Suturing With U-Technique Versus Un-Reapproximated Wound Edges During Removal of Closed Thoracostomy Tube Drain — SUTURE  

Pleural Effusion Clinical Trial

Official title: Suturing With U-technique Versus Un-Reapproximated Wound Edges During Removal of Closed Thoracostomy Tube Drain - A Single-centre Open-label Randomized Prospective Trial (SUTURE TRIAL)

Status Recruiting

Clinical Trial Summary

The study will be carried out by the principal investigator and his team at the Division of Cardiovascular and Thoracic Surgery of the Department of Surgery, College of Medicine, University of Ibadan and the University College Hospital, Ibadan (UCH), which is the Teaching Hospital of the Medical College.The study sets out to prospectively compare the early and long-term outcomes between the use of purse-string (suturing U-technique) and Un-reapproximated thoracostomy wound edges (Occlusive adhesive-absorbent dressing application) at the time of removal of thoracostomy tube drain in patients who have had chest tube insertion.

Clinical Trial Description

Background: Closed thoracostomy tube drainage or chest tube insertion is one of the most commonly performed procedures in thoracic surgery. There are several published evidence-based guidelines on safe performance of a chest tube insertion. However, there is absence of any prospective controlled trial or systematic review, that scientifically proves the safest technique of closing the wound created at the time of chest tube insertion and that best guarantees good wound and overall outcomes, after chest tube removal. The use of a horizontal mattress non-absorbable suture or U- suture which is placed at the time of chest tube insertion and used to create a purse-string wound re-approximation at the time of tube removal, has been an age-long and time-honored practice in most thoracic surgical settings. It has been established by a fairly recent study that an occlusive adhesive-absorbent dressing can also be safely used to occlude the wound at the time of chest tube removal with good wound and overall outcomes though the study focused on tubes inserted during thoracic surgical operations.

Research Design: The study is an Open-label randomized prospective trial

Methodology: 142 consenting patients with indication for chest tube insertion, who meet the inclusion criteria for enrolment in the study will be randomly assigned into two balanced groups- Group A; that will have a Prolene 1 purse-string suture placed around the thoracostomy wound at the time of chest tube insertion and which will be used for the thoracostomy wound closure at the time of chest tube removal and Group B, that will not have a purse-string suture placement during chest tube insertion and will have their wounds covered by an occlusive adhesive-absorbent dressing material (Primapore*), at the time of chest tube removal. The procedure for chest tube insertion, indwelling chest tube management, post-tube removal care and outpatient follow-up; will be similar for both groups and will follow a pre-determined standardized protocol. Specific clinical outcomes while the chest tube is indwelling and specific clinical and wound outcomes after the chest tube removal will be observed in both Groups for comparison and to determine causal relationships. Observations will be recorded in a specially-designed study proforma. ;

Related Conditions & MeSH terms

• Chest Trauma
• Chylothorax
• Empyema
• Pleural Diseases
• Pleural Effusion
• Pneumothorax
• Pyothorax
• Thoracic Diseases
• Thoracic Injuries
• Thoracic Injury
• Thoracotomy
• Video-assisted Thoracoscopic Surgery

• NCT number: NCT04193241
• Study type: Interventional
• Source: University of Ibadan
• Contact: Lateef A Baiyewu, MD,FWACS
• Phone: +234 80 34455695
• Email: bayan_latyph@yahoo.com
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2020
• Completion date: March 31, 2021