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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06664424

Enrollment

1016

Registered

2024-10-29

Start date

2019-01-01

Completion date

2023-01-30

Last updated

2024-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Spinal Fusion, Surgical Site Infections

Keywords

Lumbar spinal fusion surgery, surgical site infections, sutures, adhesive strips, non-inferiority study, wound infections, superficial wound infections

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Surgical site infections	30 days	Surgical site infections suspected by clinical signs, and confirmed by culture.

Countries

Germany

Outcome results