Surgical Site Preparation in Subjects Undergoing Medical Thoracoscopy

NCT ID: NCT05430308

Last Updated: 2022-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-18
• Study Completion Date: 2023-04-30

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

Detailed 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.

Conditions

Medical Thoracoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Chlorhexidine-alcohol scrub

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.

Group Type: EXPERIMENTAL

Chlorhexidine scrub

Intervention Type: PROCEDURE

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 and would be allowed to dry for 3 minutes before the incision

Group Type: ACTIVE_COMPARATOR

Povidone-iodine

Intervention Type: PROCEDURE

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

Interventions

Chlorhexidine scrub

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

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

Inderpaul singh

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bronchoscopy suite, PGIMER

Chandigarh, , India

Bronchoscopy suite

Chandigarh, , India

Countries

India

Other Identifiers

INT/IEC/2018/000151

Identifier Type: -

Identifier Source: org_study_id