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

February 21, 2020 updated by: Lateef Ayodele Baiyewu, MD, University of Ibadan

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Nigeria
    • Oyo State
      • Ibadan, Oyo State, Nigeria
        • Recruiting
        • Division of Cardiothoracic Surgery,Department of Surgery, University College Hospital,
        • Contact:
        • Principal Investigator:
          • Lateef A Baiyewu, MD FWACS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

  1. Pleural effusion
  2. Traumatic or spontaneous pneumothorax
  3. Traumatic haemothorax
  4. 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:

  1. An associated pyopneumothorax
  2. Cancer encuirasse of the chest wall
  3. Unconscious with unclear consent situation
  4. With infective or neoplastic conditions of the chest wall
  5. With individual or family history of wound failure e.g. unsightly scars
  6. Who has had irradiation of the chest or chemotherapy administration within 6 weeks from the time of requirement of the chest tube insertion
  7. 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
  8. Presence of pleural adhesion during the process of chest tube insertion
  9. Those with chest tube malposition after insertion, confirmed on chest radiograph, who will require tube adjustment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with Proportion of clinical and wound complications with indwelling chest tube - SEVERE PAIN
Time Frame: 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)
It will span the period from chest tube insertion till chest tube removal
Number of participants with clinical and wound complications with indwelling chest tube- TUBE DISLODGEMENT
Time Frame: 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")
It will span the period from chest tube insertion till chest tube removal
Number of participants with clinical and wound complications with indwelling chest tube - PERITUBAL LEAKAGE
Time Frame: 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")
It will span the period from chest tube insertion till chest tube removal
Number of participants with early wound complications after chest tube removal- AIR SUCK-IN
Time Frame: 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)
It will span the period from chest tube removal till the patient is discharged home after chest tube removal
Number of participants with early wound complications after chest tube removal- POST-INSERTION WOUND INFECTION
Time Frame: 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
It will span the period from chest tube removal till the patient is discharged home after chest tube removal
Number of participants with early wound complications after chest tube removal- WOUND DEHISCENCE
Time Frame: 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")
It will span the period from chest tube removal till the patient is discharged home after chest tube removal
Number of participants with early wound complications after chest tube removal- IATROGENIC PNEUMOTHORAX
Time Frame: 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
It will span the period from chest tube removal till the patient is discharged home after chest tube removal

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with late wound complications after chest tube removal
Time Frame: 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
After discharge from the hospital till 3 months after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ibadan

Collaborators

SHALINA HEALTHCARE

Investigators

  • Principal Investigator: Lateef A Baiyewu, MD,FWACS, College of Medicine, University of Ibadan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 2, 2020

Primary Completion (ANTICIPATED)

December 31, 2020

Study Completion (ANTICIPATED)

March 31, 2021

Study Registration Dates

First Submitted

November 29, 2019

First Submitted That Met QC Criteria

December 9, 2019

First Posted (ACTUAL)

December 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 21, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UI/EC/18/0711
  • NHREC/05/01/2008a (UI/UCH ETHICS COMMITTEE)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

At the conclusion of the trial, the study protocol, analytical plan and informed consent will be available for a 6 month window for asses by other researchers, reviewers or statutory institutions by email request or paper request.

IPD Sharing Time Frame

6 months

IPD Sharing Access Criteria

By email request or paper request to the address of the Principal investigator as indicated above

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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