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)
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.
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.
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