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

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.