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

Sponsor

University of Ibadan (Other)

Overall Status

Unknown status

CT.gov ID

NCT04193241

Collaborator

SHALINA HEALTHCARE (Other)

142

Enrollment

Location

Arms

14.9

Anticipated Duration (Months)

9.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pleural Effusion Pneumothorax Chest Trauma Video-assisted Thoracoscopic Surgery Thoracotomy Pleural Diseases Chylothorax Empyema Pyothorax Thoracic Diseases Thoracic Injury	Procedure: Closure of chest tube wound	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

142 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

142 patients will be randomly assigned into two parallel groups of 71 each for each arm of the intervention142 patients will be randomly assigned into two parallel groups of 71 each for each arm of the intervention

Masking:

None (Open Label)

Masking Description:

WinPepi software will be used to randomly assign the participants into either of the two arms of intervention

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Jan 2, 2020

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Mar 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional purse-string suture closure 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.	Procedure: Closure of chest tube wound At the time of chest tube removal, the chest tube site or thoracostomy wound will be closed in such a way as to prevent an iatrogenic pneumothorax or contamination of the pleural space Other Names: Thoracostomy wound closure
Experimental: Suture-less occlusive-absorbent dressing closure 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	Procedure: Closure of chest tube wound At the time of chest tube removal, the chest tube site or thoracostomy wound will be closed in such a way as to prevent an iatrogenic pneumothorax or contamination of the pleural space Other Names: Thoracostomy wound closure

Arm

Intervention/Treatment

Active Comparator: Conventional purse-string suture closure

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.

Procedure: Closure of chest tube wound

At the time of chest tube removal, the chest tube site or thoracostomy wound will be closed in such a way as to prevent an iatrogenic pneumothorax or contamination of the pleural space

Other Names:

Thoracostomy wound closure

Experimental: Suture-less occlusive-absorbent dressing closure

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

Procedure: Closure of chest tube wound

At the time of chest tube removal, the chest tube site or thoracostomy wound will be closed in such a way as to prevent an iatrogenic pneumothorax or contamination of the pleural space

Other Names:

Thoracostomy wound closure

Outcome Measures

Primary Outcome Measures

Number of participants with Proportion of clinical and wound complications with indwelling chest tube - SEVERE PAIN [It will span the period from chest tube insertion till chest tube removal]
Presence of severe pain at the chest tube site after chest tube insertion (Average daily pain score after tube insertion > 5 on the Visual Analog Scale and or Numerical Rating Scale)
Number of participants with clinical and wound complications with indwelling chest tube- TUBE DISLODGEMENT [It will span the period from chest tube insertion till chest tube removal]
Occurrence of tube dislodgement after chest tube insertion (expressed as "Present" or "Absent")
Number of participants with clinical and wound complications with indwelling chest tube - PERITUBAL LEAKAGE [It will span the period from chest tube insertion till chest tube removal]
Occurrence of peri-tubal leakage of fluid after chest tube insertion (expressed as "Present" or "Absent")
Number of participants with early wound complications after chest tube removal- AIR SUCK-IN [It will span the period from chest tube removal till the patient is discharged home after chest tube removal]
Presence of wound air suck-in after chest tube removal (indicated by presence of air suck-in sound through the wound into the pleural space during quiet and or forced inspiration)
Number of participants with early wound complications after chest tube removal- POST-INSERTION WOUND INFECTION [It will span the period from chest tube removal till the patient is discharged home after chest tube removal]
Occurrence of wound infection after chest tube removal (presence of purulent or offensive wound discharge with or without fever or presence of wound discharge that is microbiologically positive
Number of participants with early wound complications after chest tube removal- WOUND DEHISCENCE [It will span the period from chest tube removal till the patient is discharged home after chest tube removal]
Occurrence of wound dehiscence after chest tube removal (expressed as "Present" or "Absent")
Number of participants with early wound complications after chest tube removal- IATROGENIC PNEUMOTHORAX [It will span the period from chest tube removal till the patient is discharged home after chest tube removal]
Occurrence of early (within 7 days) and late pneumothorax (more than 1 week) after chest tube removal confirmed on chest radiography

Secondary Outcome Measures

Number of participants with late wound complications after chest tube removal [After discharge from the hospital till 3 months after discharge]
Development of raised or elevated thoracostomy wound scars (unsightly scars appearing like hypertrophic scars or keloids) within 3 months of chest tube removal

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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