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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01258270

Enrollment

300

Registered

2010-12-10

Start date

2010-12-31

Completion date

2013-05-31

Last updated

2013-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound Healing

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.

Interventions

PROCEDUREPostop 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026