidine gluconate solution for 3 minutes

Chlorhexidine-alcohol scrub

Povidone-iodine PROCEDURE

The surgical site selected for performing the thoracoscopy will be just cleaned with normal saline followed by 10% w/v povidone-iodine solution

Povidone-iodine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥12 \<80 years
• Medical thoracoscopy being performed for the workup of undiagnosed pleural effusion

You may not qualify if:

• Patients with intercostal tube before MT
• MT performed for adhesiolysis
• Age \<12 or ≥80 years
• SPO2 \<92% at room air
• Hemodynamic instability
• Myocardial infarction or unstable angina in the last 3 months
• Hemoglobin \<8g/dl; Platelet count \<50,000 cell/dl
• Lack of pleural space due to adhesions
• Uncorrected coagulopathy (PT \> 3 seconds above control; APTT\> 10 seconds above control)
• Failure to provide informed consent
• Patients already taking any antibiotic due to any reason

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (2)

Bronchoscopy suite

Chandigarh, Chandigarh, 160012, India

Location

Bronchoscopy suite, PGIMER

Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Povidone-Iodine

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Open labelled parallel study

Study Record Dates

• First Submitted: June 18, 2022
• First Posted: June 24, 2022
• Study Start: April 18, 2022
• Primary Completion: August 31, 2025
• Study Completion: October 31, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

IN (2)