Status:
COMPLETED
Efficacy and Patient Satisfaction With AQUACEL® Ag Surgical Dressing Compared to Standard Surgical Dressing
Lead Sponsor:
OrthoCarolina Research Institute, Inc.
Collaborating Sponsors:
ConvaTec Inc.
Conditions:
Wound Healing
Eligibility:
All Genders
18-90 years
Phase:
NA
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 traditio...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01258270
Start Date
December 1 2010
End Date
May 1 2013
Last Update
June 10 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
OrthoCarolina, PA
Charlotte, North Carolina, United States, 28207