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OpenTrials
Completed

NCT Number: NCT01258270

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

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.

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Key information

Conditions

Wound Healing

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OrthoCarolina, PA

Charlotte, North Carolina, 28207, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. The incidence of postoperative severe skin reactions (defined as blisters) around the surgical incision site

    Time frame: 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 outcomes

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

    Time frame: immediate postop, 5-7 days postop, 4 weeks postop

Sponsors and collaborators

Lead sponsor

OrthoCarolina Research Institute, Inc.

Other

Collaborators

  • ConvaTec Inc.

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Dec 10, 2010
Registry last updated
Jun 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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