An interventional study of Closure of chest tube wound in Pleural Effusion, Pneumothorax and Chest Trauma, sponsored by University of Ibadan. Status unknown at 1 site in Nigeria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-25.
Sponsored by University of Ibadan · Not applicable, Interventional, and Treatment
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.
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.
241 studies on the registry are indexed under Pleural Effusion; 50 are open to participants now.
This study's planned enrollment of 142 is above the median of 80 across 142 interventional studies indexed under Pleural Effusion.
Browse Pleural Effusion studies →University of Ibadan is the lead sponsor of 21 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients within the age limits who require chest tube insertion for any of the following indications:
Exclusion Criteria:
Any patient so described above who has the following will be excluded:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Also known as: Thoracostomy wound closure
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)
Time frame: 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")
Time frame: 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")
Time frame: 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)
Time frame: 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
Time frame: 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")
Time frame: 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
Time frame: It will span the period from chest tube removal till the patient is discharged home after chest tube removal
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
Time frame: After discharge from the hospital till 3 months after discharge
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: 6 months
Access criteria: By email request or paper request to the address of the Principal investigator as indicated above
Started Jan 2020 (actual). Primary completion is estimated for Dec 2020, 11 months after the start.
Of 61 non-industry interventional studies with no phase under Pleural Effusion, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 52. This study's planned 11 months is below that.
Counting every sponsor, half of 63 studies reached it within 26 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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University of Ibadan