Prospective, randomized, subject single-blind, double-arm study to evaluate the outcome of ADM without basement membrane in prosthetic breast reconstruction

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0005852

Enrollment

Registered

2021-02-03

Start date

2021-02-01

Completion date

Unknown

Last updated

2021-02-23

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 : Among patients scheduled for total mastectomy, patients who visited the outpatient clinic and decided to undergo implant-based breast reconstruction, who wish to participate in thi

s Megaderm®, which has been approved by the Korean Food and Drug Administration and is commercially available. Number of test subjects: 30 people each for Arm I and Arm II, and a total of 60 people a

s Velazel, and the shape of the surface is the currently commercially available smooth or smooth fine implant. After surgery, a drainage tube is inserted before suturing. In order to confirm the pos

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Breast cancer patients aged 20 years or older and under 80 years of age who undergo breast reconstruction immediately after total mastectomy

Exclusion criteria

Exclusion criteria: 1) Those who have previously had mastectomy, breast augmentation, or breast reconstruction 2) When both breasts are performed at the same time or when the opposite side is performed 3) When inserting an expander 4) Patients who have undergone organ transplant and are taking immunosuppressants 5) Those whose mental state may affect the progress of clinical trials due to alcohol and drug abuse 6) Those who are unable to conduct the survey conducted in this clinical trial 7) Those who participated in other clinical trials within 120 days before screening 8) When other investigators determine that it is inappropriate for this clinical trial

Design outcomes

Primary

Measure	Time frame
Postoperative chemotherapy and radiation therapy	—

Secondary

Measure	Time frame
Vital sign (Blood pressure, pulse, body temperature);Adverse effect(Previous abdominal resection, augmentation, reconstruction, dilator insertion, organ transplantation, taking immunosuppressants, alcohol and drug abuse, etc.);Breast reconstruction surgery;Evaluate the progress of surgery and the presence of complications	—

Countries

Korea, Republic of

Contacts

Public ContactHyun Han

Asan Medical Center

Outcome results