Safety Study of HealiAid Collagen Wound Dressing in Adults Undergoing Breast Tumor Surgery

What this Trial Is About

Researchers are evaluating the safety of the HealiAid Collagen Wound Dressing in patients undergoing surgery for breast tumors, including both benign and malignant types with tumor sizes up to 5 cm. This open-label, multicenter, post-market clinical trial aims to record postoperative complications and adverse events, assess patient satisfaction and quality of life using the Breast-Q questionnaire, and monitor various health indicators such as vital signs, laboratory tests, tumor markers, breast ultrasonography, and mammography over a one-year period. During surgery, the tumor is completely removed with a 1-2 cm margin of healthy tissue, and the wound is cleaned before applying the HealiAid Collagen Wound Dressing. This soft, pliable dressing is adjusted to fit the wound size, using one to four pieces per wound, and remains in place until fully absorbed. Patients will follow standard postoperative rehabilitation protocols, including mobilization of the arm on the operated side shortly after surgery. Participants will be monitored closely during hospitalization for up to three days after surgery with continuous vital sign measurements. Follow-up visits occur at weeks 1, 2, 4, 12, 26, and 52 post-surgery, including wound assessments, adverse event monitoring, and breast appearance photographs at specified intervals. Breast ultrasonography is performed at weeks 2, 26, and 52, mammography at week 52, and laboratory tests including hematology and tumor marker assessments at week 26. Patient satisfaction and quality of life are evaluated before surgery and at multiple follow-up points using the Breast-Q questionnaire.

HealiAid Collagen Wound Dressing in Patients Undergoing Breast Tumor Surgery