Clinical application of a custom-made simple subcutaneous negative pressure drainage device for the treatment of SSI after abdominal surgery: a randomized controlled trial.

BACKGROUND

The current gold standard for managing surgical site infections (SSIs) is the vacuum-assisted closure (VAC) technique, also known as vacuum sealing drainage (VSD). However, its high cost and technical complexity necessitate specialized health care personnel for proper application and monitoring, thereby limiting its widespread clinical adoption. Building on the theoretical framework and mechanistic principles of VSD systems, we developed a simplified subcutaneous negative pressure drainage device and conducted a preliminary evaluation of its clinical efficacy and potential for broader implementation.

OBJECTIVE

To evaluate the clinical efficacy of a novel, custom-designed simplified subcutaneous negative pressure drainage device for the treatment of SSIs following abdominal surgery.

METHODS

A total of 85 patients who were diagnosed with postoperative incisional infections following abdominal surgery between August 2022 and November 2024 were enrolled as study participants. These patients were randomly allocated using a computer-generated randomization sequence into either a standard care group or an intervention group. The standard care group received standard wound care, including conventional dressing changes, whereas the intervention group was treated with a custom-designed simplified subcutaneous negative pressure drainage device. The primary endpoint was wound healing status. The secondary endpoints included the wound healing time, frequency of dressing changes, cost of wound care, duration of antibiotic therapy, length of hospital stay, serum C-reactive protein (CRP) and interleukin-6 (IL-6) levels, and patient satisfaction scores.

RESULTS

Compared with the standard care group, the intervention group demonstrated superior wound healing outcomes ( P < 0.001). Furthermore, the intervention group demonstrated significantly shorter wound healing times, fewer dressing changes, lower wound care costs, a shorter duration of antibiotic use, and shorter hospital stays than did the standard care group (all P < 0.001). Posttreatment CRP and IL-6 levels were significantly lower in both groups ( P < 0.001). Patient satisfaction scores were also significantly higher in the intervention group than in the standard care group ( P < 0.001).

CONCLUSION

The custom-designed, simple subcutaneous negative pressure drainage device effectively improves the healing of infected wounds after abdominal surgery. It shortens the duration of antibiotic therapy and hospital stay while reducing overall treatment costs. This device demonstrates satisfactory therapeutic efficacy and holds strong potential for widespread clinical application and promotion.