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

Not Applicable

Completed

• Conditions: Wound Healing
• Interventions: Procedure: Postop Dressing

• Registration Number: NCT01258270
• Lead Sponsor: OrthoCarolina Research Institute, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-09
• Study First Submitted QC: 2010-12-09
• Study First Posted: 2010-12-10
• Status Verified: 2012-01
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-06-06
• Last Update Posted: 2013-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Patients presenting for primary total hip performed through a posterior or posterior-lateral surgical approach or primary total knee arthroplasty
2. Patients between the ages of 18 and 90
3. The subject is willing and able to understand, sign and date the study specific patient Informed Consent, to volunteer participation in the study
4. The subject is having surgery at a Carolinas HealthCare System facility
5. The subject is psychosocially, mentally and physically able to comply with the requirements of the study

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Exclusion Criteria

1. Patients presenting for revision total hip or total knee arthroplasty
2. Patients with topical hypersensitivity or allergy to any disposable components of the dressing system such as: ionic silver, polyurethane film
3. 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
4. Patients currently participating in another clinical trial that may affect your participation in this trial
5. Patients with insurance coverage not included in Gentiva list of payers
6. Patients residing outside of Gentiva's geographical coverage area
7. Patients having surgery at a NON-Carolinas HealthCare System facility

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
(AQUACEL® Ag Surgical Dressing	Postop Dressing	-
Standard island gauze and tape dressing	Postop Dressing	A standard island dressing consists of adhesive tape and gauze.

Primary Outcome Measures

Name	Time	Method
The incidence of postoperative severe skin reactions (defined as blisters) around the surgical incision site	4 weeks postop	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.

Secondary Outcome Measures

Name	Time	Method
Patient pain and satisfaction (1-100 visual analog scale)	immediate postop, 5-7 days postop, 4 weeks postop

Trial Locations

Locations (1)

OrthoCarolina, PA; 🇺🇸 Charlotte, North Carolina, United States