RecruitingNot ApplicableNCT07209020

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


Sponsor

Maxigen Biotech Inc.

Enrollment

60 participants

Start Date

May 20, 2025

Study Type

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a special collagen wound dressing called HealiAid after breast tumor surgery to see if it helps wounds heal faster and reduces complications compared to standard wound care. **You may be eligible if...** - You are 18–70 years old - You have been diagnosed with a benign or malignant breast tumor (5 cm or smaller) with no distant spread - You are scheduled for breast surgery such as lumpectomy, breast-conserving surgery, or lymph node removal - Your tumor has been confirmed by imaging or pathology **You may NOT be eligible if...** - Your tumor is larger than 5 cm - Your cancer has spread to distant organs - You have certain conditions that would interfere with wound healing - You are unable to follow up as required by the study protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHealiAid Collagen Wound Dressing

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)

Cardinal Tien Hospital

New Taipei City, Taiwan, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan, Taiwan

Tri-Service General Hospital

Taipei, Taiwan, Taiwan

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NCT07209020


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