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OpenTrials
Completed

NCT Number: NCT06664424

Adhesive Strips Vs Sutures in Skin Closure for Lumbar Spinal Fusion

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Diakonie Klinikum Stuttgart

Stuttgart, Baden-Wurttemberg, 70176, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Surgical site infections

    Time frame: 30 days

    Surgical site infections suspected by clinical signs, and confirmed by culture.

Sponsors and collaborators

Lead sponsor

Diakonie-Klinikum Stuttgart

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Oct 29, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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