HealiAid collagen wound dressing for people having breast tumor surgery
Safety Observation of HealiAid Collagen Wound Dressing in Patients Undergoing Breast Tumor Surgery: A Post-Market Clinical Trial
This will test a collagen wound dressing called HealiAid to see if it is safe and well tolerated in people having surgery to remove breast tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Maxigen Biotech Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (New Taipei City, Taiwan and 2 other locations) |
| Trial ID | NCT07209020 on ClinicalTrials.gov |
What this trial studies
This is an open-label, single-arm, multicenter post-market follow-up enrolling adults undergoing breast-conserving or related breast tumor surgeries. During the operation the tumor is removed with a 1–2 cm margin, the wound is cleaned, and the HealiAid collagen dressing is applied and left to be absorbed. Participants attend visits at weeks 1, 2, 4, 12, 26, and 52 for wound checks, adverse event monitoring, vital signs, laboratory tests, imaging, standardized photographs, and Breast-Q quality-of-life surveys. The study records postoperative complications, device-related adverse events, patient satisfaction, and clinical and imaging outcomes over one year.
Who should consider this trial
Good fit: Adults 18–70 with benign or malignant breast tumors ≤5 cm without distant metastasis who are scheduled for partial mastectomy, breast-conserving surgery, or lymph node procedures and can comply with follow-up are ideal candidates.
Not a fit: Patients with tumors larger than 5 cm or known distant metastases, those unable to undergo surgery or attend follow-up visits, or those with known hypersensitivity to collagen may not receive benefit from this dressing.
Why it matters
Potential benefit: If successful, the dressing could reduce postoperative wound complications and improve comfort and cosmetic outcomes after breast tumor surgery.
How similar studies have performed: Collagen wound dressings have demonstrated benefit for healing in other surgical and chronic wounds, though specific evidence in breast tumor surgery is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
New Taipei City, Taiwan and 2 other locations
- Cardinal Tien Hospital — New Taipei City, Taiwan, Taiwan (Recruiting)
- Taipei Medical University Hospital — Taipei, Taiwan, Taiwan (Recruiting)
- Tri-Service General Hospital — Taipei, Taiwan, Taiwan (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.