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Comparative study for effectiveness of MegaDerm Plus and Split-thickness skin graft on full thickness skin defect treatment : Multicenter, subject/independent-assessor blinded, randomized, superiority, investigator-initiated study.

Comparative study for effectiveness of MegaDerm Plus and Split-thickness skin graft on full thickness skin defect treatment : Multicenter, subject/independent-assessor blinded, randomized, superiority, investigator-initiated study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0007040
Enrollment
84
Registered
2022-02-24
Start date
2022-03-14
Completion date
Unknown
Last updated
2025-08-18

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 : In the control group, the dead tissues in the skin defect area are demarcated and a partial-layer skin graft is performed. In the study group, the dead tissues of the skin defect area

Sponsors

The Catholic University of Korea, Seoul St. Mary's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All subjects can participate in the clinical trial only when all of the following criteria are met. 1) Those aged 19 or over and under 70 years of age 2) After hearing and fully understanding the detailed explanation of this clinical trial, the subject or legal representative voluntarily decides to participate in the clinical trial and gives written consent 3) Patients in need of reconstruction due to a loss of the entire skin layer due to an accident or disease

Exclusion criteria

Exclusion criteria: If any of the following items apply, the subject is excluded from the clinical trial. 1) Pregnant, lactating women 2) Those who do not have diseases that generally affect wound healing or taking medications (immunosuppressive diseases, collagen metabolic diseases, systemic vasculitis, etc.) 3) A person with a history of surgery in the same area 4) drug and alcohol addicts 5) Those with infectious skin disease 6) Those with psychiatric problems 7) Other clinical trial investigators judged to be inappropriate

Design outcomes

Primary

MeasureTime frame
Functional evaluation of the skin (elasticity)

Secondary

MeasureTime frame
Functional evaluation of skin (moisture, transdermal moisture loss, melanin index, erythema index);Functional evaluation of skin (elasticity, moisture, transdermal moisture loss, melanin index, erythema index);Satisfaction Rating;Assessment of engraftment area ratio

Countries

Korea, Republic of

Contacts

Public ContactSuk-Ho Moon

The Catholic University of Korea, Seoul St. Mary's Hospital

nasuko@naver.com+82-2-2258-1316

Outcome results

None listed

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