Skip to content

A study to determine whether individually packaged implants reduce the risk of surgical site infections in spinal fusion surgery

The preventive effect of surgical site infection of individual packing and sterilization processing of implantation instruments for spinal fixation surgery: A Prospective, Randomized, Single-Blind Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010165
Enrollment
664
Registered
2025-02-04
Start date
2025-05-30
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

None listed

Interventions

Others : Spinal fixation surgery will be performed according to standard treatment protocols, along with routine evaluations and tests. During this process, informed consent will be obtained from pati

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Adults aged 19 years or older (2) Patients diagnosed with primary or metastatic spinal tumors, degenerative diseases, spinal deformities, inflammatory diseases, or trauma (3) Patients who have undergone spinal fixation surgery with the use of implants for one or more spinal segments due to compression of neural structures or spinal instability caused by the aforementioned diagnoses (4) Patients willing to participate in the study, adhere to treatment and procedures, and attend all follow-up evaluations (5) Patients who have voluntarily signed a written informed consent form after receiving an explanation of the study's purpose, methods, and potential effects

Exclusion criteria

Exclusion criteria: (1) Patients under 18 years old (2) Patients who, in the researcher's judgment, have significant cardiovascular, pulmonary, hepatic, or renal conditions that make spinal surgery under general anesthesia impossible (3) Patients with impaired cognitive function who are unable to communicate effectively with medical staff

Design outcomes

Primary

MeasureTime frame
Postoperative Surgical Site Infection (SSI) occurrence

Secondary

MeasureTime frame
Evaluation of implant alignment, subsidence, and other factors

Countries

Korea, Republic of

Contacts

Public ContactDanbi Park

Asan Medical Center

danbi08@kakao.com+82-2-2045-3829

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Apr 4, 2026