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HealiAid Collagen Wound Dressing in Patients Undergoing Breast Tumor Surgery

NCT07209020 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-10-06

No results posted yet for this study

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.

Conditions

  • Breast Tumors
  • Wound Healing
  • Collagen Wound Dressing

Interventions

DEVICE

HealiAid 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.

Sponsors & Collaborators

  • Maxigen Biotech Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-20
Primary Completion
2025-10-31
Completion
2027-05-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07209020 on ClinicalTrials.gov