HealiAid collagen wound dressing for people having breast tumor surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.