Surgical Site Preparation in Subjects Undergoing Medical Thoracoscopy

Medical Thoracoscopy Clinical Trial

— CAPTAIN  

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05430308
• Other study ID #: INT/IEC/2018/000151
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 18, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: September 2022
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age =12 <80 years

2. Medical thoracoscopy being performed for the workup of undiagnosed pleural effusion

Exclusion Criteria:

1. Patients with intercostal tube before MT

2. MT performed for adhesiolysis

3. Age <12 or =80 years

4. SPO2 <92% at room air

5. Hemodynamic instability

6. Myocardial infarction or unstable angina in the last 3 months

7. Hemoglobin <8g/dl; Platelet count <50,000 cell/dl

8. Lack of pleural space due to adhesions

9. Uncorrected coagulopathy (PT > 3 seconds above control; APTT> 10 seconds above control)

10. Failure to provide informed consent

11. Patients already taking any antibiotic due to any reason

Related Conditions & MeSH terms

• Medical Thoracoscopy

Intervention

Procedure:
• Chlorhexidine scrub
Surgical site selected for performing the thoracoscopy will be cleaned with 4%w/v chlorhexidine gluconate solution for 3 minutes
• Povidone-iodine
The surgical site selected for performing the thoracoscopy will be just cleaned with normal saline followed by 10% w/v povidone-iodine solution

Locations

Country	Name	City	State
India	Bronchoscopy suite	Chandigarh
India	Bronchoscopy suite, PGIMER	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of adverse effects	Adverse effects arising as a result of the use of either chlorhexidine-gluconate or povidone-iodine such as skin erythema, and rash	6 hours
Secondary	Duration of chest tube drainage	Time from insertion of chest tube to removal of chest tube	30 days