A prospective study to evaluate the effect of an anti-adhesion agent (Guardix-SG) on the range of shoulder motion after breast cancer resection

The Effects of Poloxamer and Sodium Alginate Mixture (Guardix-SG®) on Range of Motion after Axillary Lymph Node Dissection: A single-center, prospective, randomized, controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0003386

Enrollment

192

Registered

2018-12-07

Start date

2016-01-05

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 : As a standard procedure for the treatment of breast cancer, 5ml is applied to patients who underwent modified radical mastectomy or breast conserving surgery among patients who underw

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Adults over 20 years old 2. Patients diagnosed with breast cancer 3. Patients with breast cancer who underwent modified radical mastectomy or breast conserving surgery and performed axillary lymph node dissection (Including patients who underwent preoperative chemotherapy and those who underwent axillary lymph node dissection during surgery)

Exclusion criteria

Exclusion criteria: 1. Stage 0 2. Stage IV 3. Patients undergoing sentinel node biopsy alone 4. Reconstruction Patient 5. Pre-operative other shoulder disease with shoulder disability 6. Previous history of ipsilateral breast or axilla 7. Patients who are pregnant or lactating

Design outcomes

Primary

Measure	Time frame
shoulder ROM(range of motion);Laboratory test-WBC, Neubrophil;draunge after surgery;Adverse Event, expected side effects	—

Secondary

Measure	Time frame
DASH(disavility of the arm, shoulder and hand);VAS(visual analogue scale);lymphatic edema assessed using body composition analysis	—

Countries

Korea, Republic of

Contacts

Public ContactByung Ho Son

Asan Medical Center

brdrson@korea.com+82-2-3010-3927

Outcome results