Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03729947 |
| Other study ID # |
95/2018 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2018 |
| Est. completion date |
January 15, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
Turku University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Abstract Background - Closed suction drain is typically used worldwide after instrumented
posterior spinal fusion for adolescent idiopathic scoliosis (AIS). Postoperative drain
leakage has been associated with up to 50% of total blood loss in these patients. Previous
studies on adult patients with degenerative lumbar spine disorders have shown that leaving
out subfascial drain does not increase the risk of deep wound infection or epidural hematoma.
However, there has been no studies evaluating the need for subfascial drain in adolescents
undergoing instrumented spinal fusion for idiopathic scoliosis.
Study Design - A randomized, multicenter clinical trial on children and adolescents
undergoing posterior spinal fusion for idiopathic scoliosis using pedicle screw technique.
Ninety consecutive adolescents will be randomized into drain vs. no drain group at the time
of wound closure using the sealed envelope technique (1:1).
Aims and hypothesis - To compare drain vs. no drain use groups for the change in
postoperative hemoglobin or hematocrit in children undergoing posterior spinal fusion for
AIS. We hypothesize that postoperative hemoglobin change will be larger in the group
receiving subfascial drain and there will no change in the risk of postoperative
complications (deep surgical site infection, need for hematoma evacuation or other
re-operation) between the study groups.
Inclusion criteria - Adolescents (aged 10 to 21 years of age) undergoing surgery for
idiopathic scoliosis using pedicle screw technique.
Exclusion criteria - Coagulation disorder, smoking, unwilling to consent, vertebral column
resection, need for anteroposterior surgery.
Main outcome parametres - Postoperative change in hemoglobin or hematocrit; Secondary
parametres: need for blood transfusion, need for re-operation, need for change in the
dressings.
Ethical aspects - Ethical committee approval will be obtained both in Finland and in Sweden.
An informed consent will be obtained from all children and their parents. In case of major
intraoperative blood loss (>50% of blood volume) a subfascial drain can be inserted based on
the decision of the treating physician.
Time schedule and budget - This study will be started after ethical committee approval
(estimated 10/2018). There will be no extra costs as all information gathered will be part of
normal surgical treatment of AIS. A part-time research nurse has been hired to take care of
data collection into the database.
Description:
Background The use of a subfascial closed suction drain has been a long tradition in
adolescents undergoing posterior spinal fusion for idiopathic scoliosis.1-5 Drain has been
used to limit postoperative hematoma and epidural hematoma formation, to decrease risk of
postoperative deep wound infection, and to shorten hospital stay. Postoperative 24 hour drain
output has been larger than introperative blood loss in these patients.6 Previous studies in
adults undergoing total joint replacement have shown increased risk of hematocrit decrease
and blood transfusion, but better joint mobilization in patients treated with closed suction
drain as compared with those not receiving drain. In patients with lumbar degenerative
disorders drain use has been associated with higher risk of blood transfusion and longer
hospital stay.7-8 Leaving out subfascial drain has not been associated with increased risk of
deep surgical site infection or neurologic deficit, but the number of patients with
postoperative saturated dressings has been larger.1-5 There are no Level 1 studies evaluating
the need to use a subfascial closed suction drain or not in adolescents undergoing posterior
spinal fusion for idiopathic scoliosis.
Aims and hypothesis To compare postoperative Hemoglobin and hematocrit decrease, length of
hospital stay, and hematoma formation in patients receiving and not receiving subfascial
drain during posterior spinal fusion for idiopathic scoliosis. We hypothesize that children
not receiving a subfascial drain demonstrate smaller hemoglobin and hematocrit decrease
without increased risk of wound or neurologic complications.
Methods Study design - A randomised, multicentre clinical trial according to CONSORT
criteria.9 Patients - 90 adolescents undergoing posterior spinal fusion with pedicle screw
instrumentation for idiopathic scoliosis will be randomized at the time of wound closure
receiving a single subfascial drain (Hemovac 14 ch) or no drain.
Inclusion criteria - Patients will be included if they fulfilled the following criteria:
between ten and 21 years of age; no contraindication to the use of subfascial drain; suitable
for posterior scoliosis surgery using all pedicle screw technique for AIS (Lenke
classification10 Types 1 to 6); normal blood coagulation; a normal whole spine MRI except for
the spinal deformity (juvenile or AIS). Exclusion criteria - Need for anteroposterior
surgery; the need for vertebral resection; smoking; diabetes mellitus or abnormalities in
blood coagulation. Use of non-steroidal anti-inflammatory should be avoided within one week
of surgery.
Intervention - The intervention group will receive a single subfascial drain (Hemovac Ch14;
Zimmer, Warsaw, Indiana). The control group will not receive a drain.
Randomization - Randomization to intervention and control groups (1:1) will be carried out
using the sealed envelope technique at the time of wound closure.
Outcomes - The main outcome measures include postoperative decrease in hemoglobin, hematocrit
and the need for blood products (packed red cells, frozen plasma or platelets). Secondary
outcome measures include blood loss (mls), drain output over 24 hours (mls), total blood loss
(intra-operative blood loss + drain output); 48 hour opioid consumption (mg/kg); body
temperature during postoperative hospital stay; the number of patients with fully saturated
wound dressings requiring exchange will be recorded.
Surgery - Surgical planning of implant placement and the need for the Ponte procedure will be
carried out preoperatively. Each patient will be placed in the prone position and the
posterior elements will be exposed using electrocautery. The deformity will be corrected
using bilateral segmental pedicle screw instrumentation and en bloc vertebral column
derotation. Spinal fusion is carried out using autograft acquired from facetectomies and
osteotomies with bone graft extenders (Grafton, Medtronics Spinal and Biologics). Spinal cord
monitoring (MEP, SSEP, lumbar nerve root EMG with or without pedicle screw stimulation) will
be undertaken in all patients. A single subfascial drain (Hemovac Ch14; Zimmer, Warsaw,
Indiana) will be placed according to randomization during closure and will be removed at 24
hours post-operatively. A sterile wound dressing will be applied at the end of surgery. Wound
dressings will not be changed before discharge, until they are fully saturated.
Anaesthesia - All patients will have total intravenous anesthesia including dexmedetomidine,
propofol and remifentanil with the aim of achieving a mean arterial pressure between 65 mmHg
and 75 mmHg during surgery and for the first 24 hours post-operatively. Cefuroxime and
Vancomycin will be used as antibiotic prophylaxis.
All patients will receive an intravenous bolus of tranexamic acid (30 mg/kg, maximum dose
1500 mg) within 30 minutes before incision and then an infusion (10 mg/kg/h, maximum dose 500
mg/h) during surgery. Intra-operative blood loss will be measured and recorded as the amount
of blood collected in the cell saver, surgical wound dressings will be weighed during
surgery, excluding any irrigation with saline. The cell saver will be used in all patients
and the amount of autologous blood returned is recorded. Allogenic red blood cells will be
transfused if the Hb concentration goes below 80 g/L during surgery or during the hospital
stay. Fresh frozen plasma will be given if the blood loss exceeds 50% of the patients total
blood volume. Platelets will be infused if the blood loss is more than 100% of the blood
volume. The estimated blood volume will be calculated using a formula of 70 ml/kg x weight
(kg).12 Statistical power - The sample-size requirement of 30 patients per group was
calculated using a study power of 80%, a type I error (alpha) of 0.05, and an estimated
effect size of 0.7. Effect size evaluation was based on the assumption that mean (SD)
postoperative hemoglobin loss (the primary endpoint) would be 30 g/l (SD 14) for the control
group and 40 (SD 14) for the intervention group.6 We further expand the sample size
calculation by 16% to adjust the results for possible non-parametric methods. To accommodate
for possible drop outs during the follow-up 90 patients will be enrolled.
Ethical aspects Ethical committee approval will be obtained at our university hospital. If
the subfascial drain could not be used e.g. due to cerebrospinal fluid leakage or based on
the surgeon's judgment, leaving it will be allowed, however, the patient will remain in the
intervention group for statistical comparison according to the intention-to-treat principle.
Time schedule This study will be started after ethical committee approval estimated in the
beginning of 2019 and patient recruitment is estimated to be done by the end of 2023.
Budget Surgical treatment of adolescents with idiopathic scoliosis is according to the
standard practice. There will be no extra costs due to this study. A part-time research nurse
and PhD students will be hired using Valtion tutkimusrahoitus and external funding.
References
1. Brown MD, Brookfield KF. A randomized study of closed wound suction drainage for
extensive lumbar spine surgery Spine (Phila Pa 1976). 2004 May 15;29(10):1066-8.
2. Kanayama M, Oha F, Togawa D, Shigenobu K, Hashimoto T. Is closed-suction drainage
necessary for single-level lumbar decompression?: review of 560 cases. Clin Orthop Relat
Res. 2010 Oct;468(10):2690-4.
3. Zijlmans JL, Buis DR, Verbaan D, Vandertop WP. Wound drains in non-complex lumbar
surgery: a systematic review. Bone Joint J. 2016 Jul;98-B(7):984-9.
4. Liu Y, Li Y, Miao J. Wound drains in posterior spinal surgery: a meta-analysis. J Orthop
Surg Res. 2016 Jan 22;11:16.
5. Liu JM, Chen WZ, Fu BQ, Chen JW, Liu ZL, Huang SH. The Use of Closed Suction Drainage in
Lumbar Spinal Surgery: Is It Really Necessary? World Neurosurg. 2016 Jun;90:109-115.
6. Helenius I, Keskinen H, Syvänen J, Lukkarinen H, Mattila M, Välipakka J, Pajulo O.
Gelatine matrix with human thrombin decreases blood loss in adolescents undergoing
posterior spinal fusion for idiopathic scoliosis. A MULTICENTRE, RANDOMISED CLINICAL
TRIAL. Bone Joint J 2016;98-B:395-401.
7. Parker MJ, Roberts CP, Hay D. Closed suction drainage for hip and knee arthroplasty. A
meta-analysis. J Bone Joint Surg Am. 2004 Jun;86-A(6):1146-52
8. Zhang Q, Liu L, Sun W, Gao F, Zhang Q, Cheng L, Li Z. Are closed suction drains
necessary for primary total knee arthroplasty?: A systematic review and meta-analysis.
Medicine (Baltimore). 2018 Jul;97(30):e11290
9. Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT 2010 statement: updated guidelines
for reporting parallel group randomised trials. BMJ 2010;340:332.
10. Mattila M, Jalanko T, Helenius I. En bloc vertebral column derotation provides spinal
derotation but no additional effect on thoracic rib hump correction as compared with no
derotation in adolescents undergoing surgery for idiopathic scoliosis with total pedicle
screw instrumentation. Spine (Phila Pa 1976) 2013;38:1576-1583.
11. Lenke LG, Betz RR, Harms J, et al. Adolescent idiopathic scoliosis: a new classifi-
cation to determine extent of spinal arthrodesis. J Bone Joint Surg [Am] 2001;83-
A:1169-1181.
Cote CJ. Pediatric Anesthesia. In: Miller RD, Eriksson LI, Fleisher LA, Wiener-Kronish JP,
Young WL, eds. Miller's Anesthesia. Philadelphia: Churchill Livingstone; 2010:2559-2597.
