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

Wound Healing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01258270
• Other study ID #: 10-10-01A
• Status: Completed
• Phase: N/A
• First received: December 9, 2010
• Last updated: June 6, 2013
• Start date: December 2010
• Est. completion date: May 2013

Study information

• Verified date: January 2012
• Source: OrthoCarolina Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wound Healing

Intervention

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.
• Postop Dressing
A standard island dressing consists of adhesive tape and gauze.

Locations

Country	Name	City	State
United States	OrthoCarolina, PA	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
OrthoCarolina Research Institute, Inc.	ConvaTec Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Patient pain and satisfaction (1-100 visual analog scale)		immediate postop, 5-7 days postop, 4 weeks postop	No