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Pilot study to evaluate the efficacy and safety of MegaNuovo in Pressure sore patients : single center, comparative, investigator-initiated pilot study

Pilot study to evaluate the efficacy and safety of MegaNuovo in Pressure sore patients : single center, comparative, investigator-initiated pilot study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0006745
Enrollment
30
Registered
2021-11-11
Start date
2020-01-17
Completion date
Unknown
Last updated
2021-12-02

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 : For the study group, MegaNuovo is applied after debridement, the control group 1 is performed to negative pressure treatment after the debridement, and the control group 2 is combinat

Sponsors

Yonsei University, Wonju Severance Christian Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Patients aged 19 to less than 90 years of age ? Patients with stage 2~4 pressure ulcers ? Patients who have fully explained the purpose and contents of the test before taking the test and voluntarily signed the written consent (a legal representative can represent him if necessary) ? Patients who can follow-up during the test period

Exclusion criteria

Exclusion criteria: ? HbA1c=12% ? Patients with evidence of active infection including osteomyelitis or cellulitis ? Patients who want surgical treatment ? Pregnant and lactating women (urine hCG test) ? Patients with psychiatric problems ? Patients with infectious diseases, systemic autoimmune diseases (rheumatic diseases, etc.), blood clotting disorders (diagnosed by medical staff through questionnaire and physical examination) ? In case it is judged difficult to conduct clinical trials by the principal investigator

Design outcomes

Primary

MeasureTime frame
The rate of change in the size of the ulcer at 4 weeks by group

Secondary

MeasureTime frame
The stage of the ulcer ;rate of infection;laboratory test;Proportion of patients with complete healing;The rate of change in the size of the ulcer

Countries

Korea, Republic of

Contacts

Public ContactChae-Eun Yang

Yonsei University Wonju College of Medicine

cheniya@yuhs.ac+82-33-730-1313

Outcome results

None listed

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