HealiAid Collagen Wound Dressing in Patients Undergoing Breast Tumor Surgery

NCT07209020 | Recruiting

• 1 other identifier: MBI-HAS-202403
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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. 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. 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. 3.To evaluate the patients' results of vital signs, hematology tests, tumor marker tests, breast ultrasonography, and mammography after the surgery.

Conditions

Breast Tumors; Wound Healing; Collagen Wound Dressing

Keywords

breast tumors; wound healing; collagen wound dressing

Outcome Measures

Primary Outcomes (1)

• Incidence of the postoperative complications and adverse events

  The incidence of the postoperative complications and adverse events (AEs) using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 and to assess surgical site wounds after applying the HealiAid wound dressing in patients undergoing surgery for breast tumor.

  Day0 through out 52 weeks

Secondary Outcomes (6)

• Satisfaction and quality of life

  before surgery and at weeks 2, 12, 26, and 52 after the surgery.

• Number of participants with abnormal vital sign results

  From post-surgery until discharge, assessed up to 3 days.

• Number of participants with abnormal laboratory tests results

  Week 26 after the surgery.

• Number of participants with abnormal tumor marker test results

  Week 26 after the surgery.

• Breast ultrasonography

  Weeks 2, 26, and 52 after the surgery

Study Arms (1)

HAS

EXPERIMENTAL

Device: HealiAid Collagen Wound Dressing

Interventions

HealiAid Collagen Wound Dressing DEVICE

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.

HAS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maxigen Biotech Inc.: lead

Study Sites (3)

Cardinal Tien Hospital

New Taipei City, Taiwan, 23148, Taiwan

RECRUITING

Taipei Medical University Hospital

Taipei, Taiwan, 110301, Taiwan

RECRUITING

Tri-Service General Hospital

Taipei, Taiwan, 114202, Taiwan

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: October 6, 2025
• Study Start: May 20, 2025
• Primary Completion: October 31, 2025
• Study Completion (Estimated): May 31, 2027
• Last Updated: October 6, 2025

Record last verified: 2025-09

Locations

TW (3)