Patients receiving chemotherapy, e.g., doxorubicin, cyclophosphamide, vincristine, prednisone, intrathecal therapy, high-dose methotrexate with alkalinization and hyperhydration, were enrolled upon hospitalization in the IRB approved study. The liquid protectant was applied to the diaper skin regions upon resolution of open wounds and evaluated daily. A zinc ointment was applied liberally at every diaper change. The skin was cleansed daily via oatmeal soaks to remove the loosely adherent protective film. It was evaluated for erythema and standardized digital images taken to quantify area and erythema. Absolute neutrophil counts, urine/stool output, and medications were tracked with skin scores and images over time.
Eleven patients, aged 3.8 – 44 months, were followed for 3 – 395 days for 1137 treatment days (103 ± 128). Three underwent chemotherapy and hematopoietic cell transplantation. The regimen was well tolerated. No subject required pain medication for diaper changes and there were no delays in administration of chemotherapy due to skin compromise. Skin scores were low despite absolute neutrophil counts of zero for many study days. Stool exposure was sufficient to remove the protectant, necessitating daily application and close monitoring. The regimen has been effective for the prevention and mitigation of severe skin compromise and is being implemented as the standard of care.