Surgical Site InfectionsNCT06664424
Adhesive Strips Vs Sutures in Skin Closure for Lumbar Spinal Fusion
An observational study of Surgical Site Infections and Lumbar Spinal Fusion, run by Diakonie-Klinikum Stuttgart at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infections, Lumbar Spinal Fusion
- How many people
- 1,016 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2019to 30 Jan 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Inferiority Analysis of Adhesive Strips Vs. Sutures in Lumbar Spinal Fusion: a Propensity Matched Retrospective Study
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.
Read the 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.
- 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
- Medical subject headings
- Surgical Wound Infection, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adhesive strips group | Patients in whom adhesive strips were employed for skin closure | |
| Suture group | Patients in whom sutures were employed for skin closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infections
Surgical site infections suspected by clinical signs, and confirmed by culture.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Jan 2019
- Primary completion1 Dec 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,016 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Diakonie-Klinikum Stuttgart
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edgar Santos-Marcial, P.D. Dr. med, Principal investigator, Diakonie Klinik Stuttgart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664424
- Sponsor's protocol ID
- Diak 002/2024
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26566255Zempsky 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.
PubMed 16618333Lazar 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.
PubMed 21554389Hall 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.
PubMed 15799803Asomugha 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.
PubMed 27135641Saeedinia 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.
PubMed 26500800
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Inferiority Analysis of Adhesive Strips Vs. Sutures in Lumbar Spinal Fusion: a Propensity Matched Retrospective Study
- ClinicalTrials.gov ID
- NCT06664424
- Acronym / sponsor ID
- Diak 002/2024
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,016 participants (actual)
- Lead sponsor
- Diakonie-Klinikum StuttgartUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adhesive strips group | – | –Patients in whom adhesive strips were employed for skin closure |
| Suture group | – | –Patients in whom sutures were employed for skin closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Surgical site infections
Time frame: 30 days
Surgical site infections suspected by clinical signs, and confirmed by culture.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Background: PubMed 26566255Boody 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.
- Background: PubMed 16618333Zempsky 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.
- Background: PubMed 21554389Lazar 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.
- Background: PubMed 15799803Hall 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.
- Background: PubMed 27135641Asomugha 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.
- Background: PubMed 26500800Saeedinia 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edgar Santos-Marcial, P.D. Dr. med principal investigator
Diakonie Klinik Stuttgart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Site Infections and Lumbar Spinal Fusion, run by Diakonie-Klinikum Stuttgart at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical site infections (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06664424, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.