Actively Recruiting
Safety Observation of HealiAid Collagen Wound Dressing in Patients Undergoing Breast Tumor Surgery: A Post-Market Clinical Trial
Led by Maxigen Biotech Inc. · Updated on 2025-10-06
60
Participants Needed
3
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of the HealiAid Collagen Wound Dressing in patients undergoing surgery for breast tumors, including both benign and malignant types with tumor sizes up to 5 cm. This open-label, multicenter, post-market clinical trial aims to record postoperative complications and adverse events, assess patient satisfaction and quality of life using the Breast-Q questionnaire, and monitor various health indicators such as vital signs, laboratory tests, tumor markers, breast ultrasonography, and mammography over a one-year period. During surgery, the tumor is completely removed with a 1-2 cm margin of healthy tissue, and the wound is cleaned before applying the HealiAid Collagen Wound Dressing. This soft, pliable dressing is adjusted to fit the wound size, using one to four pieces per wound, and remains in place until fully absorbed. Patients will follow standard postoperative rehabilitation protocols, including mobilization of the arm on the operated side shortly after surgery. Participants will be monitored closely during hospitalization for up to three days after surgery with continuous vital sign measurements. Follow-up visits occur at weeks 1, 2, 4, 12, 26, and 52 post-surgery, including wound assessments, adverse event monitoring, and breast appearance photographs at specified intervals. Breast ultrasonography is performed at weeks 2, 26, and 52, mammography at week 52, and laboratory tests including hematology and tumor marker assessments at week 26. Patient satisfaction and quality of life are evaluated before surgery and at multiple follow-up points using the Breast-Q questionnaire.
CONDITIONS
Brief 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 benign or malignant breast tumor with tumor size 5 cm or smaller and no distant metastasis confirmed by imaging or pathology within 12 weeks before screening
- Scheduled for surgery including 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 capable of providing 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
- Retro areolar breast carcinoma
- History of severe allergies or allergy to collagen
- Collagen vascular disease
- History of serious postoperative complications
- Infected wound
- Need for emergency surgery
- 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 greater than 30
- Pregnant or breastfeeding women
- Drug abuse or addiction
- Other conditions judged by the principal investigator to endanger physical or mental health
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 days
Participants undergo breast tumor surgery including tumor removal and application of the HealiAid Collagen Wound Dressing. Vital signs are continuously monitored during hospitalization, which lasts up to 3 days after surgery.
Hospitalization period with continuous monitoring
Duration - 52 weeks
Participants are assessed for surgical site wound healing, adverse events, quality of life, and satisfaction. Follow-up includes breast ultrasonography and mammography as well as laboratory and tumor marker tests.
Visits at weeks 1, 2, 4, 12, 26, and 52 after surgery
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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