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| ID | Type | Description | Link |
|---|---|---|---|
| NHREC/05/01/2008a | Registry Identifier | UI/UCH ETHICS COMMITTEE |
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| Name | Class |
|---|---|
| Shalina Healthcare | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lateef A Baiyewu, MD,FWACS | Contact | +234 80 34455695 | bayan_latyph@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Lateef A Baiyewu, MD,FWACS | College of Medicine University of Ibadan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiothoracic Surgery,Department of Surgery, University College Hospital, | Recruiting | Ibadan | Oyo State | Nigeria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24340246 | Background | 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. | |
| 19022041 | Background |
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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.
6 months
By email request or paper request to the address of the Principal investigator as indicated above
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 16, 2019 |
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142 patients will be randomly assigned into two parallel groups of 71 each for each arm of the intervention
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WinPepi software will be used to randomly assign the participants into either of the two arms of intervention
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| 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 |
| Monaghan 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. |
| 20370923 | Background | Dural 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. |
| 30109204 | Background | Kim 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. |
| 28203426 | Background | Yokoyama 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. |
| 28979437 | Background | Chadwick 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. |
| 10148363 | Background | Gilbert 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. |
| 20926462 | Background | 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. |
| 15063299 | Background | Vasseur 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. |
| 29223423 | Background | Smelt 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. |
| 9817175 | Background | Rashid 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. |
| 22139619 | Background | Bosman 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. |
| 9217527 | Background | Chan 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. |
| 2810412 | Background | Helling 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. |
| 28222776 | Background | Walming 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. |
| 9329936 | Background | Singer AJ, Hollander JE, Quinn JV. Evaluation and management of traumatic lacerations. N Engl J Med. 1997 Oct 16;337(16):1142-8. doi: 10.1056/NEJM199710163371607. No abstract available. |
| 25158874 | Background | Yag-Howard C. Sutures, needles, and tissue adhesives: a review for dermatologic surgery. Dermatol Surg. 2014 Sep;40 Suppl 9:S3-S15. doi: 10.1097/01.DSS.0000452738.23278.2d. |
| 25867989 | Background | Burkhardt R, Lang NP. Influence of suturing on wound healing. Periodontol 2000. 2015 Jun;68(1):270-81. doi: 10.1111/prd.12078. |
| 19902850 | Background | Sonmez K, Bahar B, Karabulut R, Gulbahar O, Poyraz A, Turkyilmaz Z, Sancak B, Basaklar AC. Effects of different suture materials on wound healing and infection in subcutaneous closure techniques. B-ENT. 2009;5(3):149-52. |
| 20873303 | Background | Mirkovic S, Selakovic S, Sarcev I, Bajkin B. Influence of surgical sutures on wound healing. Med Pregl. 2010 Jan-Feb;63(1-2):7-14. doi: 10.2298/mpns1002007m. English, Serbian. |
| 2961498 | Background | Scheidel P, Hohl MK. Modern synthetic suture materials and abdominal wound closure techniques in gynaecological surgery. Baillieres Clin Obstet Gynaecol. 1987 Jun;1(2):223-46. doi: 10.1016/s0950-3552(87)80052-4. |
| 26554107 | Background | Gazivoda D, Pelemis D, Vujaskovic G. A clinical study on the influence of suturing material on oral wound healing. Vojnosanit Pregl. 2015 Sep;72(9):765-9. doi: 10.2298/vsp140401064g. |
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| 25039547 | Background | Tejani C, Sivitz AB, Rosen MD, Nakanishi AK, Flood RG, Clott MA, Saccone PG, Luck RP. A comparison of cosmetic outcomes of lacerations on the extremities and trunk using absorbable versus nonabsorbable sutures. Acad Emerg Med. 2014 Jun;21(6):637-43. doi: 10.1111/acem.12387. |
| 8180934 | Background | Helfman T, Ovington L, Falanga V. Occlusive dressings and wound healing. Clin Dermatol. 1994 Jan-Mar;12(1):121-7. doi: 10.1016/0738-081x(94)90262-3. No abstract available. |
| 10149169 | Background | Rovee DT. Evolution of wound dressings and their effects on the healing process. Clin Mater. 1991;8(3-4):183-8. doi: 10.1016/0267-6605(91)90030-j. |
| 7606367 | Background | Kannon GA, Garrett AB. Moist wound healing with occlusive dressings. A clinical review. Dermatol Surg. 1995 Jul;21(7):583-90. doi: 10.1111/j.1524-4725.1995.tb00511.x. |
| 1674265 | Background | Hutchinson JJ, Lawrence JC. Wound infection under occlusive dressings. J Hosp Infect. 1991 Feb;17(2):83-94. doi: 10.1016/0195-6701(91)90172-5. |
| 24371980 | Background | Triller C, Huljev D, Planinsek Rucigaj T. [Modern wound dressings]. Acta Med Croatica. 2013 Oct;67 Suppl 1:81-7. Croatian. |
| 21288353 | Background | Abramson JH. WINPEPI updated: computer programs for epidemiologists, and their teaching potential. Epidemiol Perspect Innov. 2011 Feb 2;8(1):1. doi: 10.1186/1742-5573-8-1. |
| 18487245 | Background | Breivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad L, Hals EK, Kvarstein G, Stubhaug A. Assessment of pain. Br J Anaesth. 2008 Jul;101(1):17-24. doi: 10.1093/bja/aen103. Epub 2008 May 16. |
| Dec 9, 2019 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D010996 | Pleural Effusion |
| D011030 | Pneumothorax |
| D013898 | Thoracic Injuries |
| D010995 | Pleural Diseases |
| D002916 | Chylothorax |
| D004653 | Empyema |
| D016724 | Empyema, Pleural |
| D013896 | Thoracic Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D014947 | Wounds and Injuries |
| D013492 | Suppuration |
| D007239 | Infections |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012141 | Respiratory Tract Infections |
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