Nonsurgical Management of Pressure Injury With a New Silicone Rubber Negative Pressure Wound Therapy With Instillation Device: A Case Report

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Stage 3 and 4 PIs pose a significant health care problem that can decrease patient quality of life and increase mortality rates.^1,2 A 2015 study revealed that the mortality rate among patients with stage 3 and 4 PIs treated at a hospital in Jerusalem, Israel, was as high as 72%.³ Meanwhile, a recent study reports that the cost of stage 3 and 4 PIs in the United States amounts to more than $13.4 billion annually.⁴ 

Stage 3 and 4 PIs are commonly managed by surgical debridement and flap-based reconstruction⁵; however, the recurrence of PIs after flap reconstruction is nearly 70%.⁶ In addition, flap reconstruction can only be performed on a clean wound with healthy granulation tissue.⁷ Most patients need to undergo a drastic wound debridement prior to flap reconstruction, but many are unable to tolerate surgical management because of poor nutritional status, severe infection, and various complications. NPWTi-d with a ROCF-CC may be a suitable alternative for wound cleaning in complex cases with thick exudate and slough when complete surgical debridement is not possible or appropriate.^8-10 However, the recommended duration for using NPWTi-d with ROCF-CC is no more than 9 days, in order to avoid growth of granulation tissue into the dressing and resultant pain at dressing changes.¹¹ Moreover, patients still require flap reconstruction to repair the PI after NPWTi-d. 

The patient described herein was treated with an NPWTi-d device designed by the author (Y. Zhai) that uses silicone rubber as the primary material and has a unique column structure. The device was able to remove thick wound exudate continuously without blockage, and the granulation tissue did not grow into the dressing. The results reveal a positive effect of this new anti-blocking negative pressure drainage tube with instillation device on a complex PI without the need for surgical management. 

An 81-year-old male presented with 3 stage 4 PIs—1 sacral, 1 on the right heel, and 1 on the left heel—that had been present for 6 months. At the time he transferred to the authors’ hospital, he had not eaten for 1 week. His previous medical history included hypertension and advanced dementia. He had been bedridden for 5 years.

The patient’s vital signs were monitored at presentation to the hospital, revealing a temperature of 37.1°C, heart rate of 96 beats per minute, respiratory rate of 24 breaths per minute, systolic blood pressure of 150 mm Hg and diastolic blood pressure of 60 mm Hg, and SpO2 of 89%. The laboratory examination showed a high leukocyte count, a high level of C-reactive protein (91.3 mg/L), and hypoalbuminemia (23.0 g/L) (Table).

The Mini Nutritional Assessment score was 3 (on a scale of 0 to 14, a score < 7 means malnutrition), and a chest computed tomography scan revealed evidence of pneumonia. There was a 15-cm × 10-cm–diameter eschar on the sacral region (Figure 1A), a 4-cm × 3-cm–diameter eschar on the right heel (Figure 1B), and a 4-cm × 6-cm–diameter eschar on the left heel (Figure 1C). The wounds produced exudate and a strong odor, and the skin surrounding the wounds was red and swollen. The ankle-brachial index was 0.98 for the right leg and 0.97 for the left leg. Arterial lower limb Doppler ultrasonography showed lower limb arterial plaque, but no stenosis or occlusion.

After the patient’s admission to the hospital, consistent and permanent pressure relief was achieved by changing his position every 2 to 3 hours during the day and night. Due to swallowing impairment, nasogastric feeding was used to provide nutrition. Antibiotic treatment was administered for 14 days. Due to his progressive dementia, pneumonia, low SpO2, severe hypoalbuminemia, and malnutrition, the patient was considered unable to tolerate surgical management.

The eschars were removed at the bedside without thorough debridement. The PIs extended to deep fascia, muscle, and bones. The new NPWTi-d device (Rongke [Suzhou] Medical Technology Company, Ltd), which uses silicone rubber as the primary material, was applied to the wounds (Figure 1D-F). The silicone rubber dressings were placed on the wound beds and sealed with a medical-grade transparent film; the dressings were changed every 5 days. Negative pressure was set at −125 mm Hg. The wounds were washed with 1000 mL of normal saline every 24 hours.

About 30% of the nonviable tissues had been removed and replaced by healthy granulation tissue at the first dressing change 5 days after initial application of the new anti-blocking negative pressure drainage tube with instillation device (Figure 1G-I). On day 15, the wound beds on the sacral region and right heel were covered with healthy granulation tissue. The wound bed on the left heel was covered with healthy granulation tissue by day 20. The PIs gradually shrank in size with the consecutive application of the new device. The wounds on the right heel, left heel, and sacral region were filled with healthy granulation tissue by day 20 (Figure 1K), day 25 (Figure 1L), and day 80 (Figure 1J), respectively. Subsequently, the device was no longer used, and the wounds were treated with conventional moist wound dressings. Complete wound healing was achieved on the right heel, left heel, and sacral region on day 28 (Figure 1N), day 32 (Figure 1O), and day 96 (Figure 1M), respectively. The PIs had not recurred as of 1-year follow-up (Figure 1P-R).

Stage 3 and 4 PIs pose a severe clinical challenge because of the presence of complex chronic diseases and poor nutritional status. Management of such injuries requires numerous dressing changes, which are typically helpful if patients cannot tolerate sharp debridement and flap-based reconstruction. Consequently, new therapeutic approaches for this patient population are being explored. 

It is well known that NPWT is widely applied for managing stage 3 and 4 PIs after debridement to promote the formation of granulation tissue and prepare for flap reconstruction.^12-15 However, NPWT is not recommended for PIs in the absence of debridement, because the holes in NPWT dressings can be easily blocked by thick exudate and necrotic debris, even with additional fluid instillation.^16,17

In the current case, a new anti-blocking negative pressure drainage tube with instillation device was applied to the ulcers. This device was first used for an infected wound after internal fixation of a fracture, and that wound healed without radical debridement or removal of the internal fixation. Next, the authors of the current article successfully cured an infected complex calciphylaxis wound.¹⁸ In vitro experiments showed that the new silicone rubber negative pressure dressing presented better anti-blocking properties than the polyurethane foams (data not shown).

The new device discussed herein comprises a principal, a connector, an instillation, and a negative pressure drainage tube (Figure 2).

The principal tube is made of medical-grade silicone rubber; its central part is an instillation channel connected to the instillation tube, covered with columnar structures. The connector tube joins the remaining tubes to ensure optimal fluid flow under negative pressure. The steps in applying the device are shown in Figure 3.

The smooth surface of the new device dressing discourages adherence of thick wound exudate and necrotic debris, and the unique columnar structure provides sufficient space for their passage, thus preventing any blockages. The unique columnar structure of the new device also provides sufficient space for granulation growth, and its smooth surface prevents granulation from adhering, thus preventing pain and bleeding during dressing changes. The additional instillation feature of the new system differs from traditional NPWTi-d in that the water outlet is located away from the end of the negative pressure tube (Figure 2), thus ensuring the whole wound bed is thoroughly instilled.

The current case report has limitations. Only 1 patient was studied. The evidence concerning the effectiveness of the device is low due to a lack of controlled trials. More cases and large randomized clinical studies are needed to further assess the efficacy of the new anti-blocking negative pressure drainage tube with instillation device and to optimize the clinical parameters.

The current article reports a patient with 3 PIs that were successfully treated using a new silicone rubber NPWT with instillation device without surgical management. The device was applied to the wounds for up to 80 days (in the case of the sacral wound), until the wounds were filled with healthy granulation tissue. Dressing change was done every 5 days. There was no blockage during the procedure, and no pain or bleeding during the dressing changes, which is believed to be due to the device’s smooth silicone rubber surface, unique columnar structure, and instillation loop. Additional studies with more patients are needed to further assess the efficacy of this new device.