Single center, randomized, prospective, comparative study to evaluate the efficacy and safety according to type of acellular dermal matrix when being applied for reconstruction of defect areas after breast conserving surgery in breast cancer patients

Single center, randomized, prospective, comparative study to evaluate the efficacy and safety according to type of ADM(acellular dermal matrix) when being applied for reconstruction of defect areas after breast conserving surgery in breast cancer patients

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0008087

Enrollment

200

Registered

2023-01-06

Start date

2023-04-11

Completion date

Unknown

Last updated

2024-03-04

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 order to reconstruct the defect that occurred after breast conserving surgery, the study group inserts a diced type acellular dermis matrix wrapped in a gentamicin collagen sponge.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: All subjects can participate in the clinical trial only when all of the following criteria are met. ? Those aged over 20 years old and up to 70 years old ? Patients with histopathologically confirmed breast cancer ? The patients planning to undergo breast conserving surgery with MegaDerm(diced type or sheet type) where being applied for reconstruction of defect areas

Exclusion criteria

Exclusion criteria: If any of the following items apply, the subject is excluded from the clinical trial. ? In case of mastectomy additionally because of local recurrent after breast conserving surgery ? Who underwent total mastectomy ? Uncontrolled severe infection ? Autoimmune disease ? Coagulation disorder (it is possible be enrolled, if the patients take the Aspirin or Plavix) ? Other patients who were judged to be difficult to participate in this study by the investigator

Design outcomes

Primary

Measure	Time frame
aesthetic outcome evaluation	—

Secondary

Measure	Time frame
patients satisfaction evaluation;capsular contracture evaluation;complication evaluation	—

Countries

Korea, Republic of

Contacts

Public ContactKim Min Jeong

Inje University Busan Paik Hospital

minjeong.kim0926@gmail.com+82-51-890-5719

Outcome results