NCT06664424

Adhesive Strips Vs Sutures in Skin Closure for Lumbar Spinal Fusion

Non-Inferiority Analysis of Adhesive Strips Vs. Sutures in Lumbar Spinal Fusion: a Propensity Matched Retrospective Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,016 (actual)
• Sponsor: Diakonie-Klinikum Stuttgart · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Comparison between two methods for skin closure in lumbar spinal fusion surgery, a non-inferiority approach between sutures and adhesive strips and its effect on surgical site infections.

Detailed description

Surgical site infections (SSIs) are among the most common complications in spine surgery, the average rate of infection in spine surgery has been estimated to be around 2.1-3.1%, being the lumbar region the most prone to infection with a reported incidence of 3.7-6.9%. Wound management and the choice of materials used for skin closure can influence the rate of wound-related complications. This work is a retrospective, mono-centric analysis of data collected for surgical site infections (SSIs) surveillance in patients with lumbar spinal fusion surgery, the primary outcome is surgical site infections rate in the cohort and its relation to the wound closure method (Adhesive strips vs sutures). Using a propensity score matching and a non-inferiority analysis the objective was to determined if adhesive strips is not inferior to sutures regarding SSIs.

Conditions

• Surgical Site Infections
• Lumbar Spinal Fusion

Timeline

• Start date: 2019-01-01
• Primary completion: 2022-12-01
• Completion: 2023-01-30
• First posted: 2024-10-29
• Last updated: 2024-10-29

Locations

1 site across 1 country: Germany