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A Prospective Study of Regenerative Peripheral Nerve Interface using Acellular Dermal Matrices after Mastectomy

A Prospective Study of Regenerative Peripheral Nerve Interface using Acellular Dermal Matrices after Mastectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009658
Enrollment
60
Registered
2024-07-30
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

None listed

Interventions

Procedure/Surgery : Subjects who meet the eligibility criteria will be allocated according to a randomization table. They are divided into a experimental group and a control group at a 1:1 probability

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Patients aged 20 years or older and under 80 years of age who undergo immediate breast reconstruction using implants after total mastectomy

Exclusion criteria

Exclusion criteria: 1) Those who have previously had mastectomy, breast augmentation, or breast reconstruction 2) Patients who have undergone organ transplant and are taking immunosuppressants 3) Those whose mental state may affect the progress of clinical trials due to alcohol and drug abuse 4) Those who are unable to conduct the survey conducted in this clinical trial 5) Other patients who are judged to be difficult to participate in this clinical trial by the investigator

Design outcomes

Primary

MeasureTime frame
Breast pain NRS score, MaGill questionnaire Evaluation comparison, Breast pain that lasts more than 3 months after surgery NRS pain of 3 or more, breast q score

Secondary

MeasureTime frame
Drainage volume, Infection, Breast skin blood flow disorder, Seroma, Hematoma, Implant removal, Reoperation

Countries

Korea, Republic of

Contacts

Public ContactHyun Ho Han

Asan Medical Center

tripleh1952@gmail.com+82-2-3010-3601

Outcome results

None listed

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