Open-label randomized controlled trial to compare wound dressings for patients undergoing hip and knee arthroplasty: study protocol for a randomized controlled trial

Abstract

Background: Surgical wounds are covered to prevent bleeding, absorb the exudates, and provide a barrier against external contamination. Currently, in our hospital, after orthopedic surgery, traditional occlusive dressing of sterile gauze and non-woven hypoallergenic adhesive tape is placed. Some of the newest dressings have been shown to reduce the incidence of blisters compared with traditional dressing or colloid adhesive dressings. However, there are no comparative evaluations between the different types of dressings and their contribution to the overall results of the healing process.

Methods/design: This is a randomized, controlled, open-label trial to compare five types of dressings used in total knee and hip arthroplasty surgical wounds. A total of 550 patients will be randomly allocated to one of the following dressings: (1) traditional occlusive dressing, (2) Aquacel Surgical®, (3) Mepilex® Border Post-Op, (4) OpSite Post-Op Visible, or (5) UrgoTul® Absorb Border. The dressing assigned is placed right after surgery. Patients will be followed up to 14 days after surgery when the dressing is definitively removed and will be tracked up to 3 months to record any late complications. During the immediate postoperative period and patient hospitalization and at the ambulatory visits after discharge, every time that the dressing is changed, nurses perform the study assessments. The main study outcome will be the percentage of patients with skin integrity at all times when the dressing has been changed. Skin integrity is a composite of the absence of blisters, erosion, erythema, maceration, swelling, wound dehiscence, and purulent exudates. Secondary outcomes include time to first change of dressing; percentage of patients with presence/absence of blisters, erosion, erythema, maceration, swelling, wound dehiscence, and purulent exudates; number of dressing changes needed; days of hospital stay; and nurse and patient satisfaction. Differences in the main variable between each treatment group and group 1 will be tested by means of a chi-squared test or Fisher's exact test. Subgroup analyses of diabetic and non-diabetic patients, patients with a body mass index of more than 30 or not more than 30, and type of surgery (hip or knee) are planned.

Discussion: The results of this study will be useful for clinical decision making by giving information on the contribution of the dressings studied to the outcome of the wound and may also show which dressing offers better results depending on the characteristics of patients.

Trial registration: This trial has been registered at ClinicalTrials.gov ( NCT03190447 ). Retrospectively registered on 16 June 2017.

Keywords: Arthroplasty; Hip (MeSH); Knee; Nursing; Occlusive dressings; Replacement.

Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the research ethics committee of our center (Comité Ético de Investigación Clínica de la Corporació Sanitària Parc Taulí) in January 2017. All participants are informed and are asked for informed consent before any study procedure.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1

Schedule of enrolment, interventions, and assessments. (1) If needed. (2) Only if the dressing is changed