Feasibility, acceptability, and tolerability of RGN107 in the palliative wound care management of chronic wound symptoms.
M Madisetti, T J Kelechi, M Mueller and 2 others
PMID 28105900WHAT IT FOUND
46 of 50 hospice dyads reached study completion endpoints, but only 25 of 50 finished active 4-week powder application; many caregivers rated it easy and recommended it, with 2 mild product-related events.
No efficacy shown.
Key findings
01Of 50 enrolled hospice patient-caregiver dyads, 46 reached successful study completion endpoints, but only 25 completed the active 4-week RGN107 application phase.
02At post-exit, 96.9% of professional and 88.9% of non-professional caregivers would recommend RGN107 to other caregivers.
032 adverse events were graded as related or possibly related to RGN107: 1 periwound inflammation and 1 allergic skin reaction in a patient with undisclosed ragweed allergy.
STILL TO COME
How it was doneWhat they foundWhat it means for RNs
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What it does not show
The sample was small and this was a feasibility pilot, so it cannot show whether RGN107 improves wound symptoms or healing. The study was open-label and had no control group, so caregiver ratings cannot be compared with usual care as evidence of effect. Only 25 of 50 patients completed the active 4-week application phase, and early exits were related to patient decline, caregiver burden, odour, wound size or undisclosed allergy. Acceptability ratings were collected retrospectively 4 weeks after study exit, and caregiver memory may have degraded. The paper reports feasibility, acceptability and tolerability outcomes, not a tested efficacy outcome. Hospice nurses could care for multiple study patients, and ratings were subjective, so bias and limited generalisability are possible.
The easy way to misread this
Do not read high caregiver acceptability and symptom-control ratings as proof that RGN107 works better than standard wound care. The study was an open-label pilot with no control group, only 25 of 50 completed the active 4-week phase, and ratings were collected retrospectively after study exit.