Adhesive Strips Vs Sutures in Skin Closure for Lumbar Spinal Fusion

Completed

• Conditions: Surgical Site Infections; Lumbar Spinal Fusion

• Registration Number: NCT06664424
• Lead Sponsor: Diakonie-Klinikum Stuttgart

Brief 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.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2022-12-01
• Study Completion: 2023-01-30
• Status Verified: 2024-10
• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-10-28
• Last Update Submitted: 2024-10-28
• Study First Posted: 2024-10-29
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1016

Inclusion Criteria

• Patients undergoing spinal fusion surgery.
• Open posterior approach.
• Surgery involving one or two spinal segments.
• Patients aged 18 years or older.
• Skin closure performed using either sutures or adhesive strips.

Exclusion Criteria

• History of previous surgical site infections.
• Diagnosis of spondylodiscitis.
• Postoperative complications unrelated to surgical site infections.
• Deep surgical site infections (A3 classification).
• Patients undergoing surgeries other than lumbar spinal fusion.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Surgical site infections	30 days	Surgical site infections suspected by clinical signs, and confirmed by culture.

Trial Locations

Locations (1)

Diakonie Klinikum Stuttgart; 🇩🇪 Stuttgart, Baden-Wurtemberg, Germany