Pleural Effusion Clinical Trial
— SUTUREOfficial 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.
Status | Recruiting |
Enrollment | 142 |
Est. completion date | March 31, 2021 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Nigeria | Division of Cardiothoracic Surgery,Department of Surgery, University College Hospital, | Ibadan | Oyo State |
Lead Sponsor | Collaborator |
---|---|
University of Ibadan | SHALINA HEALTHCARE |
Nigeria,
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* Note: There are 31 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Number of participants with late wound complications after chest tube removal | 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 |
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