Pleural EffusionSUTURENCT04193241
Suturing With U-Technique Versus Un-Reapproximated Wound Edges During Removal of Closed Thoracostomy Tube Drain
A study testing Closure of chest tube wound in people with Pleural Effusion and Pneumothorax, run by University of Ibadan at 1 site in Nigeria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion, Pneumothorax, Chest Trauma
- What is being tested?
- Closure of chest tube wound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteNigeria
- Study dates
- 2 Jan 2020to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Nigeria1 site, 1 recruiting
- Recruiting
Division of Cardiothoracic Surgery,Department of Surgery, University College Hospital,
Ibadan, Oyo State
Lateef A Baiyewu, MD, FWACS, +234 8034455695, bayan_latyph@yahoo.com
Lateef A Baiyewu, MD FWACS
About this study
Official 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.
Read the 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.
- Conditions
- Pleural Effusion, Pneumothorax, Chest Trauma, Video-assisted Thoracoscopic Surgery, Thoracotomy, Pleural Diseases
- Being tested
- Closure of chest tube wound
- Keywords
- Chest tube insertion, Purse-string suture, occlusive adhesive-absorbent dressing, thoracostomy wound closure, wound complications, wound outcomes
- Medical subject headings
- Pleural Effusion, Pneumothorax, Thoracic Injuries, Pleural Diseases, Chylothorax, Empyema, Empyema, Pleural, Thoracic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closure of chest tube woundProcedure or surgery
Also called Thoracostomy wound closure
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: Closure of chest tube wound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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")
Measured: 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")
Measured: 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)
Measured: 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
Measured: 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")
Measured: 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
Measured: 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
Development of raised or elevated thoracostomy wound scars (unsightly scars appearing like hypertrophic scars or keloids) within 3 months of chest tube removal
Measured: After discharge from the hospital till 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start2 Jan 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 142 patients will be randomly assigned into two parallel groups of 71 each for each arm of the intervention
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ibadan
- Sponsor type
- University, hospital or other
- Collaborators
- Shalina Healthcare
- Responsible party
- Principal investigator, Lateef Ayodele Baiyewu, MD, University of Ibadan
- Investigators
- Lateef A Baiyewu, MD,FWACS, Principal investigator, College of Medicine University of Ibadan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193241
- Sponsor's protocol ID
- UI/EC/18/0711
- Other IDs
- NHREC/05/01/2008a
- Acronym
- SUTURE
- Status last verified
- Feb 2020
- First submitted
- 29 Nov 2019
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Martin M, Schall CT, Anderson C, Kopari N, Davis AT, Stevens P, Haan P, Kepros JP, Mosher BD. Results of a clinical practice algorithm for the management of thoracostomy tubes placed for traumatic mechanism. Springerplus. 2013 Dec 1;2:642. doi: 10.1186/2193-1801-2-642. eCollection 2013.
PubMed 24340246Monaghan SF, Swan KG. Tube thoracostomy: the struggle to the "standard of care". Ann Thorac Surg. 2008 Dec;86(6):2019-22. doi: 10.1016/j.athoracsur.2008.08.006.
PubMed 19022041Dural K, Gulbahar G, Kocer B, Sakinci U. A novel and safe technique in closed tube thoracostomy. J Cardiothorac Surg. 2010 Apr 6;5:21. doi: 10.1186/1749-8090-5-21.
PubMed 20370923Kim MS, Shin S, Kim HK, Choi YS, Kim J, Zo JI, Shim YM, Cho JH. Feasibility and Safety of a New Chest Drain Wound Closure Method with Knotless Sutures. Korean J Thorac Cardiovasc Surg. 2018 Aug;51(4):260-265. doi: 10.5090/kjtcs.2018.51.4.260. Epub 2018 Aug 5.
PubMed 30109204Yokoyama Y, Nakagomi T, Shikata D, Goto T. A novel technique for chest drain removal using a two layer method with triclosan-coated sutures. J Thorac Dis. 2017 Jan;9(1):211-213. doi: 10.21037/jtd.2017.01.31.
PubMed 28203426Chadwick AJ, Halfyard R, Ali M. Intercostal chest drains: Are you confident going on the pull? If not use the I-T-U approach. J Intensive Care Soc. 2015 Nov;16(4):312-325. doi: 10.1177/1751143715583856. Epub 2015 Apr 29.
PubMed 28979437Gilbert TB, McGrath BJ, Soberman M. Chest tubes: indications, placement, management, and complications. J Intensive Care Med. 1993 Feb-Mar;8(2):73-86. doi: 10.1177/088506669300800203.
PubMed 10148363Bertholet 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.
PubMed 20926462Vasseur BG. A simplified technique for closing thoracostomy incisions. Ann Thorac Surg. 2004 Apr;77(4):1467-8. doi: 10.1016/S0003-4975(03)01401-2.
PubMed 15063299Smelt JLC, Simon N, Veres L, Harrison-Phipps K, Bille A. The Requirement of Sutures to Close Intercostal Drains Site Wounds in Thoracic Surgery. Ann Thorac Surg. 2018 Feb;105(2):438-440. doi: 10.1016/j.athoracsur.2017.09.032. Epub 2017 Dec 7.
PubMed 29223423Rashid MA, Wikstrom T, Ortenwall P. A simple technique for anchoring chest tubes. Eur Respir J. 1998 Oct;12(4):958-9. doi: 10.1183/09031936.98.12040958.
PubMed 9817175Bosman A, de Jong MB, Debeij J, van den Broek PJ, Schipper IB. Systematic review and meta-analysis of antibiotic prophylaxis to prevent infections from chest drains in blunt and penetrating thoracic injuries. Br J Surg. 2012 Apr;99(4):506-13. doi: 10.1002/bjs.7744. Epub 2011 Dec 2.
PubMed 22139619Chan L, Reilly KM, Henderson C, Kahn F, Salluzzo RF. Complication rates of tube thoracostomy. Am J Emerg Med. 1997 Jul;15(4):368-70. doi: 10.1016/s0735-6757(97)90127-3.
PubMed 9217527Helling TS, Gyles NR 3rd, Eisenstein CL, Soracco CA. Complications following blunt and penetrating injuries in 216 victims of chest trauma requiring tube thoracostomy. J Trauma. 1989 Oct;29(10):1367-70. doi: 10.1097/00005373-198910000-00013.
PubMed 2810412Walming S, Angenete E, Block M, Bock D, Gessler B, Haglind E. Retrospective review of risk factors for surgical wound dehiscence and incisional hernia. BMC Surg. 2017 Feb 22;17(1):19. doi: 10.1186/s12893-017-0207-0.
PubMed 28222776
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT04193241
- Acronym / sponsor ID
- SUTURE / UI/EC/18/0711
- Conditions
- Pleural Effusion, Pneumothorax, Chest Trauma, Video-assisted Thoracoscopic Surgery, Thoracotomy, Pleural Diseases
- Keywords
- Chest tube insertion, Purse-string suture, occlusive adhesive-absorbent dressing, thoracostomy wound closure, wound complications, wound outcomes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- University of IbadanUniversity, hospital or other
- Collaborators
- Shalina Healthcare
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 142 patients will be randomly assigned into two parallel groups of 71 each for each arm of the intervention
| Arm | Type | Receives |
|---|---|---|
| Conventional purse-string suture closure | Active comparator | Procedure: Closure of chest tube woundA 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. |
| Suture-less occlusive-absorbent dressing closure | Experimental | Procedure: Closure of chest tube woundUnconventional 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closure of chest tube woundAlso: Thoracostomy wound closureAt 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 | Procedure or surgery | Conventional purse-string suture closure, Suture-less occlusive-absorbent dressing closure |
Primary outcome
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)
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")
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")
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)
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
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")
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
1 secondary outcome
Number of participants with late wound complications after chest tube removal
Time frame: After discharge from the hospital till 3 months after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Background: PubMed 24340246Martin M, Schall CT, Anderson C, Kopari N, Davis AT, Stevens P, Haan P, Kepros JP, Mosher BD. Results of a clinical practice algorithm for the management of thoracostomy tubes placed for traumatic mechanism. Springerplus. 2013 Dec 1;2:642. doi: 10.1186/2193-1801-2-642. eCollection 2013.
- Background: PubMed 19022041Monaghan SF, Swan KG. Tube thoracostomy: the struggle to the "standard of care". Ann Thorac Surg. 2008 Dec;86(6):2019-22. doi: 10.1016/j.athoracsur.2008.08.006.
- Background: PubMed 20370923Dural K, Gulbahar G, Kocer B, Sakinci U. A novel and safe technique in closed tube thoracostomy. J Cardiothorac Surg. 2010 Apr 6;5:21. doi: 10.1186/1749-8090-5-21.
- Background: PubMed 30109204Kim MS, Shin S, Kim HK, Choi YS, Kim J, Zo JI, Shim YM, Cho JH. Feasibility and Safety of a New Chest Drain Wound Closure Method with Knotless Sutures. Korean J Thorac Cardiovasc Surg. 2018 Aug;51(4):260-265. doi: 10.5090/kjtcs.2018.51.4.260. Epub 2018 Aug 5.
- Background: PubMed 28203426Yokoyama Y, Nakagomi T, Shikata D, Goto T. A novel technique for chest drain removal using a two layer method with triclosan-coated sutures. J Thorac Dis. 2017 Jan;9(1):211-213. doi: 10.21037/jtd.2017.01.31.
- Background: PubMed 28979437Chadwick AJ, Halfyard R, Ali M. Intercostal chest drains: Are you confident going on the pull? If not use the I-T-U approach. J Intensive Care Soc. 2015 Nov;16(4):312-325. doi: 10.1177/1751143715583856. Epub 2015 Apr 29.
- Background: PubMed 10148363Gilbert TB, McGrath BJ, Soberman M. Chest tubes: indications, placement, management, and complications. J Intensive Care Med. 1993 Feb-Mar;8(2):73-86. doi: 10.1177/088506669300800203.
- Background: PubMed 20926462Bertholet 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.
- Background: PubMed 15063299Vasseur BG. A simplified technique for closing thoracostomy incisions. Ann Thorac Surg. 2004 Apr;77(4):1467-8. doi: 10.1016/S0003-4975(03)01401-2.
- Background: PubMed 29223423Smelt JLC, Simon N, Veres L, Harrison-Phipps K, Bille A. The Requirement of Sutures to Close Intercostal Drains Site Wounds in Thoracic Surgery. Ann Thorac Surg. 2018 Feb;105(2):438-440. doi: 10.1016/j.athoracsur.2017.09.032. Epub 2017 Dec 7.
- Background: PubMed 9817175Rashid MA, Wikstrom T, Ortenwall P. A simple technique for anchoring chest tubes. Eur Respir J. 1998 Oct;12(4):958-9. doi: 10.1183/09031936.98.12040958.
- Background: PubMed 22139619Bosman A, de Jong MB, Debeij J, van den Broek PJ, Schipper IB. Systematic review and meta-analysis of antibiotic prophylaxis to prevent infections from chest drains in blunt and penetrating thoracic injuries. Br J Surg. 2012 Apr;99(4):506-13. doi: 10.1002/bjs.7744. Epub 2011 Dec 2.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lateef A Baiyewu, MD,FWACS principal investigator
College of Medicine University of Ibadan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closure of chest tube wound in people with Pleural Effusion and Pneumothorax, run by University of Ibadan at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lateef A Baiyewu, MD,FWACS (+234 80 34455695, bayan_latyph@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04193241, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.