title: Feasibility, acceptability, and tolerability of RGN107 in the palliative wound care management of chronic wound symptoms.
abstract: OBJECTIVE
  To assess the feasibility, acceptability and tolerability of RGN107 use, a natural powder blend of Arnica Montana, Calendula Officinalis, Mentha Arvensis and Santalum Album, among hospice patients and their wound caregivers in the palliative wound care management of chronic wound symptoms at end-of-life.
  
  
  METHODS
  Data were collected between May 2013 and November 2015. A pilot trial conducted among 50 hospice patients with symptomatic (pain, odour, or exudate) chronic wounds. Caregivers received initial RGN107 protocol training, actively applied the powder to patient wounds for 4-weeks, and completed an 8-week retrospective survey. Feasibility was assessed by measuring process outcomes, including the number and proportion of participants referred, screened eligible, enrolled, withdrawn and successfully completed. Acceptability measures included: a protocol training evaluation, caregiver pre and post self-efficacy ratings, retrospective usability, symptom control management and comparative technique caregiver ratings, and recorded open-ended comments. Tolerability was assessed through a 12-week cumulative review of the study adverse event profile.
  
  
  RESULTS
  Feasibility, tolerability and acceptability of use of the RGN107 powder for chronic wounds were established. Recruitment goals were achieved and 92 % of the patients successfully completed the study. 95 % of wound caregivers would recommend the powder for use in this population.
  
  
  CONCLUSIONS
  This study supports the feasibility, acceptability and tolerability of a wound care powder that espouses a multi-symptom palliative comfort care approach for hospice patients with chronic wounds at end-of-life. Further research is needed to establish the efficacy of the powder.
authors.affiliation: Project Director, Medical University of South Carolina, College of Nursing, 99 Jonathan Lucas Street, MSC 160, Charleston SC 29425.
authors.forename: M
authors.initials: M
authors.lastname: Madisetti
authors.affiliation: Professor and David and Margaret Clare Endowed Chair, Medical University of South Carolina, College of Nursing, 99 Jonathan Lucas Street, MSC 160, Charleston SC 29425.
authors.forename: T J
authors.initials: TJ
authors.lastname: Kelechi
authors.affiliation: Associate Professor, Medical University of South Carolina, College of Nursing, 99 Jonathan Lucas Street, MSC 160, Charleston SC 29425.
authors.forename: M
authors.initials: M
authors.lastname: Mueller
authors.affiliation: Professor, Medical University of South Carolina, College of Nursing, 99 Jonathan Lucas Street, MSC 160, Charleston SC 29425.
authors.forename: E J
authors.initials: EJ
authors.lastname: Amella
authors.affiliation: Research Coordinator, Medical University of South Carolina, College of Nursing, 99 Jonathan Lucas Street, MSC 160, Charleston SC 29425.
authors.forename: M A
authors.initials: MA
authors.lastname: Prentice
mesh_terms: D000279:Administration, Cutaneous; D000369:Aged, 80 and over; D018650:Arnica; D020838:Calendula; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D027541:Mentha; D010147:Pain Measurement; D010166:Palliative Care; D010349:Patient Compliance; D008517:Phytotherapy; D010865:Pilot Projects; D010936:Plant Extracts / Q000008:administration & dosage / Q000627:therapeutic use*; D028321:Plant Preparations / Q000008:administration & dosage / Q000627:therapeutic use*; D003668:Pressure Ulcer / Q000188:drug therapy* / Q000451:nursing; D011446:Prospective Studies; D032123:Santalum; D014945:Wound Healing
chemical_list: D003879:Dermatologic Agents; D010936:Plant Extracts; D028321:Plant Preparations; C000632582:RGN107
keywords: chronic wounds; hospices; palliative wound care; wound exudate; wound odour; wound pain