ABSTRACT
INTRODUCTION: The first prospective noninterventional registry study (RESPOND) evaluated the clinical effectiveness of a native type I collagen matrix plus polyhexamethylene biguanide antimicrobial barrier (PCMP) in various nonhealing wounds. This product is intended for the management of partial- and full-thickness wounds and acts as an effective barrier to reduce microbes penetrating through the dressing. The RESPOND study demonstrated that PCMP has clinically meaningful benefits in managing a variety of wounds. OBJECTIVE: The authors describe the effects of PCMP in the subgroup of patients with pressure injuries (PIs) from the RESPOND registry. MATERIALS AND METHODS: The prospective, noninterventional study was designed to collect information regarding the use of PCMP in a real-world situation. Eligibility included male and female patients aged 18 years and older with target wounds (partial- or full-thickness) suitable for the use of PCMP. Enrolled patients were followed approximately weekly for up to 32 weeks. All wounds and the subgroups were analyzed to determine the frequency and median time to wound closure using Kaplan-Meier methods. RESULTS: The patients with PIs were older adults with a mean age of 69 years and a mean BMI of 27 kg/m2. At baseline, the mean measured wound length was 3 cm, the mean depth was 8.0 mm, the mean volume was 12.6 cm3, and the mean area was 10.5 cm2. Complete wound closures were evident in 5% of patients (n = 2) at week 4, and were achieved in 39% of patients (n = 18) by week 16, in 49% (n = 22) by week 24, and in 62% (n = 28) by week 32. The median time to wound closure was 32 weeks. For all 45 PIs managed with PCMP, the incidence of achieving greater than 60% reduction in baseline area and depth was 78% (n = 35) and 64% (n = 29), respectively, with approximately 82% (n = 37) of wounds showing a reduction in volume greater than 75%. CONCLUSIONS: It appears that PCMP is a useful adjunct in managing chronic deep wounds such as PIs.