TY - JOUR
T1 - Hard to heal pressure ulcers (stage III-IV)
T2 - Efficacy of injected activated macrophage suspension (AMS) as compared with standard of care (SOC) treatment controlled trial
AU - Zuloff-Shani, Adi
AU - Adunsky, Abraham
AU - Even-Zahav, Aviva
AU - Semo, Haim
AU - Orenstein, Arie
AU - Tamir, Jeremy
AU - Regev, Eli
AU - Shinar, Eilat
AU - Danon, David
N1 - Funding Information:
This research was supported by the Rosetree Trust, London, England and by a research grant from MDA , Israel.
PY - 2010/11
Y1 - 2010/11
N2 - The objective of this study was to compare local injections of AMS with SOC treatments for stage III and IV pressure ulcers in elderly patients. It was designed as historically prospective 2-arms non-parallel open controlled trial, and conducted in a department of geriatric medicine and rehabilitation of a university affiliated tertiary hospital. We studied 100 consecutive elderly patients with a total of 216 stage III or IV pressure ulcers, 66 patients were assigned to the AMS group and had their wounds injected, while 38 patients were assigned to the SOC group. Primary outcome was rate of complete wound closure. Time to complete wound closure and 1-year mortality served as secondary outcomes. Statistical analyses were performed at both patient and wound levels. Percentage of completely closed wounds (wound level and patient level) were significantly better (p<0.001/p<0.001, respectively) in all patients in favor of AMS, as well as in the subset of diabetic patients (p<0.001/p<0.001). Similarly, AMS proved significantly better for the subset of those with leg ulcers and with baseline wounds ≤15cm2, compared with SOC. There were no statistically significant differences with regard to time to complete closure or 1-year mortality rates in the two groups. It is concluded that there is a significant difference in favor of stage III and IV wound closure rates by AMS, as compared with SOC treatments.
AB - The objective of this study was to compare local injections of AMS with SOC treatments for stage III and IV pressure ulcers in elderly patients. It was designed as historically prospective 2-arms non-parallel open controlled trial, and conducted in a department of geriatric medicine and rehabilitation of a university affiliated tertiary hospital. We studied 100 consecutive elderly patients with a total of 216 stage III or IV pressure ulcers, 66 patients were assigned to the AMS group and had their wounds injected, while 38 patients were assigned to the SOC group. Primary outcome was rate of complete wound closure. Time to complete wound closure and 1-year mortality served as secondary outcomes. Statistical analyses were performed at both patient and wound levels. Percentage of completely closed wounds (wound level and patient level) were significantly better (p<0.001/p<0.001, respectively) in all patients in favor of AMS, as well as in the subset of diabetic patients (p<0.001/p<0.001). Similarly, AMS proved significantly better for the subset of those with leg ulcers and with baseline wounds ≤15cm2, compared with SOC. There were no statistically significant differences with regard to time to complete closure or 1-year mortality rates in the two groups. It is concluded that there is a significant difference in favor of stage III and IV wound closure rates by AMS, as compared with SOC treatments.
KW - Activated macrophage suspension
KW - Pressure ulcers
KW - Wound healing in elderly
UR - http://www.scopus.com/inward/record.url?scp=77957334356&partnerID=8YFLogxK
U2 - 10.1016/j.archger.2009.11.015
DO - 10.1016/j.archger.2009.11.015
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AN - SCOPUS:77957334356
SN - 0167-4943
VL - 51
SP - 268
EP - 272
JO - Archives of Gerontology and Geriatrics
JF - Archives of Gerontology and Geriatrics
IS - 3
ER -