An integrated, wearable, tubeless micro-negative pressure system for closed incision management: a translational preclinical and clinical study.

Background/objectives: Closed incision management remains a challenge in postoperative care, largely due to the difficulty of maintaining a stable wound microenvironment in routine clinical practice. Although negative pressure therapy has demonstrated clinical benefits, its real-world effectiveness is often limited by device-related constraints. This study aimed to develop a fully wearable, integrated, tubeless micro-negative pressure system and evaluate its therapeutic potential. Methods: The system was designed and evaluated in rabbit closed-incision models. Wound exudate control, bacterial burden, inflammatory response, and tissue repair were systematically assessed. In addition, a preliminary clinical study was conducted in patients undergoing minimally invasive spinal surgery to evaluate feasibility, safety, and postoperative performance. Results: The device significantly reduced exudate accumulation and bacterial burden, and promoted a shift toward a pro-regenerative inflammatory profile. Enhanced tissue repair was observed, including increased angiogenesis, cell proliferation, and collagen deposition. These beneficial effects were consistent across experimental models. In clinical application, the system demonstrated effective exudate management, good usability, and favorable postoperative performance. Conclusion: This wearable, integrated, tubeless micro-negative pressure system provides an effective and clinically feasible strategy for closed incision management. Its ability to regulate the wound microenvironment and promote tissue repair highlights its translational potential as an alternative to conventional negative pressure therapy.