As part of the process for FDA clearance of the PICO 7 and 14 sNPWT Systems, the clinical evidence was subject to rigorous review. Only the highest quality evidence was considered, such as randomized controlled trials (RCTs)
Smith+Nephew’s PICO Negative Pressure Wound Therapy Systems. (Credit: Smith & Nephew)
Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology business, is pleased to announce new indications for use for its PICO 7 and PICO 14 Single Use Negative Pressure Wound Therapy (sNPWT) Systems.
The U.S. Food and Drug Administration (FDA) cleared the systems for use on closed surgical incisions, to aid in reducing the incidence of:
Superficial and deep incisional surgical site infections (SSIs) for high risk patients in Class I and Class II wounds
Post-operative Seroma
Dehiscence
The development of post-operative surgical site complications (SSCs), such as surgical wound dehiscence, are a substantial burden for patients and healthcare systems, globally1. Postoperative wound dehiscence cases from the Nationwide Inpatient Sample demonstrate 9.6% excess mortality, 9.4 days of excess hospitalization and $40,323 in excess hospital charges relative to matched controls2.
In addition, it is estimated that 5% of all patients undergoing a surgical procedure will develop an SSI1. In the U.S. alone, more than 500,000 patients are affected by SSIs each year, resulting in about 8,000 deaths annually3. SSIs are also the most common reason for readmission to the hospital, accounting for 19.5% of overall readmissions4. However, 60% of all SSIs are considered preventable.
“As a high-volume elective hip and knee replacement surgeon, I am sending more patients home the same day with outpatient surgery,” said Dr. Bashyal, Director of Outpatient Total Joints, NorthShore University Health System, Chicago, Illinois. “The PICO System, has been a game changer in managing closed incisions in my practice by helping to reduce the incidence of wound complications including drainage, seromas, and superficial infections.”
As part of the process for FDA clearance of the PICO 7 and 14 sNPWT Systems, the clinical evidence was subject to rigorous review. Only the highest quality evidence was considered, such as randomized controlled trials (RCTs). Overall, twenty-five (25) studies enrolling 5,560 patients were included, spanning a variety of surgical specialties such as cesarean section, orthopedics and colorectal. By performing meta-analyses on these studies, the PICO 7 sNPWT System demonstrated statistical efficacy when compared to conventional dressings, including the reduction of the incidence of superficial and deep incisional SSIs for class I and class II wounds. The PICO System also reduced the odds of post-operative seroma and dehiscence.
Recently celebrating 10 years in clinical practice, PICO sNPWT has been used on an estimated 2.3 million surgical incisions; helping to prevent surgical site complications.1,5 The PICO System has helped reduce hospital stays and spared healthcare systems the associated costs of nursing time and resourcesⱡ1,6,7.
Additionally, the PICO 7Y System, which treats two wounds simultaneously, was also cleared by the FDA to aid in the reduction of the incidence of superficial incisional SSIs for high risk patients in Class I wounds, post-operative seroma and dehiscence. The PICO System is demonstrated to be effective for up to 7 days for aiding in reducing the incidence of surgical site infection.
Source: Company Press Release