Introducing DERMATAC™ Drape, the First-Ever FDA Cleared Silicone-Acrylic Hybrid NPWT Drape
KCI, an Acelity Company, today announced that the Company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for DERMATAC™ Drape, a proprietary silicone-acrylic hybrid drape that provides both clinical and operational benefits, as an accessory to certain of KCI’s Negative Pressure Wound Therapy (NPWT) Systems. Constructed with a precise combination of silicone and acrylic, DERMATAC™ Drape conforms to different anatomical locations, adapting to the body and providing a tight, highly-effective seal for 48 to 72 hours, including uneven areas, for wound protection, creating the ideal balance for wound healing support.
“We were able to re-engineer what was possible in design and chemistry to bring to life this new drape,” said R. Andrew Eckert, Chief Executive Officer, KCI. “The result is a remarkably effective therapeutic tool that is friendly to the skin and ensures a tight seal to protect wounds on all anatomical locations. It offers enhanced functionality relative to other drapes currently available, benefiting patients and healthcare providers alike.”
DERMATAC™ Drape offers healthcare providers the ability to place and reposition the drape during the initial dressing application, ensuring proper wound sealing and effectively overcoming challenges relative to traditional polyurethane drapes commonly used with NPWT by reducing product waste, minimizing risk to the peri-wound area and improving patient satisfaction due to little skin irritation and pain. Additionally, DERMATAC™ Drape could result in less training for clinicians due to ease of application, while also providing faster dressing changes compared to standard of care.
“The pressure of NPWT placements can be immense, and the process cumbersome and time-consuming for clinicians caring for very ill patients who often deal with excruciating pain during these periods, especially those with large and severe wounds,” said Ralph J. Napolitano, Jr., DPM, CWSP, FACFAS, OrthoNeuro, Columbus, Ohio. “The combination of benefits in DERMATAC™ Drape provides the necessary seal and protection with a near pain-free experience for the patient; moreover, the ability to easily reposition DERMATAC™ Drape saves the clinician significant time and reduces the amount of wasted drape. I’ve found that it certainly reduces anxiety for providers as dressing changes comprise the most time-consuming element in caring for wounds.”
“As the industry leader, we see a tremendous opportunity to advance the technology behind drapes and dressings for NPWT,” added Eckert. “If we provide clinicians with more options, then we expect that more people will have the opportunity to receive this differentiated therapy. By fulfilling our promise to deliver new technology to market, we can help physicians intervene sooner, ease the burden of therapy, and improve how patients heal all while reducing costs.”
KCI designed DERMATAC™ Drape to evolve the current standard of care with improved patient benefits in mind; however, additional operational advantages include the ability to reposition the drape during dressing changes that may result in a reduction of healthcare professional’s time and skill-level required to manage workflow of wound patients.
“In the home care setting, DERMATAC™ Drape holds promise for those patients receiving care for their chronic wounds as they struggle to maintain normalcy in their daily lives,” added Dr. Napolitano. The combination of silicone and acrylic and three-day wear time allows for patients to shower and ambulate while their wound remains protected and sealed, even in anatomically challenging areas. In addition, the skin-friendly benefits have the potential to have profound effects on patient satisfaction during dressing changes.”
KCI currently offers DERMATAC™ Drape in a Limited Commercial Release (LCR) in the US, and the early feedback from healthcare professionals and patients is largely positive. DERMATAC™ Drape will be more widely available to healthcare providers in the United States beginning in the summer of 2019.