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Comparison of efficacy and safety between Xkin Closure versus Stapler for surgical wound suture

Comparison of efficacy and safety between Xkin Closure versus stapler for surgical wound suture: A randomized control, single-center, open-label trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008685
Enrollment
50
Registered
2023-08-04
Start date
2022-11-14
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

None listed

Interventions

Medical Device : Number of set: Use at least one set. The number of sets can be additionally used by the operator if necessary. How to use: When suturing the main wound, open the assigned suture set

Sponsors

Seoul National University Bundang Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: A. A patient undergoing robot-assisted laparoscopic radical prostatectomy for prostate cancer B. Patients whose prostate size measured before surgery is less than 60cc C. Patients able to read informed consent and voluntarily consent D. Adults over 19 years of age

Exclusion criteria

Exclusion criteria: A. Patients who are not suitable for participation in clinical trials due to comorbidities such as moderate to severe cardiovascular disease, cerebrovascular disease, respiratory or liver disease B. Uncontrolled Infectious Disease C. Uncontrolled hemorrhagic tendencies D. If it is impossible to stop taking steroids or immunosuppressants for up to 12 weeks from surgery E. Those who are judged by the investigator to be inappropriate to participate in other clinical trials

Design outcomes

Primary

MeasureTime frame
Vancouver Scar Scale(VSS), Scar height by 3D camera

Secondary

MeasureTime frame
sutured site healing, local adverse events and infection

Countries

Korea, Republic of

Contacts

Public ContactJihee Jeong

Seoul National University Bundang Hospital

phobiamumu@naver.com+82-31-787-6724

Outcome results

None listed

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