New collagen dressing aims to improve healing after breast tumor surgery
NCT ID NCT07209020
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is checking if a special collagen wound dressing called HealiAid is safe for people who have had breast tumor surgery. About 60 adults aged 18-70 with small breast tumors (benign or malignant) will receive the dressing right after their tumor is removed. Researchers will watch for complications, side effects, and how satisfied patients are with their recovery over one year.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cardinal Tien Hospital
RECRUITINGNew Taipei City, Taiwan, 23148, Taiwan
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Taipei Medical University Hospital
RECRUITINGTaipei, Taiwan, 110301, Taiwan
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Tri-Service General Hospital
RECRUITINGTaipei, Taiwan, 114202, Taiwan
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