Clinical trial NCT06664424: Adhesive Strips Vs Sutures in Skin Closure for Lumbar Spinal Fusion
Official title: Non-Inferiority Analysis of Adhesive Strips Vs. Sutures in Lumbar Spinal Fusion: a Propensity Matched Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Site Infections
Lumbar Spinal Fusion
Keywords: Lumbar spinal fusion surgery
surgical site infections
sutures
adhesive strips
non-inferiority study
wound infections
superficial wound infections
Lead sponsor: Diakonie-Klinikum Stuttgart
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 1016
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of both genders, aged 18 years or older, who underwent lumbar spinal fusion surgery involving one or two segments, with skin closure performed using either sutures or adhesive strips.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Surgical site infections
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Diakonie Klinikum Stuttgart
state: Baden-Wurtemberg
Study officials:
affiliation: Diakonie Klinik Stuttgart
name: Edgar Santos-Marcial, P.D. Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boody BS, Jenkins TJ, Hashmi SZ, Hsu WK, Patel AA, Savage JW. Surgical Site Infections in Spinal Surgery. J Spinal Disord Tech. 2015 Dec;28(10):352-62. doi: 10.1097/BSD.0000000000000339.
citation: Zempsky WT, Zehrer CL, Lyle CT, Hedbloom EC. Economic comparison of methods of wound closure: wound closure strips vs. sutures and wound adhesives. Int Wound J. 2005 Sep;2(3):272-81. doi: 10.1111/j.1742-4801.2005.00130.x.
citation: Lazar HL, McCann J, Fitzgerald CA, Cabral HJ. Adhesive strips versus subcuticular suture for mediansternotomy wound closure. J Card Surg. 2011 Jul;26(4):344-7. doi: 10.1111/j.1540-8191.2011.01257.x. Epub 2011 May 9.
citation: Hall LT, Bailes JE. Using Dermabond for wound closure in lumbar and cervical neurosurgical procedures. Neurosurgery. 2005 Jan;56(1 Suppl):147-50; discussion 147-50. doi: 10.1227/01.neu.0000144170.39436.52.
citation: Asomugha EU, Miller JA, McLain RF. Surgical Site Infections in Posterior Lumbar Surgery: A Controlled-Cohort Study of Epidural Steroid Paste. Spine (Phila Pa 1976). 2017 Jan 1;42(1):63-69. doi: 10.1097/BRS.0000000000001668.
citation: Saeedinia S, Nouri M, Azarhomayoun A, Hanif H, Mortazavi A, Bahramian P, Yarandi KK, Amirjamshidi A. The incidence and risk factors for surgical site infection after clean spinal operations: A prospective cohort study and review of the literature. Surg Neurol Int. 2015 Sep 29;6:154. doi: 10.4103/2152-7806.166194. eCollection 2015.