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

This study has been completed.
Sponsor:
Collaborator:
ConvaTec Inc.
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01258270
First received: December 9, 2010
Last updated: June 6, 2013
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Wound Healing
 Procedure: Postop Dressing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Further study details as provided by OrthoCarolina Research Institute, Inc.:

Primary Outcome Measures:
  • The incidence of postoperative severe skin reactions (defined as blisters) around the surgical incision site [ Time Frame: 4 weeks postop ] [ Designated as safety issue: Yes ]
    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:
  • Patient pain and satisfaction (1-100 visual analog scale) [ Time Frame: immediate postop, 5-7 days postop, 4 weeks postop ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: December 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Active Comparator: Standard island gauze and tape dressing
A standard island dressing consists of adhesive tape and gauze.
 Procedure: Postop Dressing
A standard island dressing consists of adhesive tape and gauze.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258270

Locations
United States, North Carolina
OrthoCarolina, PA
Charlotte, North Carolina, United States, 28207
Sponsors and Collaborators
OrthoCarolina Research Institute, Inc.
ConvaTec Inc.
Investigators
Principal Investigator: Bryan D Springer, MD OrthoCarolina, PA
  More Information

No publications provided

Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01258270     History of Changes
Other Study ID Numbers: 10-10-01A
Study First Received: December 9, 2010
Last Updated: June 6, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on June 18, 2013