Breast TumorsNCT07209020
HealiAid Collagen Wound Dressing in Patients Undergoing Breast Tumor Surgery
A study testing HealiAid Collagen Wound Dressing in people with Breast Tumors and Wound Healing, run by Maxigen Biotech Inc. at 3 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Tumors, Wound Healing, Collagen Wound Dressing
- What is being tested?
- HealiAid Collagen Wound Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesTaiwan
- Study dates
- 20 May 2025to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan3 sites, 3 recruiting
- Recruiting
Cardinal Tien Hospital
New Taipei City, Taiwan, 23148
Attending Physician, +886952655107, corn110006@gmail.com
- Recruiting
Taipei Medical University Hospital
Taipei, Taiwan, 110301
Attending Physician, +886970405127, hungcs@tmu.edu.tw
- Recruiting
Tri-Service General Hospital
Taipei, Taiwan, 114202
Attending Physician, +886287923311 ext. 12705, liaogs20371@gmail.com
About this study
Official title: Safety Observation of HealiAid Collagen Wound Dressing in Patients Undergoing Breast Tumor Surgery: A Post-Market Clinical Trial
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:
- 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.
- 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.
- 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.
Read the detailed description
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).
- Conditions
- Breast Tumors, Wound Healing, Collagen Wound Dressing
- Being tested
- HealiAid Collagen Wound Dressing
- Keywords
- breast tumors, wound healing, collagen wound dressing
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealiAid Collagen Wound DressingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| HAS | Experimental | Not described Receives: Device: HealiAid Collagen Wound Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day0 through out 52 weeks
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Weeks 2, 26, and 52 after the surgery
Mammography
Mammography will be performed at week 52
Measured: Week 52 after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start20 May 2025
- Primary completion31 Oct 2025 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maxigen Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209020
- Sponsor's protocol ID
- MBI-HAS-202403
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Observation of HealiAid Collagen Wound Dressing in Patients Undergoing Breast Tumor Surgery: A Post-Market Clinical Trial
- ClinicalTrials.gov ID
- NCT07209020
- Acronym / sponsor ID
- MBI-HAS-202403
- Conditions
- Breast Tumors, Wound Healing, Collagen Wound Dressing
- Keywords
- breast tumors, wound healing, collagen wound dressing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Maxigen Biotech Inc.Industry (pharma, biotech, devices)
- Study start
- 20 May 2025 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAS | Experimental | Device: HealiAid Collagen Wound Dressing |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HealiAid Collagen Wound DressingWithin 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. | Device | HAS |
Primary outcome
Incidence of the postoperative complications and adverse events
Time frame: Day0 through out 52 weeks
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.
6 secondary outcomes
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
Time frame: From post-surgery until discharge, assessed up to 3 days.
Number of participants with abnormal laboratory tests results
Time frame: Week 26 after the surgery.
Number of participants with abnormal tumor marker test results
Time frame: Week 26 after the surgery.
Breast ultrasonography
Time frame: Weeks 2, 26, and 52 after the surgery
Mammography
Time frame: Week 52 after the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HealiAid Collagen Wound Dressing in people with Breast Tumors and Wound Healing, run by Maxigen Biotech Inc. at 3 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of the postoperative complications and adverse events (time frame: Day0 through out 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.