Actively Recruiting
HealiAid Collagen Wound Dressing in Patients Undergoing Breast Tumor Surgery
Led by Maxigen Biotech Inc. · Updated on 2025-10-06
60
Participants Needed
3
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 record the incidence of the postoperative complications and adverse events (AEs) after applying the HealiAid wound dressing in patients undergoing surgery for breast tumor. 2. To evaluate the patients' satisfaction and quality of life using the Breast Q questionnaire before surgery and at weeks 2, 12, 26, and 52 after the surgery. 3. To evaluate the patients' results of vital signs, hematology tests, tumor marker tests, breast ultrasonography, and mammography after the surgery. Participants will undergo a breast surgery. Within the surgery procedure, the tumor will be completely removed with a margin of 1-2 cm surrounding healthy tissue and the wounds will be cleaned properly before the patients receive the HealiAid Collagen Wound Dressing at treatment visit, and six follow up visits at week 1, 2, 4, 12, 26 and 52.
CONDITIONS
Official Title
HealiAid Collagen Wound Dressing in Patients Undergoing Breast Tumor Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-70 years old
- Diagnosed with a benign or malignant breast tumor measuring 5 cm or less with no distant metastasis as assessed by imaging and pathology within 12 weeks before screening
- Scheduled for surgical treatment such as partial mastectomy, breast conserving surgery, sentinel lymph node dissection, or axillary lymph node dissection
- Able to understand and comply with follow-up visits and treatment during the trial
- Willing and able to provide written informed consent and not under guardianship or judicial guardianship
You will not qualify if you...
- Breast cancer stage III or IV
- Inflammatory breast cancer
- Multicentric lesions or lesions with diffuse microcalcification
- Retroareolar breast carcinoma
- History of severe allergies or allergy to collagen
- Collagen vascular disease
- History of serious postoperative complications
- Infected wound
- Emergency surgery required
- Coagulation dysfunction with abnormal preoperative coagulation times
- Untreated or unstable diabetes with high fasting or postprandial blood sugar
- Untreated or unstable chronic diseases such as hypertension, hyperlipidemia, cardiovascular disease, or stroke
- Body mass index over 30
- Pregnancy or breastfeeding
- Drug abuse or addiction
- Any condition judged by the investigator to endanger physical or mental health during the trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Cardinal Tien Hospital
New Taipei City, Taiwan, Taiwan, 23148
Actively Recruiting
2
Taipei Medical University Hospital
Taipei, Taiwan, Taiwan, 110301
Actively Recruiting
3
Tri-Service General Hospital
Taipei, Taiwan, Taiwan, 114202
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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