HealiAid Collagen Wound Dressing in Patients Undergoing Breast Tumor Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMaxigen Biotech Inc.
About this 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:
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
HealiAid Collagen Wound Dressing
DeviceWithin 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: HASExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Day0 through out 52 weeksSecondary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov