Jan Bredow1, Katharina Hoffmann, Johannes Oppermann, Martin Hellmich, Peer Eysel, Kourosh Zarghooni. 1. Department of Orthopedics and Trauma Surgery, University Hospital Cologne, Germany; Institute of Medical Statistics and Computational Biology (IMSB), University of Cologne, Germany; Spine Surgery, Schön Klinik Düsseldorf SE & Co. KG, Düsseldorf, Germany.
Abstract
BACKGROUND: Lower-limb endoprosthetic operations and spinal operations are among the more common types of orthopedic procedures. Postoperative woundhealing disturbances and infections can lead to longer periods of hospital stay and recovery as well as to higher morbidity and mortality. METHODS:209 patients who had been judged to have an indication for a primary knee or hip endoprosthesis or for a primary spinal operation were included in this randomized trial (ClinicalTrials.gov: NCT01988818) over the period June 2014- February 2015. After randomization, patients in the intervention group were given a trial dressing (Mepilex-Border Post-Op) and those in the control group were given a conventional adhesive dressing (Cosmopor). The primary endpoint was blister formation. RESULTS: In the overall study population, only a single case of blister formation was seen. The affected patient belonged to the intervention group but was mistakenly given a control dressing and developed blisters on the 6th day after surgery. Dressings were changed less frequently in the intervention group, and this difference was statistically significant (p<0.001). The patients, nurses, and physicians all expressed greater satisfaction with the trial dressings than with the control dressings (p<0.001). CONCLUSION: The intervention group did not differ from the control group with respect to the primary endpoint, postoperative blister formation. The patients, nurses, and physicians all judged the dressing used in the intervention group more favorably than the conventional dressing.
RCT Entities:
BACKGROUND: Lower-limb endoprosthetic operations and spinal operations are among the more common types of orthopedic procedures. Postoperative woundhealing disturbances and infections can lead to longer periods of hospital stay and recovery as well as to higher morbidity and mortality. METHODS: 209 patients who had been judged to have an indication for a primary knee or hip endoprosthesis or for a primary spinal operation were included in this randomized trial (ClinicalTrials.gov: NCT01988818) over the period June 2014- February 2015. After randomization, patients in the intervention group were given a trial dressing (Mepilex-Border Post-Op) and those in the control group were given a conventional adhesive dressing (Cosmopor). The primary endpoint was blister formation. RESULTS: In the overall study population, only a single case of blister formation was seen. The affected patient belonged to the intervention group but was mistakenly given a control dressing and developed blisters on the 6th day after surgery. Dressings were changed less frequently in the intervention group, and this difference was statistically significant (p<0.001). The patients, nurses, and physicians all expressed greater satisfaction with the trial dressings than with the control dressings (p<0.001). CONCLUSION: The intervention group did not differ from the control group with respect to the primary endpoint, postoperative blister formation. The patients, nurses, and physicians all judged the dressing used in the intervention group more favorably than the conventional dressing.
Authors: Kelvin Y Kim; Afshin A Anoushiravani; William J Long; Jonathan M Vigdorchik; Ivan Fernandez-Madrid; Ran Schwarzkopf Journal: J Arthroplasty Date: 2017-04-12 Impact factor: 4.757