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

BackgroundPostoperative 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/DesignThis 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).DiscussionA 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 registrationClinicalTrials.gov identifier NCT01988818 (Entered 13 November 2011).

Evaluation of Absorbent Versus Conventional Wound Dressing

“…The primary study hypothesis that the use of absorbent wound dressing will reduce blistering was not confirmed. For conventional adhesive dressings, blistering rates of 6 to 24% have been reported in the literature (13,23). However, these findings were not confirmed in our patient population.…”

“…The primary endpoint of this study was the incidence of blistering in patients after total hip or knee replacement or after primary spinal surgery. The sample size was calculated on this basis (13). Secondary endpoints were dressing performance, wearing Intention-to-treat (ITT) analysis (n = 105) Per-protocol analysis (n = 105) As-treated analysis (n = 110) excluded from analysis (n = 1) → Intervention not received, since no surgery was performed (n = 1)…”

“…The detailed study protocol of this study was published in advance (13). The randomization method used is depicted in the CONSORT flowchart ( Figure).…”

“…In patients with risk factors, such as diabetes mellitus, advanced age, ischemia, and bacterial infection, seemingly small and harmless wounds can lead to complications and chronic wounds (7). The incidence of complications of wound healing after primary orthopedic knee and hip procedures is reported to be 0 to 1.25% (5,(8)(9)(10)(11)(12) and even 0 to 16% after spinal surgery (1,(13)(14)(15). After elective orthopedic surgery, sepsis occurred in 0 to 0.34% of patients (16,17).…”

“…Besides impaired wound healing, blistering is a potential post-operative complication with incidence rates of 6 to 24% reported in the literature (12,13,19,20). Lack of elasticity and insufficient flexibility of adhesive dressings are among the factors promoting the formation of blisters (21,22).…”