Surgical Site Infection Clinical Trial
— VADEROfficial title:
Vacuum Drains vs Passive Drains vs no Drains in Decompressive Craniectomies - A Randomized Controlled Trial on Subgaleal Drain Complication Rates
NCT number | NCT03777774 |
Other study ID # | VADER 1.0 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2019 |
Est. completion date | June 30, 2020 |
Verified date | May 2021 |
Source | Universiti Sains Malaysia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This research is about the use of subgaleal drains to prevent accumulation of blood under the skin in patients undergoing surgery to remove part of the skull(craniectomy) and its associated complications. There have been early research that shows usage of subgaleal drains maybe related to increase in complication rates after craniectomy. These complications include hydrocephalus (accumulation of fluid in the brain), new hemorrhages, infection and low blood pressure. The investigators are performing this research to determine which type of subgaleal drains would produce the least complications. With this knowledge, the investigators would be able to reduce the amount of complications for future patients that undergo surgery to remove part of the skull. The purpose of this study is to determine the rate of complications in the 3 different groups of patients using the different types of drains under the skin in surgeries that involve removal of part of the skull. All participants will undergo the required surgery to remove part of the skull (craniectomy). Participants will then be randomly assigned to either one of 3 groups which are the vacuum drain group, passive drain group or no drain group.Participants in the vacuum drain group will have vacuum drains inserted during the closing stage of the surgery. Participants in the passive drain group will have passive drains inserted during the closing stage of the surgery. Participants in the no drain group will have a drain inserted during the closing stage of the procedure but the drain will remained closed. Data will then be collected and analysed to determine if the type of drains influence the rate of complications in craniectomy
Status | Completed |
Enrollment | 78 |
Est. completion date | June 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 80 Years |
Eligibility | Inclusion Criteria: - patients with indication for decompressive craniectomy as decided by the neurosurgeon in-charge. Indications maybe for traumatic intracranial bleed, spontaneous intracranial bleed and malignant middle cerebral artery territory infarction - Written informed consent by legal representative of patient Exclusion Criteria: - history of recent antiplatelet or anticoagulant use - patients with evidence of coagulopathy or thrombocytopenia from lab results - possible disseminated intravascular coagulation preoperatively - Presence of hydrocephalus preoperatively |
Country | Name | City | State |
---|---|---|---|
Malaysia | Hospital University Sains Malaysia | Kubang Kerian | Kelantan |
Malaysia | Sarawak General Hospital | Kuching | Sarawak |
Lead Sponsor | Collaborator |
---|---|
Universiti Sains Malaysia |
Malaysia,
Alexander P, Heels-Ansdell D, Siemieniuk R, Bhatnagar N, Chang Y, Fei Y, Zhang Y, McLeod S, Prasad K, Guyatt G. Hemicraniectomy versus medical treatment with large MCA infarct: a review and meta-analysis. BMJ Open. 2016 Nov 24;6(11):e014390. doi: 10.1136/bmjopen-2016-014390. Review. — View Citation
Anile C, De Bonis P, Di Chirico A, Ficola A, Mangiola A, Petrella G. Cerebral blood flow autoregulation during intracranial hypertension: a simple, purely hydraulic mechanism? Childs Nerv Syst. 2009 Mar;25(3):325-35; discussion 337-40. doi: 10.1007/s00381-008-0749-7. Epub 2009 Jan 17. — View Citation
Chang V, Hartzfeld P, Langlois M, Mahmood A, Seyfried D. Outcomes of cranial repair after craniectomy. J Neurosurg. 2010 May;112(5):1120-4. doi: 10.3171/2009.6.JNS09133. — View Citation
Choi SY, Yoon SM, Yoo CJ, Park CW, Kim YB, Kim WK. Necessity of Surgical Site Closed Suction Drain for Pterional Craniotomy. J Cerebrovasc Endovasc Neurosurg. 2015 Sep;17(3):194-202. doi: 10.7461/jcen.2015.17.3.194. Epub 2015 Sep 30. — View Citation
Cruse PJ, Foord R. A five-year prospective study of 23,649 surgical wounds. Arch Surg. 1973 Aug;107(2):206-10. — View Citation
De Bonis P, Pompucci A, Mangiola A, Rigante L, Anile C. Post-traumatic hydrocephalus after decompressive craniectomy: an underestimated risk factor. J Neurotrauma. 2010 Nov;27(11):1965-70. doi: 10.1089/neu.2010.1425. — View Citation
Ding J, Guo Y, Tian H. The influence of decompressive craniectomy on the development of hydrocephalus: a review. Arq Neuropsiquiatr. 2014 Sep;72(9):715-20. Review. — View Citation
Guangming Z, Huancong Z, Wenjing Z, Guoqiang C, Xiaosong W. Should epidural drain be recommended after supratentorial craniotomy for epileptic patients? Surg Neurol. 2009 Aug;72(2):138-41; discussion 141. doi: 10.1016/j.surneu.2008.06.014. — View Citation
Hemphill JC 3rd, Greenberg SM, Anderson CS, Becker K, Bendok BR, Cushman M, Fung GL, Goldstein JN, Macdonald RL, Mitchell PH, Scott PA, Selim MH, Woo D; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology. Guidelines for the Management of Spontaneous Intracerebral Hemorrhage: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Jul;46(7):2032-60. doi: 10.1161/STR.0000000000000069. Epub 2015 May 28. — View Citation
Honeybul S, Ho KM. Incidence and risk factors for post-traumatic hydrocephalus following decompressive craniectomy for intractable intracranial hypertension and evacuation of mass lesions. J Neurotrauma. 2012 Jul 1;29(10):1872-8. doi: 10.1089/neu.2012.2356. — View Citation
Honeybul S, Ho KM. Long-term complications of decompressive craniectomy for head injury. J Neurotrauma. 2011 Jun;28(6):929-35. doi: 10.1089/neu.2010.1612. Epub 2011 Jun 1. — View Citation
Huang X, Wen L. Technical considerations in decompressive craniectomy in the treatment of traumatic brain injury. Int J Med Sci. 2010 Nov 8;7(6):385-90. Review. — View Citation
Huang YH, Lee TC, Lee TH, Yang KY, Liao CC. Remote epidural hemorrhage after unilateral decompressive hemicraniectomy in brain-injured patients. J Neurotrauma. 2013 Jan 15;30(2):96-101. doi: 10.1089/neu.2012.2563. — View Citation
Hutchinson PJ, Kolias AG, Timofeev IS, Corteen EA, Czosnyka M, Timothy J, Anderson I, Bulters DO, Belli A, Eynon CA, Wadley J, Mendelow AD, Mitchell PM, Wilson MH, Critchley G, Sahuquillo J, Unterberg A, Servadei F, Teasdale GM, Pickard JD, Menon DK, Murray GD, Kirkpatrick PJ; RESCUEicp Trial Collaborators. Trial of Decompressive Craniectomy for Traumatic Intracranial Hypertension. N Engl J Med. 2016 Sep 22;375(12):1119-30. doi: 10.1056/NEJMoa1605215. Epub 2016 Sep 7. — View Citation
Jiao QF, Liu Z, Li S, Zhou LX, Li SZ, Tian W, You C. Influencing factors for posttraumatic hydrocephalus in patients suffering from severe traumatic brain injuries. Chin J Traumatol. 2007 Jun;10(3):159-62. — View Citation
Kosins AM, Scholz T, Cetinkaya M, Evans GRD. Evidence-based value of subcutaneous surgical wound drainage: the largest systematic review and meta-analysis. Plast Reconstr Surg. 2013 Aug;132(2):443-450. doi: 10.1097/PRS.0b013e3182958945. Review. — View Citation
Kurland DB, Khaladj-Ghom A, Stokum JA, Carusillo B, Karimy JK, Gerzanich V, Sahuquillo J, Simard JM. Complications Associated with Decompressive Craniectomy: A Systematic Review. Neurocrit Care. 2015 Oct;23(2):292-304. doi: 10.1007/s12028-015-0144-7. Review. — View Citation
Manfiotto M, Mottolese C, Szathmari A, Beuriat PA, Klein O, Vinchon M, Gimbert E, Roujeau T, Scavarda D, Zerah M, Di Rocco F. Decompressive craniectomy and CSF disorders in children. Childs Nerv Syst. 2017 Oct;33(10):1751-1757. doi: 10.1007/s00381-017-3542-7. Epub 2017 Sep 6. — View Citation
Meguro T, Terada K, Hirotsune N, Nishino S, Asano T. Postoperative extradural hematoma after removal of a subgaleal drainage catheter--case report. Neurol Med Chir (Tokyo). 2007 Jul;47(7):314-6. — View Citation
Meyerson JM. A Brief History of Two Common Surgical Drains. Ann Plast Surg. 2016 Jan;77(1):4-5. doi: 10.1097/SAP.0000000000000734. — View Citation
Morris AM. A controlled trial of closed wound suction. Br J Surg. 1973 May;60(5):357-9. — View Citation
Nalbach SV, Ropper AE, Dunn IF, Gormley WB. Craniectomy-associated Progressive Extra-Axial Collections with Treated Hydrocephalus (CAPECTH): redefining a common complication of decompressive craniectomy. J Clin Neurosci. 2012 Sep;19(9):1222-7. doi: 10.1016/j.jocn.2012.01.016. Epub 2012 Jun 20. — View Citation
Pandey S, Jin Y, Gao L, Zhou CC, Cui DM. Negative-Pressure Hydrocephalus: A Case Report on Successful Treatment Under Intracranial Pressure Monitoring with Bilateral Ventriculoperitoneal Shunts. World Neurosurg. 2017 Mar;99:812.e7-812.e12. doi: 10.1016/j.wneu.2016.12.049. Epub 2016 Dec 23. — View Citation
Powers AK, Neal MT, Argenta LC, Wilson JA, DeFranzo AJ, Tatter SB. Vacuum-assisted closure for complex cranial wounds involving the loss of dura mater. J Neurosurg. 2013 Feb;118(2):302-8. doi: 10.3171/2012.10.JNS112241. Epub 2012 Nov 16. — View Citation
Quinn TM, Taylor JJ, Magarik JA, Vought E, Kindy MS, Ellegala DB. Decompressive craniectomy: technical note. Acta Neurol Scand. 2011 Apr;123(4):239-44. doi: 10.1111/j.1600-0404.2010.01397.x. Review. — View Citation
Rahme R, Weil AG, Sabbagh M, Moumdjian R, Bouthillier A, Bojanowski MW. Decompressive craniectomy is not an independent risk factor for communicating hydrocephalus in patients with increased intracranial pressure. Neurosurgery. 2010 Sep;67(3):675-8; discussion 678. doi: 10.1227/01.NEU.0000383142.10103.0B. — View Citation
Roth J, Galeano E, Milla S, Hartmannsgruber MW, Weiner HL. Multiple epidural hematomas and hemodynamic collapse caused by a subgaleal drain and suction-induced intracranial hypotension: case report. Neurosurgery. 2011 Jan;68(1):E271-5; discussion E276. doi: 10.1227/NEU.0b013e3181fe6165. — View Citation
Shi SS, Zhang GL, Zeng T, Lin YF. Posttraumatic hydrocephalus associated with decompressive cranial defect in severe brain-injured patients. Chin J Traumatol. 2011;14(6):343-7. — View Citation
Sobani ZA, Shamim MS, Zafar SN, Qadeer M, Bilal N, Murtaza SG, Enam SA, Bari ME. Cranioplasty after decompressive craniectomy: An institutional audit and analysis of factors related to complications. Surg Neurol Int. 2011;2:123. doi: 10.4103/2152-7806.85055. Epub 2011 Sep 17. — View Citation
Takeuchi S, Nawashiro H, Wada K, Takasato Y, Masaoka H, Hayakawa T, Nagatani K, Otani N, Osada H, Shima K. Ventriculomegaly after decompressive craniectomy with hematoma evacuation for large hemispheric hypertensive intracerebral hemorrhage. Clin Neurol Neurosurg. 2013 Mar;115(3):317-22. doi: 10.1016/j.clineuro.2012.05.026. Epub 2012 Jun 21. — View Citation
Van Roost D, Thees C, Brenke C, Oppel F, Winkler PA, Schramm J. Pseudohypoxic brain swelling: a newly defined complication after uneventful brain surgery, probably related to suction drainage. Neurosurgery. 2003 Dec;53(6):1315-26; discussion 1326-7. — View Citation
Vedantam A, Yamal JM, Hwang H, Robertson CS, Gopinath SP. Factors associated with shunt-dependent hydrocephalus after decompressive craniectomy for traumatic brain injury. J Neurosurg. 2018 May;128(5):1547-1552. doi: 10.3171/2017.1.JNS162721. Epub 2017 Jun 16. — View Citation
Waziri A, Fusco D, Mayer SA, McKhann GM 2nd, Connolly ES Jr. Postoperative hydrocephalus in patients undergoing decompressive hemicraniectomy for ischemic or hemorrhagic stroke. Neurosurgery. 2007 Sep;61(3):489-93; discussion 493-4. — View Citation
Weintraub AH, Gerber DJ, Kowalski RG. Posttraumatic Hydrocephalus as a Confounding Influence on Brain Injury Rehabilitation: Incidence, Clinical Characteristics, and Outcomes. Arch Phys Med Rehabil. 2017 Feb;98(2):312-319. doi: 10.1016/j.apmr.2016.08.478. Epub 2016 Sep 23. — View Citation
Wilkie KP, Nagra G, Johnston M. A MATHEMATICAL ANALYSIS OF PHYSIOLOGICAL AND MOLECULAR MECHANISMS THAT MODULATE PRESSURE GRADIENTS AND FACILITATE VENTRICULAR EXPANSION IN HYDROCEPHALUS. Int J Numer Anal Model B. 2012;316:65-81. — View Citation
Yadav M, Nikhar SA, Kulkarni DK, Gopinath R. Cardiac Arrest after Connecting Negative Pressure to the Subgaleal Drain during Craniotomy Closure. Case Rep Anesthesiol. 2014;2014:146870. doi: 10.1155/2014/146870. Epub 2014 May 22. — View Citation
Yadav YR, Parihar V, Chourasia ID, Bajaj J, Namdev H. The role of subgaleal suction drain placement in chronic subdural hematoma evacuation. Asian J Neurosurg. 2016 Jul-Sep;11(3):214-8. doi: 10.4103/1793-5482.145096. — View Citation
Zhou L, Yu J, Sun L, Han Y, Wang G. Overdrainage after ventriculoperitoneal shunting in a patient with a wide depressed skull bone defect: The effect of atmospheric pressure gradient. Int J Surg Case Rep. 2016;29:11-15. doi: 10.1016/j.ijscr.2016.10.012. Epub 2016 Oct 15. — View Citation
* Note: There are 38 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Subgaleal hematomas | Mean maximum thickness and volume of subgaleal hematomas as post craniectomy complication. Defined as maximum thickness and volume (using XYZ/2 formula) of subgaleal hematoma on CT brain post craniectomy. | 24 hours +/- 12 hours post craniectomy | |
Secondary | New remote hematomas | Rate of new remote hematomas. Defined as hematomas not previously seen on earlier CT brains but seen on post operative CT brain that cannot be explained by direct connection or complication from the original hematomas | 1 week post craniectomy | |
Secondary | Surgical site infection | Rate of surgical site infection. Defined as purulent or serous discharge from the surgical site with clinical signs of inflammation | 1 month post craniectomy | |
Secondary | Wound breakdown | Rate of wound breakdown. Defined as spontaneous separation of sutured edges | 1 month post craniectomy | |
Secondary | Bradycardia or hypotension during skin closure stage. | Rate of bradycardia or hypotension during skin closure stage. Bradycardia defined as <60 beat per minute, hypotension defined as BP <90/60 mmHg, that cannot be clearly explained by other possible causes | end of surgery till 30 minutes after surgery has ended | |
Secondary | Post craniectomy hydrocephalus | Rate of post craniectomy hydrocephalus. Defined as radiographic and clinical evidence of hydrocephalus post craniectomy | 6 months post craniectomy | |
Secondary | Functional outcome | Modified Rankin Scale(MRS) score on 6 months post craniectomy
MRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead. |
6 months post craniectomy |
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