NCT06664424

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,016

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2024

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

3.9 years

First QC Date

October 28, 2024

Last Update Submit

October 28, 2024

Conditions

Surgical Site InfectionsLumbar Spinal Fusion

Keywords

Lumbar spinal fusion surgerysurgical site infectionssuturesadhesive stripsnon-inferiority studywound infectionssuperficial wound infections

Outcome Measures

Primary Outcomes (1)

  • Surgical site infections

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

    30 days

Study Arms (2)

Adhesive strips group

Patients in whom adhesive strips were employed for skin closure

Suture group

Patients in whom sutures were employed for skin closure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diakonie Klinikum Stuttgart

Stuttgart, Baden-Wurttemberg, 70176, Germany

Location

Related Publications (6)

  • 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.

    PMID: 26566255BACKGROUND

  • 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.

    PMID: 16618333BACKGROUND

  • 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.

    PMID: 21554389BACKGROUND

  • 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.

    PMID: 15799803BACKGROUND

  • 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.

    PMID: 27135641BACKGROUND

  • 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.

    PMID: 26500800BACKGROUND

MeSH Terms

Conditions

Surgical Wound InfectionWound Infection

Condition Hierarchy (Ancestors)

InfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Edgar Santos-Marcial, P.D. Dr. med

    Diakonie Klinik Stuttgart

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2024

First Posted

October 29, 2024

Study Start

January 1, 2019

Primary Completion

December 1, 2022

Study Completion

January 30, 2023

Last Updated

October 29, 2024

Record last verified: 2024-10

Locations

DE(1)