Suturing With U-Technique Versus Un-Reapproximated Wound Edges During Removal of Closed Thoracostomy Tube Drain
NCT ID: NCT04193241
Last Updated: 2020-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
142 participants
INTERVENTIONAL
2020-01-02
2021-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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
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
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Shalina Healthcare
INDUSTRY
University of Ibadan
OTHER
Responsible Party
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Lateef Ayodele Baiyewu, MD
LECTURER/HONORARY CONSULTANT CARDIOTHORACIC SURGEON
Principal Investigators
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Lateef A Baiyewu, MD,FWACS
Role: PRINCIPAL_INVESTIGATOR
College of Medicine University of Ibadan
Locations
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Division of Cardiothoracic Surgery,Department of Surgery, University College Hospital,
Ibadan, Oyo State, Nigeria
Countries
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Central Contacts
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Facility Contacts
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References
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Bertholet JW, Joosten JJ, Keemers-Gels ME, van den Wildenberg FJ, Barendregt WB. Chest tube management following pulmonary lobectomy: change of protocol results in fewer air leaks. Interact Cardiovasc Thorac Surg. 2011 Jan;12(1):28-31. doi: 10.1510/icvts.2010.248716. Epub 2010 Oct 6.
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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NHREC/05/01/2008a
Identifier Type: REGISTRY
Identifier Source: secondary_id
UI/EC/18/0711
Identifier Type: -
Identifier Source: org_study_id
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