FDAnews Device Daily Bulletin
Quality / Medical Devices / Research and Development / Commercial Operations

Smith & Nephew Trumpets Review Showing Fewer Complications With Negative Pressure Wound Therapy

Jan. 28, 2014

Smith & Nephew ballyhooed the results of a literature review showing fewer complications in wound healing in patients with closed surgical incisions who received negative pressure wound therapy three to five days post-op. The review, published in the UK journal Bone and Joint, relied on 33 publications: nine from orthopedic surgery, four from cardiothoracic surgery and 12 from abdominal, plastic and vascular fields, with 26 having been published in the last three years.

The authors acknowledge that there are gaps in understanding how NPWT works. “There are insufficient data yet to identify optimum levels of negative pressure,” they write. “Nevertheless, the availability of single-use NPWT devices means that costs of therapy are now such that exciting opportunities for building clinical evidence in large randomized studies are a prospect over the coming years.” A scientist at the company, which makes NPWT devices, co-authored the paper.

The authors are currently finishing independent investigator-initiated studies with Smith & Nephew’s single-use PICO negative wound pressure system, the company said. The system won FDA clearance in Jan. 2012 for use with chronic, acute and traumatic wounds, subacute and dehisced wounds, partial-thickness burns, diabetic or pressure ulcers, flaps and grafts and closed surgical incisions.

Robin Martin, director of clinical sciences at Smith & Nephew and a co-author of the literature review, said that the company is also planning to evaluate NPWT as a preventive technology in patients with greater risks of surgical site complications from orthopedic procedures. — Lena Freund

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.