Status:
RECRUITING
HealiAid Collagen Wound Dressing in Patients Undergoing Breast Tumor Surgery
Lead Sponsor:
Maxigen Biotech Inc.
Conditions:
Breast Tumors
Wound Healing
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to evaluate the safety of the collagen wound dressing (HealiAid) in breast tumor patients with surgical treatment. The main questions it aims to answer are: 1. To r...
Detailed Description
This study is an open label, multicenter post-market clinical follow-up study with a single arm group design. Included patients with confirmed diagnosis of breast tumor who are candidates for surgical...
Eligibility Criteria
Inclusion
- Age 18-70 years old.
- Patients are diagnosed with a benign or malignant breast tumor, that tumor size of ≦ 5 cm and no distant metastasis assessed by the imaging (breast ultrasonography, mammography, or MRI) and pathologic examination within 12 weeks before screening. If a benign breast tumor is identified through imaging and subsequently removed via surgery performed after the subject's enrollment in the study, the pathology report from that surgery should be used instead of any previous report.
- Patients diagnosed with a breast tumor, or those with a history of radiation and chemotherapy, who are scheduled to undergo surgery such as partial mastectomy, breast-conserving surgery, sentinel lymph node dissection, and/or axillary lymph node dissection .
- Patients who understand and are able to comply with follow-up visits and treatment during the trial period.
- Patients who are willing and capable of providing written informed consent. Not a person subject to a sentence of guardianship or subject to judicial guardians.
Exclusion
- Patients with breast cancer stage III or IV.
- Patients with inflammatory breast cancer.
- Patients with multicentric lesions or lesions with diffuse microcalcification.
- Patients with retro areolar breast carcinoma.
- Have a history of severe allergies or are allergic to collagen.
- Collagen vascular disease.
- History of serious postoperative complications.
- Infected wound.
- Patients who require emergency surgery.
- Patients with coagulation dysfunction, such as abnormal preoperative coagulation time (prothrombin time (PT)\>18 seconds or partial thromboplastin time (PTT) \>50 seconds)
- Patients with untreated or unstable diabetes, that the fasting blood sugar \>180 mg/dL or postprandial blood sugar \>200 mg/dL.
- Patients with untreated or unstable chronic diseases, such as hypertension, hyperlipidemia, cardiovascular disease, stroke.
- Patients with Body mass index (BMI) \> 30.
- Patients who are pregnant or breastfeeding women.
- Patients with drug abuse or addiction.
- Others who have been judged by the principal investigator as participating in this trial will endanger their physical and mental health.
Key Trial Info
Start Date :
May 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07209020
Start Date
May 20 2025
End Date
May 31 2027
Last Update
October 6 2025
Active Locations (3)
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1
Cardinal Tien Hospital
New Taipei City, Taiwan, Taiwan, 23148
2
Taipei Medical University Hospital
Taipei, Taiwan, Taiwan, 110301
3
Tri-Service General Hospital
Taipei, Taiwan, Taiwan, 114202