The Efficacy of SurgiGuard in prevention of seroma formation after total mastectomy

The Efficacy of SurgiGuard in prevention of seroma formation after total mastectomy; A prospective randomized trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005637

Enrollment

100

Registered

2020-11-27

Start date

2019-06-01

Completion date

Unknown

Last updated

2020-12-02

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

Conditions

None listed

Interventions

Drug : Surgiguard(Samyang Biopharmaceuticals Corp., Seoul, Korea, 10cmx10cm, 1 sheet) is inserted to dead space after mastectomy before wound suture. Surgiguard should not to be removed. Additional ap

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Patients scheduled to undergo total mastectomy and node surgery (axillary lymph node dissection or sentinel lymph node biopsy) who were diagnosed with invasive breast cancer. 2) Patients who understand the goal and the process of the trial and who want to participate in the trial with written informed consent. 3) No age limitation.

Exclusion criteria

Exclusion criteria: 1) Patients who had a personal history of hypersensitivity or allergic reaction to anticoagulants 2) Patients with obesity (defined as a body mass index >30 kg/m2) 3) Patients who received neoadjuvant chemotherapy or planned to undergo immediate breast reconstruction 4) Patients who have plan to palliative surgery

Design outcomes

Primary

Measure	Time frame
daily seroma amount until discharge	—

Secondary

Measure	Time frame
total seroma amount	—

Countries

Korea, Republic of

Contacts

Public ContactYunyeong Kim

Gachon University Gil Medical Center

Outcome results