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

NCT03729947 | Completed

• 1 other identifier: 95/2018
• Study Type: interventional
• Target: 90
• Locations: 2 countries
• Sites: 3

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. 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.

Conditions

Adolescent Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (2)

• Postoperative change in Hemoglobin

  Hemoglobin

  Postoperative days 1-3

• Postoperative pain

  Visual analogue scale

  Postoperative days 1-3

Secondary Outcomes (1)

• Postoperative use of opioids using patient controlled analgesia

  Postoperative days 1-2

Study Arms (2)

Drain placed

ACTIVE COMPARATOR

Subfascial drain at end of procedure

Device: Subfascial closed suction drain

No drain placed

PLACEBO COMPARATOR

No drain left at the end of study

Device: Subfascial closed suction drain

Interventions

Subfascial closed suction drain DEVICE

Ch 14 closed suction drain

Also known as: No other

Drain placed; No drain placed

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Turku University Hospital: lead
• Karolinska Institutet: collaborator
• Kuopio University Hospital: collaborator

Study Sites (3)

Turku University Hospital

Turku, 20521, Finland

Location

Turku Children's Hospital

Turku, FI-20521, Finland

Location

Karolinska Institutet

Stockholm, Sweden

Location

Study Officials

• Ilkka J Helenius, MD, Prof

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatric Orthopedics

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: November 5, 2018
• Study Start: November 1, 2018
• Primary Completion: January 15, 2022
• Study Completion: January 15, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); FI (2)