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

NCT04193241 | Unknown DMC

• 2 other identifiers: UI/EC/18/0711NHREC/05/01/2008a
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Chest tube insertion; Purse-string suture; occlusive adhesive-absorbent dressing; thoracostomy wound closure; wound complications; wound outcomes

Outcome Measures

Primary Outcomes (7)

• Number of participants with Proportion of clinical and wound complications with indwelling chest tube - SEVERE PAIN

  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

  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

  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

  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

  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

  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

  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 Outcomes (1)

• Number of participants with late wound complications after chest tube removal

  After discharge from the hospital till 3 months after discharge

Study Arms (2)

Conventional purse-string suture closure

ACTIVE COMPARATOR

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

Suture-less occlusive-absorbent dressing closure

EXPERIMENTAL

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

Interventions

Closure of chest tube wound PROCEDURE

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

Also known as: Thoracostomy wound closure

Conventional purse-string suture closure; Suture-less occlusive-absorbent dressing closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ibadan: lead
• Shalina Healthcare: collaborator

Study Sites (1)

Division of Cardiothoracic Surgery,Department of Surgery, University College Hospital,

Ibadan, Oyo State, Nigeria

RECRUITING

Related Publications (31)

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MeSH Terms

Conditions

Pleural Effusion; Pneumothorax; Thoracic Injuries; Pleural Diseases; Chylothorax; Empyema; Empyema, Pleural; Thoracic Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Wounds and Injuries; Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections

Study Officials

• Lateef A Baiyewu, MD,FWACS

  College of Medicine University of Ibadan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lateef A Baiyewu, MD,FWACS

CONTACT

+234 80 34455695; bayan_latyph@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: WinPepi software will be used to randomly assign the participants into either of the two arms of intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: LECTURER/HONORARY CONSULTANT CARDIOTHORACIC SURGEON

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

Study Record Dates

• First Submitted: November 29, 2019
• First Posted: December 10, 2019
• Study Start: January 2, 2020
• Primary Completion: December 31, 2020
• Study Completion: March 31, 2021
• Last Updated: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months
• Access Criteria: By email request or paper request to the address of the Principal investigator as indicated above

Locations

NG (1)