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Completed

NCT Number: NCT05430308

Surgical Site Preparation in Subjects Undergoing Medical Thoracoscopy

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bronchoscopy suite, Chandigarh, India

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About this study

Medical thoracoscopy is the preferred procedure for performing pleural biopsy in patients with pleural effusions that remain undiagnosed after pleural fluid analysis. Unlike video-assisted thoracoscopic surgery that is performed under general anesthesia and single lung ventilation, medical thoracoscopy is performed under conscious sedation and local anesthesia. Medical thoracoscopy is generally a safe procedure, albeit with a small risk of complications. Surgical site infections (SSI) and empyema are among the important complications of the procedure. Author's center is a tertiary care referral hospital; the majority of the patients are referred to the authors' center late in the course of their illness. In fact, most patients have had several thoracenteses, and many patients have pleural adhesions. The authors have observed a significant incidence of post procedural infections (7.8-10%) in previous studies. In a recent RCT, investigators have demonstrated that the prophylactic use of antibiotics did not reduce the incidence of SSI. Since the patient's skin is a major source of pathogens, it is conceivable that improving skin antisepsis would decrease surgical-site infections. The aim of preoperative skin preparation is to reduce the risk of SSIs by removing soil and transient organisms from skin. Antiseptics have the ability to bind to the skin's stratum corneum that results in persistent chemical activity on the skin. A SSI occurs when the number of bacteria at the incision site overcome the hosts immune defense mechanism. The Centers for Disease Control and Prevention (CDC) recommends that 2% chlorhexidine-based preparations be used to cleanse the site of insertion of vascular catheters. However, the CDC has not issued a recommendation as to which antiseptics should be used preoperatively to prevent postoperative SSIs.

In a previous RCT comparing preoperative cleansing of the patient's skin, chlorhexidine-alcohol was found to be superior to cleansing with povidone-iodine for preventing surgical-site infection after clean contaminated surgery. However, in a pooled analysis of 13 RCTs comparing surgical site preparation for clean surgeries, no clear benefit could be demonstrated of either agent for preventing SSIs. Also, no published randomized studies have examined the effect of one antiseptic preparation over another on the incidence of surgical-site infection during medical thoracoscopy. A recent guideline on medical thoracoscopy has no mention about the preferred agent for skin preparation during MT. At the author's center, povidone-iodine is used for surgical site preparation during MT. The authors hypothesized that chlorhexidine-alcohol would be superior to povidone-iodine in reducing the rate of infectious complications following thoracoscopy. In this study, the investigators propose to investigate the efficacy of chlorhexidine-alcohol scrub in preventing post procedural infectious complications in subjects undergoing medical thoracoscopy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Chlorhexidine scrub

Procedure

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

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

Primary outcomes

  1. Occurrence of infection

    Time frame: 30 days

    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

Secondary outcomes

  1. Rate of adverse effects

    Time frame: 6 hours

    Adverse effects arising as a result of the use of either chlorhexidine-gluconate or povidone-iodine such as skin erythema, and rash

  2. Duration of chest tube drainage

    Time frame: 30 days

    Time from insertion of chest tube to removal of chest tube

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

A Randomized Controlled Study to Compare Chlorhexidine-Alcohol Versus Povidone-iodine for Surgical Site Preparation in Subjects Undergoing Medical Thoracoscopy for the Prevention of Infectious Complications

Acronym: CAPTAIN

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2022
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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