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/design: 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).

Discussion: 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.

Trial registration: ClinicalTrials.gov identifier NCT01988818 (Entered 13 November 2011).

Figures

Figure 1

Flow diagram of the progression through the randomized 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 surgery.