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

NCT ID: NCT01258270

Last Updated: 2013-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Wound Healing

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

(AQUACEL® Ag Surgical Dressing

Group Type ACTIVE_COMPARATOR

Postop Dressing

Intervention Type 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.

Standard island gauze and tape dressing

A standard island dressing consists of adhesive tape and gauze.

Group Type ACTIVE_COMPARATOR

Postop Dressing

Intervention Type PROCEDURE

A standard island dressing consists of adhesive tape and gauze.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Postop Dressing

A standard island dressing consists of adhesive tape and gauze.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ConvaTec Inc.

INDUSTRY

Sponsor Role collaborator

OrthoCarolina Research Institute, Inc.

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bryan D Springer, MD

Role: PRINCIPAL_INVESTIGATOR

OrthoCarolina, PA

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

OrthoCarolina, PA

Charlotte, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10-10-01A

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.