Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT05430308 |
Other study ID # |
INT/IEC/2018/000151 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.