Dermabond versus suture fixation for spinal cord stimulator trial lead anchoring: a randomized within-patient controlled trial
Abstract
Objective: To determine whether Dermabond (2-octyl cyanoacrylate) provides superior lead stability to suture for percutaneous spinal cord stimulator (SCS) trial leads, and whether migration reflects patient-level factors rather than anchoring method.
Design: Prospective, randomized, within-patient controlled trial (ClinicalTrials.gov NCT05914311).
Setting: Interventional Pain and Spine Medicine Center at an academic medical center.
Subjects: Forty-eight adults (96 leads) undergoing bilateral thoracic percutaneous SCS trial implantation.
Methods: Within each patient, one lead was randomized to Dermabond and the contralateral lead to suture. The primary outcome was absolute radiographic lead migration (mm) between placement and end-of-trial, both imaged upright. All analyses accounted for within-patient correlation; a post hoc non-inferiority framing used the a priori 9 mm clinically meaningful threshold.
Results: Mean absolute migration was 9.15 ± 14.49 mm (Dermabond) and 10.60 ± 17.42 mm (suture); the paired difference was −1.46 mm (95% CI, −6.73 to 3.81; P = .58), with the upper bound well below the 9 mm threshold. In adjusted analyses, male sex (+8.17 mm; P = .036) and prior spine surgery (+7.08 mm; P = .048) predicted greater migration; body mass index (BMI), age, and fixation method did not. Clinically significant (≥9 mm) migration occurred in 27.1% of Dermabond and 22.9% of suture leads (McNemar P = .77).
Conclusions: Dermabond was not superior to suture but showed clinically comparable stability, supporting it as a noninvasive alternative. The stronger signal was at the patient level: male sex and prior spine surgery, but not BMI, predicted migration. Future efforts to reduce migration should target patient-level drivers rather than anchor choice.
Clinical trial registration number: ClinicalTrials.gov NCT05914311 (registered a priori).
Related
- Transfascial Paraspinal Versus Conventional Open Posterior Pedicle Screw Fixation for Thoracolumbar Fractures: A Randomized Controlled Trial
- Percutaneous vs. open screw fixation for medial malleolus fractures: a systematic review and meta-analysis of randomized controlled trials
- A Novel Anchoring Catheter Improves the Success, Efficiency, and Satisfaction of Paracentesis in Refractory Ascites: A Multicenter Randomized Crossover Trial
- A Tension-Controlled Arthroscopic Technique for Fixation of a Glenolabral Articular Disruption Lesion in an Overhead Athlete.
- Personalized assistive EMG-controlled virtual reality interface combined with cerebellar-iTBS for post-stroke arm recovery (ERICA): study protocol for a three-arm randomized controlled trial
BibTeX
@article{hurley2026dermabond,
title = {{Dermabond versus suture fixation for spinal cord stimulator trial lead anchoring: a randomized within-patient controlled trial}},
author = {Robert W Hurley and Janus S Patel and Daniel J Bintrim and Jennifer B Oliver and Amelia Miranda and Tiye Rahmah and Carlyle P Hamsher},
journal = {Pain Medicine: The Official Journal of the American Academy of Pain Medicine},
year = {2026},
month = jul,
doi = {10.1093/pm/pnag083},
url = {https://doi.org/10.1093/pm/pnag083},
note = {CC BY-NC-ND 4.0},
}
RIS
TY - JOUR
TI - Dermabond versus suture fixation for spinal cord stimulator trial lead anchoring: a randomized within-patient controlled trial
AU - Robert W Hurley
AU - Janus S Patel
AU - Daniel J Bintrim
AU - Jennifer B Oliver
AU - Amelia Miranda
AU - Tiye Rahmah
AU - Carlyle P Hamsher
PY - 2026
DA - 2026/07/03
JO - Pain Medicine: The Official Journal of the American Academy of Pain Medicine
DO - 10.1093/pm/pnag083
UR - https://doi.org/10.1093/pm/pnag083
AB - Objective: To determine whether Dermabond (2-octyl cyanoacrylate) provides superior lead stability to suture for percutaneous spinal cord stimulator (SCS) trial leads, and whether migration reflects patient-level factors rather than anchoring method. Design: Prospective, randomized, within-patient controlled trial (ClinicalTrials.gov NCT05914311). Setting: Interventional Pain and Spine Medicine Center at an academic medical center. Subjects: Forty-eight adults (96 leads) undergoing bilateral thoracic percutaneous SCS trial implantation. Methods: Within each patient, one lead was randomized to Dermabond and the contralateral lead to suture. The primary outcome was absolute radiographic lead migration (mm) between placement and end-of-trial, both imaged upright. All analyses accounted for within-patient correlation; a post hoc non-inferiority framing used the a priori 9 mm clinically meaningful threshold. Results: Mean absolute migration was 9.15 ± 14.49 mm (Dermabond) and 10.60 ± 17.42 mm (suture); the paired difference was −1.46 mm (95% CI, −6.73 to 3.81; P = .58), with the upper bound well below the 9 mm threshold. In adjusted analyses, male sex (+8.17 mm; P = .036) and prior spine surgery (+7.08 mm; P = .048) predicted greater migration; body mass index (BMI), age, and fixation method did not. Clinically significant (≥9 mm) migration occurred in 27.1% of Dermabond and 22.9% of suture leads (McNemar P = .77). Conclusions: Dermabond was not superior to suture but showed clinically comparable stability, supporting it as a noninvasive alternative. The stronger signal was at the patient level: male sex and prior spine surgery, but not BMI, predicted migration. Future efforts to reduce migration should target patient-level drivers rather than anchor choice. Clinical trial registration number: ClinicalTrials.gov NCT05914311 (registered a priori).
SN - 1526-2375
SN - 1526-4637
ER -