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

U

University of Ibadan

Status

Unknown

Conditions

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

Treatments

Procedure: Closure of chest tube wound

Study type

Interventional

Funder types

Other

Identifiers

NCT04193241
UI/EC/18/0711
NHREC/05/01/2008a (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

142 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients within the age limits who require chest tube insertion for any of the following indications:

  • Pleural effusion
  • Traumatic or spontaneous pneumothorax
  • Traumatic haemothorax
  • As an adjunct to a thoracotomy for a non-neoplastic and or non -infective condition

Exclusion criteria

Any patient so described above who has the following will be excluded:

  • An associated pyopneumothorax
  • Cancer encuirasse of the chest wall
  • Unconscious with unclear consent situation
  • With infective or neoplastic conditions of the chest wall
  • With individual or family history of wound failure e.g. unsightly scars
  • Who has had irradiation of the chest or chemotherapy administration within 6 weeks from the time of requirement of the chest tube insertion
  • Who is at risk of immunosuppression i.e. diabetes, HIV infection, on steroid therapy, ongoing chemotherapy or who has a congenital or any other acquired immune deficiency state
  • Presence of pleural adhesion during the process of chest tube insertion
  • Those with chest tube malposition after insertion, confirmed on chest radiograph, who will require tube adjustment

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

142 participants in 2 patient groups

Conventional purse-string suture closure
Active Comparator group
Description:
A common-place conventional method of closure of chest tube or thoracostomy wound using a Prolene 1 purse-string suture (also known as U-suturing), at the time of chest tube removal.
Treatment:
Procedure: Closure of chest tube wound
Suture-less occlusive-absorbent dressing closure
Experimental group
Description:
Unconventional method of closing chest tube or thoracostomy wounds using Occlusive adhesive-absorbent dressing material (Primapore*) application i.e. Un-reapproximated wound edges, at time of chest tube removal
Treatment:
Procedure: Closure of chest tube wound

Trial documents
1

Trial contacts and locations

0

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Central trial contact

Lateef A Baiyewu, MD,FWACS

Data sourced from clinicaltrials.gov

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