title: Clinical trial to evaluate the performance of a flexible self-adherent absorbent dressing coated with a soft silicone layer compared to a standard wound dressing after orthopedic or spinal surgery: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Postoperative wound infection is a preventable risk. One potential postoperative complication is blistering, which leads to increased pain, delayed healing, and higher care costs. The incidence of wound blisters has been reported to be between 6 and 24%. The aim of this study is to assess whether the risks of postoperative blistering and wound infections within the first 6 days postsurgery will be reduced using a special dressing compared to a standard one.
  
  
  METHODS
  This is a randomized clinical trial in a University hospital. Patients presenting for knee or hip arthroplasty or spine procedures will be assessed against study inclusion and exclusion criteria. After giving written informed consent, patients will be randomized to participate in the 7-day study during hospitalization. One hundred patients will be randomized per group. The primary outcome measure is blistering incidence from day 0 to day 6 postsurgery. Photo documentation will be evaluated in a blinded manner by the Clinical Evaluation Committee (CEC).
  
  
  CONCLUSIONS
  A new dressing will be compared to the standard wound dressing regarding the risk of postoperative blistering, wound infection, and patient comfort. This study will assess the potential advantages of a modern wound dressing.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier NCT01988818 (Entered 13 November 2011).
authors: Department of Orthopedics and Trauma Surgery, University Hospital of Cologne, Kerpener Str. 62, Cologne, D - 50924, Germany. jan.bredow@uk-koeln.de.|Clinical Trials Centre, BMBF 01KN0706, University of Cologne, Kerpener Str. 62, Cologne, 50924, Germany. jan.bredow@uk-koeln.de.
authors: Jan
authors: J
authors: Bredow
authors: Department of Orthopedics and Trauma Surgery, University Hospital of Cologne, Kerpener Str. 62, Cologne, D - 50924, Germany. johannes.oppermann@uk-koeln.de.|Clinical Trials Centre, BMBF 01KN0706, University of Cologne, Kerpener Str. 62, Cologne, 50924, Germany. johannes.oppermann@uk-koeln.de.
authors: Johannes
authors: J
authors: Oppermann
authors: Clinical Trials Centre, BMBF 01KN0706, University of Cologne, Kerpener Str. 62, Cologne, 50924, Germany. studienzentrum-ortho-unfall@uk-koeln.de.
authors: Katharina
authors: K
authors: Hoffmann
authors: Institute of Medical Statistics, Informatics and Epidemiology, University of Cologne, Kerpener Str. 62, Cologne, 50924, Germany. martin.hellmich@uni-koeln.de.
authors: Martin
authors: M
authors: Hellmich
authors: Department of Orthopedics and Trauma Surgery, University Hospital of Cologne, Kerpener Str. 62, Cologne, D - 50924, Germany. birte.wenk@uk-koeln.de.|Clinical Trials Centre, BMBF 01KN0706, University of Cologne, Kerpener Str. 62, Cologne, 50924, Germany. birte.wenk@uk-koeln.de.
authors: Birte
authors: B
authors: Wenk
authors: Department of Orthopedics and Trauma Surgery, University Hospital of Cologne, Kerpener Str. 62, Cologne, D - 50924, Germany. raoul.simons@uk-koeln.de.|Clinical Trials Centre, BMBF 01KN0706, University of Cologne, Kerpener Str. 62, Cologne, 50924, Germany. raoul.simons@uk-koeln.de.
authors: Marvin
authors: M
authors: Simons
authors: Department of Orthopedics and Trauma Surgery, University Hospital of Cologne, Kerpener Str. 62, Cologne, D - 50924, Germany. peer.eysel@uk-koeln.de.|Clinical Trials Centre, BMBF 01KN0706, University of Cologne, Kerpener Str. 62, Cologne, 50924, Germany. peer.eysel@uk-koeln.de.
authors: Peer
authors: P
authors: Eysel
authors: Department of Orthopedics and Trauma Surgery, University Hospital of Cologne, Kerpener Str. 62, Cologne, D - 50924, Germany. kourosh.zarghooni@uk-koeln.de.|Clinical Trials Centre, BMBF 01KN0706, University of Cologne, Kerpener Str. 62, Cologne, 50924, Germany. kourosh.zarghooni@uk-koeln.de.
authors: Kourosh
authors: K
authors: Zarghooni
mesh_terms: D000268:Adhesiveness; D019644:Arthroplasty, Replacement, Hip / Q000009:adverse effects; D019645:Arthroplasty, Replacement, Knee / Q000009:adverse effects; D001458:Bandages; D001768:Blister / Q000175:diagnosis / Q000382:microbiology / Q000517:prevention & control*; D002985:Clinical Protocols; D020099:Coated Materials, Biocompatible; D004867:Equipment Design; D005858:Germany; D006785:Hospitals, University; D006801:Humans; D008422:Materials Testing; D019637:Orthopedic Procedures / Q000009:adverse effects*; D017060:Patient Satisfaction; D012107:Research Design; D012307:Risk Factors; D012828:Silicones; D013131:Spine / Q000601:surgery*; D013530:Surgical Wound Infection / Q000175:diagnosis / Q000382:microbiology / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome; D014945:Wound Healing
chemical_list: D020099:Coated Materials, Biocompatible; D012828:Silicones