HealiAid Collagen Wound Dressing in Patients Undergoing Breast Tumor Surgery
Safety Observation of HealiAid Collagen Wound Dressing in Patients Undergoing Breast Tumor Surgery: A Post-Market Clinical Trial
Maxigen Biotech Inc.
60 participants
May 20, 2025
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria5
- 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 Criteria16
- 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.
Interventions
Within the surgery procedure, the tumor is completely removed and the wounds are cleaned properly before applying the HealiAid Collagen Wound Dressing. HealiAid is soft and pliable. It can be adjusted to the size of the wound, and it is recommended to apply one to four pieces per wound. HealiAid Collagen Wound Dressing will be kept in place until absorbed completely.
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT07209020