Efficacy and Patient Satisfaction With AQUACEL® Ag Surgical Dressing Compared to Standard Surgical Dressing

Study Overview
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Brief Summary
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The objective of this study is to determine the safety and effectiveness of the AQUACEL® Ag Surgical Dressing (treatment group) as compared to prepackaged island wound dressings consisting of traditional tape and gauze (control group) for total hip and total knee arthroplasty.

Official Title
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Efficacy and Patient Satisfaction With AQUACEL® Ag Surgical Dressing Compared to Standard Surgical Dressing. A Prospective, Randomized Study in Primary Total Joint Arthroplasty.

Conditions
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Wound Healing

Intervention / Treatment
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* Procedure: Postop Dressing
* Procedure: Postop Dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting for primary total hip performed through a posterior or posterior-lateral surgical approach or primary total knee arthroplasty Patients between the ages of 18 and 90 The subject is willing and able to understand, sign and date the study specific patient Informed Consent, to volunteer participation in the study The subject is having surgery at a Carolinas HealthCare System facility The subject is psychosocially, mentally and physically able to comply with the requirements of the study Exclusion Criteria: Patients presenting for revision total hip or total knee arthroplasty Patients with topical hypersensitivity or allergy to any disposable components of the dressing system such as: ionic silver, polyurethane film Any systemic or local active dermatological disease that might interfere with the evaluation of the surgical site such as eczema, psoriasis, skin cancer, scleroderma, chronic urticaria Patients currently participating in another clinical trial that may affect your participation in this trial Patients with insurance coverage not included in Gentiva list of payers Patients residing outside of Gentiva's geographical coverage area Patients having surgery at a NON-Carolinas HealthCare System facility

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: (AQUACEL® Ag Surgical Dressing<br> | Procedure: Postop Dressing<br>* The AQUACEL® Ag Surgical Dressing is a silver impregnated, waterproof, adhesive dressing that sticks to the skin around the wound and blocks bacteria from the outside.<br>|
| Active Comparator: Standard island gauze and tape dressing<br>A standard island dressing consists of adhesive tape and gauze. | Procedure: Postop Dressing<br>* A standard island dressing consists of adhesive tape and gauze.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of postoperative severe skin reactions (defined as blisters) around the surgical incision site | Wound checks will be performed during the postoperative period in the hospital followed by home healthcare providers. The final wound check will be performed by the surgeon at 4 weeks postoperatively. | 4 weeks postop | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient pain and satisfaction (1-100 visual analog scale) |  | immediate postop, 5-7 days postop, 4 weeks postop |