As the life expectancy of women with breast cancer is prolonged, there is a need to improve their quality of life (QOL) during or after breast cancer treatment. Adverse effects that mainly occur after breast cancer surgery include pain in the arms, sensory changes, muscle weakness, lymphatic edema, restricted shoulder mobility, and decreased function. Limitation of shoulder range of motion (ROM) and muscle weakness reduce activities of daily living and negatively affect QOL. A less invasive surgical procedure and a more selective treatment were used, but upper extremity dysfunction remains a serious complication after treatment . The efforts to reduce the complications of axillary lymph node dissection (ALND) are particularly necessary. In their prospective study, Kootstra et al. reported that the rate of complications including lymphatic edema, limitations on upper extremity mobility and shoulder ROM, and muscle weakness was significantly lower in the sentinel lymph node biopsy group than in the ALND group. Patients who underwent mastectomy had more reduced shoulder ROM and a higher frequency of pectoralis tightness than those who underwent breast-conserving surgery. Moreover, postoperative radiotherapy and the postoperative period are important factors. In addition, shoulder ROM was most reduced within 12 months after surgery and better thereafter. Upper extremity functions are essential in maintaining general QOL, particularly in maintaining independent living and performing tasks that require physical strength. Therefore, physical, mental, and social burdens may increase if the upper extremity functions decrease. Chronic upper extremity dysfunction is a long-term complication that occurs after breast cancer surgery, which considerably affects QOL and the performance of routine activities. 
Adhesion at the surgical site after ALND is a major cause of decreased shoulder ROM, pectoralis tightness, and pain. Therefore, we expect a significant reduction in these symptoms through effective anti-adhesion methods, which include minimization of intraoperative resection, use of anti-inflammatory drugs, and stimulation of plasminogen activator to prevent fibrin formation. 
In recent years, methods that use physical barriers have been employed. Materials used for the physical barriers include oxidized regenerated cellulose from natural polysaccharides, sodium carboxymethyl cellulose, dextran, and sodium hyaluronate. Further, synthetic polymers such as polyethylene glycol and poloxamer are used.
Guardix-SG® (Hanmi Pharmaceutical Co.,Ltd., Seoul, Korea) is an anti-adhesion agent consisting of poloxamer and sodium alginate. It prevents adhesion by forming a physical barrier on the surface of the wound tissue.
In this pilot study, patients undergoing modified radical mastectomy or breast-conserving surgery were followed up for 12 months after ALND surgery. The purpose of this study was to evaluate the effect of Guardix-SG® on shoulder ROM and its safety after breast cancer surgery.

 Supportive Care

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 underwent axillary lymph node dissection.

Arm Label

Target Number of Participant

Arm Type

Arm Description

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 underwent axillary lymph node dissection.

Arm Label

Target Number of Participant

Arm Type

Arm Description

Treatment of Breast Cancer Patients who underwent modified radical mastectomy or breast conserving surgery underwent surgery for axillary lymph node dissection.
Active controls are not used for control equipment.

Gender

Age

Description

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)

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

shoulder ROM(range of motion)

at baseline and at 3, 6, and 12 months

Laboratory test-WBC, Neubrophil

Laboratory test -WBS, Neubrophil before surgery, 7 days after surgery

draunge after surgery

drainage after surgery

Adverse Event, expected side effects

7 days after surgery, 3, 6, 12, months after surgery,  immediately after surgery

DASH(disavility of the arm, shoulder and hand)

at baseline and at 3, 6, and 12 months

VAS(visual analogue scale)

at baseline and at 3, 6, and 12 months

lymphatic edema assessed using body composition analysis

at baseline and at 3, 6, and 12 months