Evaluation of an innovative new device for wound healing

Clinical trials are a way to study new products for safety/effectiveness(1). Ongoing research on new devices is essential to advance wound care.

We evaluated an innovative new device on aspects important to patients and providers in wound healing.  Our study consisted of three components: clinical trial, retrospective chart review and survey’s. After receiving IRB approval, 15 enrolled patients received 57 separate procedures.

This non-randomized, unblinded trial involved placement of a novel fluid delivery system instilling either small amounts of 3% gentamicin solution, sterile water, or normal saline at a constant rate to partially saturate a semi-occlusive pad. The dressing was applied to the wound and the activated device left in place for up to 5 days. A survey was completed at each visit by the provider analyzing application, removal, and device functioning. Patient question’s included the ability to perform ADL’s. A retrospective chart review showed data on wound progression before/after the device administration.

Safety:  No adverse events were reported during the study and no incidents between clinic visits; varying degrees of maceration of the periwound affected wound healing in 11% of the cases.

Ease of Use: Application time decreased to as little as 10 minutes; the device was deemed “intuitive”.  Removal of the device received 89% of clinicians rating as “easy‟.

Impact on ADL’s: 91% of patients responded that the device posed no limitations on their ADL’s; 4% even stated that it enhanced their daily activities.

Healing rates: determined to be favorable with 85% of the device applications resulting in wound healing rated “as anticipated” or “better than anticipated”; 14 out of 15 patients (93%) had a reduction in wound surface area.

Conclusion: Ease of use with favorable patient acceptance and possible improved healing rates suggests this device may have an application in wound care.