Smart-C

Smart-C is a wearable band and smartphone application system for automated detection of post-C section surgical site infections.

Cesarean delivery (CD) accounts for over 29 million births annually, and this number continues to increase every year. Surgical site infection (SSI) is a common complication following CD, with an incidence rate of 3%–15% worldwide. Post C Section SSI is a significant cause of maternal morbidity and mortality along with posing a significant financial burden to healthcare systems (SSIs have an associated cost of $4670–$5500 per case in the U.S.)

Left untreated, surgical site infections can have multiple local and systemic implications which cause intense pain and discomfort, require longer courses of antibiotics, and result in hospital readmission. In the worst cases, the patient is at risk for sepsis, which is the second and third highest cause of maternal mortality in the United States and worldwide, respectively.

Symptoms of SSI typically appear 4-7 days after delivery, when most patients have been discharged from the hospital, but can occur as late as 30 days post-delivery. Currently, patients are expected to self-monitor their wound for pain and redness after being sent home. However self monitoring can be challenging due to numbness at the local wound site and coping with hectic lifestyle changes. As an additional hurdle, many patients who undergo C-sections also have a pannus, an extra flap of fat that hangs from the abdomen, obscuring the wound site from visualization. The pannus makes it challenging to regularly clean the surgical site and visually track signs of infection. Although follow up appointments are intended to monitor for postpartum complications, there is often low adherence in the hectic weeks following delivery.

Thus, there is a clear need for at-home, automated detection of post-CD SSI with non-visual physiological indicators to alleviate the challenges of self-monitoring the wound site. By detecting infection as soon as possible, patients can seek care before the infection progresses into severe complications.

Our solution is a wearable band and mobile application system that will detect and track signs of SSI in the postpartum period. Smart-C will continuously track pH and temperature elevations around the wound site, which are associated with the early stages of surgical site infection. The band is intended to be worn for 12 continuous hours each day (it can be removed while sleeping). The automated monitoring system will reduce the burden on new mothers to self-monitor their wound site during a hectic post-delivery period. Our product will encourage women to seek care early, minimizing severe complications and costs associated with advanced SSIs.

The wearable band is designed to be comfortable, compressive, and size-inclusive. The band is built with flexible electronics to maintain a sleek design and the textile pH sensor is coated with an antimicrobial polymer to fight infection. The pH and temperature sensors are integrated within an interchangeable, moisture-wicking dressing that keeps the wound's surface dry.

The accompanying mobile application will display hourly pH and temperature measurements. This data will be passed through an infection detection algorithm and the app will alert the patient if there is an upward trend in pH and temperature. We referenced numerous physicians and medical literature to determine diagnostic thresholds for these biomarkers. If an elevated pH and temperature is detected, the patient will be prompted to assess whether there are additional changes in pain, discomfort, or wound appearance (if it can be visualized). Using the biomarker data and the patient’s self-assessment, Smart-C will encourage the patient to contact a physician if an infection is likely.

After a CD in the United States, women remain in the hospital for 3 days, where nurses monitor for signs of infection. After the mother goes home, they are responsible for self-monitoring for signs of infection. We envision this product being given to women high-risk for infection after a C-section.
When a woman is leaving the hospital, we envision the wearable band and a box of disposable pH-sensing Exu-Dry being a part of the postpartum care package given to high-risk women, reimbursed by insurance (like some existing CD products), or subsidized by the hospital.

Around the world, the C-section operations are becoming increasingly prevalent along with associated surgical site infections. With cutting-edge technology emerging for wearable devices, such as new power sources and flexible electronics, we believe this is the right moment for us to pursue Smart-C. Moreover, the U.S. has recently expanded postpartum Medicaid coverage, which is favorable for future reimbursement negotiations.

 Our team consists of five Bioengineering students who have completed comprehensive coursework in medical device development and commercialization. Additionally, some of our founders have worked for other medical device startups, which has provided us with valuable experience that we can apply to the venture. Our team was formed from a shared passion for promoting women’s health and healthcare equity. Since last summer, we’ve spent countless hours interviewing a number of OB/GYNs, both in the US and in Africa, wound care nurses, obstetrics nurses, infection control specialists, and C-section patients with infection complications about the need for our device. We are closely collaborating with our clinical mentor, Stephanie Modri MSN, RN, C-MNN, who has an extensive network of patients and physicians in labor & delivery. From our initial interviews, we have received very positive feedback for the development of Smart-C.

Since last summer, we’ve spent countless hours interviewing a number of

OB/GYNs, both in the US and in Africa, wound care nurses, obstetrics
nurses, infection control specialists, and C-section patients with
infection complications about the need for our device. We are closely
collaborating with our clinical mentor, Stephanie Modri MSN, RN, C-MNN,
who has an extensive network of patients and physicians in labor &
delivery. From our initial interviews, we have received very positive
feedback for the development of Smart-C.

Smart-C utilizes unique integration of technology that is tailored to the needs of post C-section patients by providing automated, continuous monitoring of non-visual indicators of infections. There are no commercially available products for at home SSI detection. Flexible electronics and bio-sensing textiles are still in the development stage within the wound care field. Current research focuses on monitoring chronic wounds, which possess a different infection pathophysiology than surgical sites. Our solution is designed to detect rapid short-term changes in wound biomarker levels utilizing small levels of fluid around a wound site. Furthermore, post-CD surgical site wounds should be cleaned often, requiring a monitoring solution that can be changed daily.

In addition, there is limited research being done on developing objective and quantifiable metrics for SSI clinical diagnosis. The data collected by our device can train and fine-tune future models for infection detection. Notably, utilizing pH for infection detection is relatively novel in the wound care field. Smart-C can provide valuable insight into how biomarkers vary over the progression of surgical site infection.