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CLOSED SUCTION DRAIN VS. NO DRAIN IN ADOLESCENTS UNDERGOING PEDICLE SCREW INSTRUMENTATION FOR IDIOPATHIC SCOLIOSIS (DAISY 2018). A Randomized Clinical Trial (DAISY 2018)

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ClinicalTrials.gov Identifier: NCT03729947
Recruitment Status : Recruiting
First Posted : November 5, 2018
Last Update Posted : November 5, 2018
Sponsor:
Collaborators:
Karolinska Institutet
Kuopio University Hospital
Information provided by (Responsible Party):
Ilkka Helenius, Turku University Hospital

Brief 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. Sixty 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.


Condition or disease Intervention/treatment Phase
Adolescent Idiopathic Scoliosis Device: Subfascial closed suction drain Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CLOSED SUCTION DRAIN VS. NO DRAIN IN ADOLESCENTS UNDERGOING PEDICLE SCREW INSTRUMENTATION FOR IDIOPATHIC SCOLIOSIS (DAISY 2018). A Randomized Clinical Trial
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : October 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Arm Intervention/treatment
Active Comparator: Drain placed
Subfascial drain at end of procedure
Device: Subfascial closed suction drain
Ch 14 closed suction drain
Other Name: No other

Placebo Comparator: No drain placed
No drain left at the end of study
Device: Subfascial closed suction drain
Ch 14 closed suction drain
Other Name: No other




Primary Outcome Measures :
  1. Postoperative change in Hemoglobin [ Time Frame: Postoperative days 1-3 ]
    Hemoglobin

  2. Postoperative pain [ Time Frame: Postoperative days 1-3 ]
    Visual analogue scale


Secondary Outcome Measures :
  1. Postoperative use of opioids using patient controlled analgesia [ Time Frame: Postoperative days 1-2 ]
    Opioid consumption



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729947


Contacts
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Contact: Ilkka J Helenius, MD, Prof +358443380034 ilkka.helenius@tyks.fi
Contact: Linda L Helenius, MD +358503609291 linda.helenius@tyks.fi

Locations
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Finland
Turku University Hospital Recruiting
Turku, Finland, 20521
Contact: Linda Helenius, MD         
Turku Children's Hospital Recruiting
Turku, Finland, FI-20521
Contact: Ilkka J. Helenius, MD, PhD    +358-2-3130218    ilkka.helenius@tyks.fi   
Contact: Olli T. Pajulo, MD, PhD    +358-2+3130000    olli.pajulo@utu.fi   
Sub-Investigator: Olli Pajulo, MD, PhD         
Principal Investigator: Ilkka Helenius, MD, PhD         
Sweden
Karolinska Institutet Recruiting
Stockholm, Sweden
Contact: Paul Gerdhem, MD, Prof       paul.gerdhem@sll.se   
Sponsors and Collaborators
Turku University Hospital
Karolinska Institutet
Kuopio University Hospital
Investigators
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Principal Investigator: Ilkka J Helenius, MD, Prof Turku University Hospital
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Responsible Party: Ilkka Helenius, Professor of Pediatric Orthopedics, Turku University Hospital
ClinicalTrials.gov Identifier: NCT03729947    
Other Study ID Numbers: 95/2018
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases