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

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

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.

Study Overview

• Status: Completed
• Conditions: Wound Healing
• Intervention / Treatment: Procedure: Postop Dressing; Procedure: Postop Dressing

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: (AQUACEL® Ag Surgical Dressing	Procedure: Postop Dressing; 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.; Procedure: Postop Dressing; A standard island dressing consists of adhesive tape and gauze.
Active Comparator: Standard island gauze and tape dressing; A standard island dressing consists of adhesive tape and gauze.	Procedure: Postop Dressing; 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.; Procedure: Postop Dressing; A standard island dressing consists of adhesive tape and gauze.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: OrthoCarolina Research Institute, Inc.
• Collaborators: ConvaTec Inc.
• Investigators: Principal Investigator: Bryan D Springer, MD, OrthoCarolina, PA

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: December 9, 2010
• First Submitted That Met QC Criteria: December 9, 2010
• First Posted (Estimate): December 10, 2010

Study Record Updates

• Last Update Posted (Estimate): June 10, 2013
• Last Update Submitted That Met QC Criteria: June 6, 2013
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 10-10-01A