NCT03729947: DAISY 2018

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

Completed NA Last updated 1 June 2022

What this trial tests

NA trial testing Subfascial closed suction drain in Adolescent Idiopathic Scoliosis in 90 participants. Completed in 15 January 2022.

Timeline

1 November 2018

Primary endpoint
15 January 2022

15 January 2022

Quick facts

Lead sponsor	Turku University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	90
Start date	1 November 2018
Primary completion	15 January 2022
Estimated completion	15 January 2022
Sites	3 locations across Sweden, Finland

Drugs / interventions tested

• Subfascial closed suction drain

Conditions studied

• Adolescent Idiopathic Scoliosis — all drugs for Adolescent Idiopathic Scoliosis →

Sponsor

Turku University Hospital

Who can join

Adults 10 to 21, any sex, with Adolescent Idiopathic Scoliosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.