Expanding the Boundaries of NPWT: Clinical Evidence and Off-Label Innovation
At the 2025 SAWC Spring meeting, Elizabeth Faust, MSN, MBA, ANP-BC, and Randy Peterson, DNP, APRN, CNP, A-GNP-C, CWCN, led a forward-looking session titled “NPWT: New Indications” that examined how negative pressure wound therapy (NPWT) continues to evolve through expanded indications and thoughtful off-label application. The speakers offered a deep dive into clinical evidence, regulatory considerations, and real-world adaptations that are redefining NPWT’s role across the continuum of wound care.
Navigating Indications: From Regulatory Approval to Clinical Judgment
Faust opened the session with a breakdown of the FDA clearance pathway, emphasizing the necessity of proving substantial equivalence to existing devices through rigorous safety and efficacy testing. Once cleared, indications for use are tightly defined, and applying NPWT outside those parameters, such as on infected wounds or over exposed bowel, moves into off-label territory.
She cautioned that while off-label use is common in wound care, it requires documentation, patient engagement, and a clear understanding of risks. “They really care about the safe and effective use of a device,” Faust said. “If you're using it off-label, you must understand what the literature supports and what the device was not designed to do.”
Off-Label in Action: Managing Exposed Bowel with NPWT
To illustrate thoughtful off-label application, Faust shared a case involving a 62-year-old female with a history of multiple abdominal surgeries who presented with an open abdomen and exposed bowel following a temporizing laparotomy. While NPWT is not approved for direct use over enteric structures, the team used a protective mesh over the bowel, layered with open-cell foam, and applied negative pressure to manage exudate and promote granulation.
“We had to piece together the dressing to do what was best for the patient,” Faust explained. “By adapting the dressing to her anatomy and using the technology cautiously, we saw robust granulation tissue over the bowel and ultimately achieved closure.”
This case demonstrated that, with proper protection and clinical oversight, NPWT can be successfully used in scenarios traditionally considered contraindicated. The patient avoided infection, maintained bowel integrity, and progressed to healing, highlighting the value of off-label innovation when guided by experience and evidence.
Addressing Bioburden: Instillation Therapy in Complex Wounds
Peterson introduced the audience to NPWT with instillation and dwell time (NPWTi-d), a modality designed to tackle persistent bioburden. In one example, a wound fluoresced significantly under bacterial imaging even after negative pressure therapy, indicating high bacterial load in the foam. “We have to rethink frequency of dressing changes and when to incorporate instillation,” he emphasized.
This advanced technique has been particularly useful in managing infected wounds where traditional NPWT alone may fall short. The ability to deliver antiseptic solutions directly into the wound bed improves cleansing and supports faster tissue recovery.
Extending NPWT into the Surgical Realm
A promising new direction for NPWT is its use over closed incisions with extended dressing coverage. Faust presented a case from plastic surgeon Dr. Anthony Dorgano involving a young woman undergoing breast reconstruction. Given the patient’s complex psychosocial background and likelihood of poor compliance, incisional NPWT was used to reduce dressing changes and improve outcomes. “These dressings can last 7 days, and the pump up to 14,” she said, noting their utility in outpatient care.
Practical Pearls for Clinicians
The session concluded with key reminders for clinicians: know the device’s labeled indications and stay current on literature supporting emerging uses; be mindful of payer requirements, which may not align with clinical judgment; and adapt treatment plans to patient needs and resources.
“Insurance coverage does not equate to your clinical judgment,” Faust stated. “Get creative when necessary—but always stay grounded in safety, evidence, and documentation.”
As NPWT technology and applications continue to evolve, sessions like this underscore the importance of clinical flexibility and informed innovation in driving better outcomes for complex wound patients.
