Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT07209020
Status:
RECRUITING
Last Update Posted:
2025-10-06
First Post:
2025-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HealiAid Collagen Wound Dressing in Patients Undergoing Breast Tumor Surgery
Sponsor:
Maxigen Biotech Inc.
Organization:
Study Overview
Official Title:
Safety Observation of HealiAid Collagen Wound Dressing in Patients Undergoing Breast Tumor Surgery: A Post-Market Clinical Trial
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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. 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.
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.
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).
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: