An interventional study of HealiAid Collagen Wound Dressing in Breast Tumors, Wound Healing and Collagen Wound Dressing, sponsored by Maxigen Biotech Inc.. Recruiting at 3 sites in Taiwan. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-10-06.
Sponsored by Maxigen Biotech Inc. · Not applicable, Interventional, and Treatment
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:
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.
This study is an open label, multicenter post-market clinical follow-up study with a single arm group design. Included patients with confirmed diagnosis of breast tumor who are candidates for surgical treatment, including breast partial mastectomy (BPM), breast conserving surgery (BCS), sentinel lymph node dissection (SLND) and/or axillary lymph node dissection (ALND).
Within the surgery procedure, the tumor is completely removed with a margin of 1-2 cm around healthy tissue. Wounds are then 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.
The rehabilitation and the related introduction postoperative will follow the hospital protocols, patients will be advised to mobilize the ipsilateral arm within a few hours after surgery.
Patients will be visited at weeks 1, 2, 4, 12, 26, and 52 after surgery and assessed for surgical site wound and AE assessment. Additionally, photographs of the breast appearance are taken post-surgery before discharge and at weeks 12, and 52 after the surgery. Patient's quality of life (QoL) and satisfaction are evaluated using the Breast-Q questionnaire on screening day, before surgery on day 1, and at weeks 2, 12, 26, and 52 after the surgery.
Vital signs including respiratory rate, pulse, blood pressure and temperature will be continuously measured during the patients' hospitalization period following the surgery, which is estimated to last up to 3 days.
For the follow up examination, the breast ultrasonography will be performed at week 2 and 26 and week 52, and mammography will be performed at week 52. The hematology test and Tumor marker test will be performed at week 26.
All hypothesis tests are two-sided, use α=0.05, if P\<0.05, it is considered statistically significant. For inferential statistics, comparison of quantitative data, use the t-test or Wilcoxon rank sum test. For count data comparison, use Chi-square test or Fisher's exact test. For continuous data comparison, use repeated measured ANOVA test. For main/significant safety indicators, consider the influence of center or other stratification factors and perform Pearson correlation test (with baseline data as covariates).
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 60 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Maxigen Biotech Inc. is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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.
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.
Time frame: Day0 through out 52 weeks
Satisfaction and quality of life
To evaluate the patients' satisfaction and quality of life using the questionnaire: Breast Q Breast Conserving Therapy Module. Scores range from 0 to 100, with higher scores indicating better satisfaction and quality of life.
Time frame: before surgery and at weeks 2, 12, 26, and 52 after the surgery.
Number of participants with abnormal vital sign results
Number of participants who present with abnormal vital sign results. Vital signs include respiratory rate, pulse, blood pressure and temperature. The vital sign will be continuously measured post-surgery to discharge, which is estimated to last up to 3 days.
Time frame: From post-surgery until discharge, assessed up to 3 days.
Number of participants with abnormal laboratory tests results
Number of participants who present with abnormal hematology test result at Week 26. Hematology test including the data of white blood cell (WBC) count, red blood cell (RBC) count, hemoglobin (Hgb), hematocrit (Hct), platelet (PLT) count.
Time frame: Week 26 after the surgery.
Number of participants with abnormal tumor marker test results
Number of participants with abnormal tumor marker results for breast cancer including CA-153 and CEA.
Time frame: Week 26 after the surgery.
Breast ultrasonography
Breast ultrasonography may be postponed to Visit 4 (Week 4 ±7 days) if not feasible at Visit 3 (Week 2).
Time frame: Weeks 2, 26, and 52 after the surgery
Mammography
Mammography will be performed at week 52
Time frame: Week 52 after the surgery
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Maxigen Biotech Inc.