Wich is the Best Dressing in Wounds by Primary Surgery of THA and / or TKA?

Study Overview
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Brief Summary
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Surgical wounds are covered to prevent bleeding, absorb the exudates and provide a barrier against external contamination. Currently, in Corporació PT after orthopedic surgery, traditional occlusive dressing of sterile gauze and non-woven hypoallergenic adhesive tape is placed. In many cases the appearance of blistering caused by the use of these conventional dressings is observed, which increases the risk of infection, pain and the final cost of the procedure. There are other types of dressings that could improve these aspects but comparative data are not currently available. Main objective: to identify the dressing that better preserves the integrity of the skin. Design: Prospective randomized comparative study of 5 types of dressings used in total knee and hip arthroplasty surgical wounds (TKA and THA). Secondary Objectives: To identify the dressing that provides greater advantages and minor inconveniences in TKA and THA surgery. Study population: Patients older than 18 years undergoing fast track primary TKA or THA. 110 patients

Official Title
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Randomized Clinical Trial Comparing 5 Types Dressings in Wounds by Primary Orthopedic Surgery of Total Hip Arthroplasty and / or Knee

Conditions
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Occlusive Dressings, Nursing, Knee Surgery, Hip Surgery

Intervention / Treatment
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* Device: Aquacel Surgical®
* Device: Mepilex Border post-op®
* Device: Opsite post-op visible®
* Device: Urgotul ABSORB border silicona®
* Device: Conventional dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years operated on primary TKA and THA in the fast track circuit adequate cognitive ability. Exclusion Criteria: damaged skin no self-care capacity or caregiver inadequate cognitive ability to consent freely patients who will not undergo fast track surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional dressing<br>The conventional dressing (sterile gauzes) will be applied | Device: Conventional dressing<br>* Measuring the skin integrity with each dressing and the patient satisfaction<br>|
| Experimental: Aquacel Surgical®<br>Postoperative sterile dressing composed by non-woven inner pad (in contact with wound) Technology Hydrofiber® formed from sodium carboxymethylcellulose | Device: Aquacel Surgical®<br>* Measuring the skin integrity with each dressing and the patient satisfaction<br>|
| Experimental: Mepilex Border post-op®<br>Flexible absorbent all-in-one post-op dressing, super-absorbent fibres for high and fast absorption with optimised retention. | Device: Mepilex Border post-op®<br>* Measuring the skin integrity with each dressing and the patient satisfaction<br>|
| Experimental: Opsite post-op visible®<br>Adhesive dressing with absorbent foam in the form of a grid to visualize the wound without lifting the dressing | Device: Opsite post-op visible®<br>* Measuring the skin integrity with each dressing and the patient satisfaction<br>|
| Experimental: Urgotul ABSORB border silicona®<br>A soft-adherent TLC (Technology Lipido-Colloid) layer (polymers and hydrocolloid particles) combined with an absorbent polyurethane foam pad and a highly absorbent layer. A vapour permeable waterproof outer film with silicone adhesive on the edges. | Device: Urgotul ABSORB border silicona®<br>* Measuring the skin integrity with each dressing and the patient satisfaction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin integrity | Skin integrity is a composite endpoint including absence of any of the following items: blisters, erosion, erythema, maceration, swelling, wound dehiscence, purulent exudate) in the area of the surgical wound, measured by wound inspection | 2 weeks after surgery |