Quality of Life Improvement in Patients with Chronic Leg Wounds that were Treated with Wound Irrigation Solution* and Wound Gel+ each Containing Polyhexanide (PHMB) and Betaine

Rationale: Improving health-related quality of life (QoL) is important for patients living with chronic wounds. Chronic wounds don’t progress timely through the normal healing process.  Physical symptoms, especially pain and odor, can dominate everyday living, affecting mobility, disrupting sleep, affecting work and social activities. This prospective, open-label, single-arm, five center study evaluated the impact of four weeks of treatment with Wound Irrigation Solution* and Wound Gel+ (each containing Polyhexanide [PHMB] and Betaine) on adults with chronic leg wounds. 
Objectives: This study assessed the overall change (Weeks 1 to 5) in the global QoL, changes in the subscores: Body, Psyche, Everyday Life (EDL), and changes in the appearance and size of the wounds after treatment with PHMB and Betaine in patients with chronic leg wounds. 
Methods: Non-hospitalized patients with no more than two wounds below the knees were recruited into the study. Wounds were ≥5 to ≤50 cm2 and present for ≥4 weeks. Investigator or designee applied the PHMB and Betaine to the wounds at clinic visits and patients/caregivers applied the PHMB and Betaine at home. Wound-QoL questionnaires were obtained at screening and each week of treatment. Wound size and photographs were obtained at pre- and post-treatment during clinic visits. Patients completing at least all Week 2 assessments and the Week 3 Wound-QoL questionnaire were eligible for statistical analyses. 
Conclusion: This study demonstrates a marked improvement in the QoL of patients with chronic leg wounds below the knee after four weeks of treatment. Mean Global QoL scores decreased by 1.112 (46.1%). Body, Psyche and EDL decreased by 1.172 (60.0%), 1.261 (41.8%) and 1.003 (42.2%), respectively. All p-values were < 0.0001. Wounds also showed improvement in odor, appearance and size.
Adverse events were minor and mild in intensity. PHMB and Betaine were well tolerated by the patients.

Trademarked Items (if applicable): *Prontosan® Wound Irrigation Solution, B. Braun Medical Inc., Bethlehem, PA
+Prontosan® Wound Gel, B. Braun Medical Inc., Bethlehem, PA

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