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

NCT01258270 | Completed DMC

• 1 other identifier: 10-10-01A
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Healing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient pain and satisfaction (1-100 visual analog scale)

  immediate postop, 5-7 days postop, 4 weeks postop

Study Arms (2)

(AQUACEL® Ag Surgical Dressing

ACTIVE COMPARATOR

Procedure: Postop Dressing

Standard island gauze and tape dressing

ACTIVE COMPARATOR

A standard island dressing consists of adhesive tape and gauze.

Procedure: Postop Dressing

Interventions

Postop Dressing PROCEDURE

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.

(AQUACEL® Ag Surgical Dressing

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• OrthoCarolina Research Institute, Inc.: lead
• ConvaTec Inc.: collaborator

Study Sites (1)

OrthoCarolina, PA

Charlotte, North Carolina, 28207, United States

Location

Study Officials

• Bryan D Springer, MD

  OrthoCarolina, PA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2010
• First Posted: December 10, 2010
• Study Start: December 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 10, 2013

Record last verified: 2012-01

Locations

US (1)