The evaluation of the anti-adhesive effect of Guardix-sol. for the prevention of arm and shoulder morbidity after total mastectomy

The clinical efficacy of Guardix-sol. for the prevention of arm and shoulder morbidity after total mastectomy

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0000003

Enrollment

100

Registered

2010-06-09

Start date

2009-07-13

Completion date

Unknown

Last updated

2019-03-11

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 : Patients who were enrolled in this study were randomized to either the Guardix group or the no-treatment control group after completion of the main portion of the operation and just b

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: All patients are required to be scheduled for a total mastectomy with or without surgery for axillary nodal staging (axillary lymph nodes dissection or sentinel lymph node biopsy) for their breast cancer.

Exclusion criteria

Exclusion criteria: Patients who had impaired arm and shoulder motor function, or who had a previous breast surgery for ipsilateral breast. Patients with multiple primary cancers, stage IV breast cancer, or recurrent breast cancer.

Design outcomes

Primary

Measure	Time frame
Active range of motion of shoulder	—

Secondary

Measure	Time frame
Pectoralis minor length test;Daily activity;Disabilities of Arm, Shoulder and Hand (DASH), Korean version	—

Countries

Korea, Republic of

Contacts

Public ContactEunyoung Kang

Seoul National University Bundang Hospital

Outcome results