events (AEs)was comparable between the treatment groups
over the 12-week study period; however, study ulcer-related AEs
involving local infection, osteomyelitis, or cellulitis were less frequent
in the HFDS group versus the control group (19.0% vs 32.5%,
P = .007). Although not statistically significant, a lower percentage
of HFDS-treated patients underwent a surgical procedure that involved
the study ulcer (ie, surgical debridement more extensive than
required by the protocol, incision and drainage, revision, excision/
resection, or amputation) when compared with control-treated patients
(8.0%vs 14.6%, P = .07).8 The overall rate ofamputation and
bone resection was not reported. In addition, the relationship
between the treatment administered and the incidence of lowerextremity
amputation or bone resection related to the study ulcer had
not been explored. A previous report was published on the outcomes
of amputation/bone resection froma clinical study evaluating
the treatment ofDFUs using a bilayered living skin equivalent.10,11
Because of the clinical relevance in this population, a retrospective
analysis of the incidence of amputation/bone resection was conducted
using the data collected in the HFDS study.8
The authors present herein an analysis of the procedures involving
amputation/bone resection that occurred during the 12-week
pivotal trial for HFDS in the treatment of DFUs. The overall incidence
of amputation/bone resection is presented by treatment group.
In addition, the odds ratio for amputation/bone resection is presented
for patients having various associated risk factors for such procedures
events (AEs)was comparable between the treatment groupsover the 12-week study period; however, study ulcer-related AEsinvolving local infection, osteomyelitis, or cellulitis were less frequentin the HFDS group versus the control group (19.0% vs 32.5%,P = .007). Although not statistically significant, a lower percentageof HFDS-treated patients underwent a surgical procedure that involvedthe study ulcer (ie, surgical debridement more extensive thanrequired by the protocol, incision and drainage, revision, excision/resection, or amputation) when compared with control-treated patients(8.0%vs 14.6%, P = .07).8 The overall rate ofamputation andbone resection was not reported. In addition, the relationshipbetween the treatment administered and the incidence of lowerextremityamputation or bone resection related to the study ulcer hadnot been explored. A previous report was published on the outcomesof amputation/bone resection froma clinical study evaluatingthe treatment ofDFUs using a bilayered living skin equivalent.10,11Because of the clinical relevance in this population, a retrospectiveanalysis of the incidence of amputation/bone resection was conductedusing the data collected in the HFDS study.8The authors present herein an analysis of the procedures involvingamputation/bone resection that occurred during the 12-weekpivotal trial for HFDS in the treatment of DFUs. The overall incidenceof amputation/bone resection is presented by treatment group.In addition, the odds ratio for amputation/bone resection is presentedfor patients having various associated risk factors for such procedures
การแปล กรุณารอสักครู่..
