Wound HealingNCT01258270
Efficacy and Patient Satisfaction With AQUACEL® Ag Surgical Dressing Compared to Standard Surgical Dressing
A study testing Postop Dressing in people with Wound Healing, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Wound Healing
- What is being tested?
- Postop Dressing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- Postop Dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postop DressingProcedure or surgery
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.
Postop DressingProcedure or surgery
A standard island dressing consists of adhesive tape and gauze.
| Study group | Role | What they receive |
|---|---|---|
| (AQUACEL® Ag Surgical Dressing | Active comparator | Not described Receives: Procedure: Postop Dressing |
| Standard island gauze and tape dressing | Active comparator | A standard island dressing consists of adhesive tape and gauze. Receives: Procedure: Postop Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks postop
Secondary outcomes (1)
Patient pain and satisfaction (1-100 visual analog scale)
Measured: immediate postop, 5-7 days postop, 4 weeks postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrthoCarolina Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- ConvaTec Inc.
- Responsible party
- Sponsor
- Investigators
- Bryan D Springer, MD, Principal investigator, OrthoCarolina, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258270
- Sponsor's protocol ID
- 10-10-01A
- Status last verified
- Jan 2012
- First submitted
- 9 Dec 2010
- Last updated
- 10 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01258270
- Acronym / sponsor ID
- 10-10-01A
- Conditions
- Wound Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- OrthoCarolina Research Institute, Inc.University, hospital or other
- Collaborators
- ConvaTec Inc.
- Study start
- Dec 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 10 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (AQUACEL® Ag Surgical Dressing | Active comparator | Procedure: Postop Dressing |
| Standard island gauze and tape dressing | Active comparator | Procedure: Postop DressingA standard island dressing consists of adhesive tape and gauze. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postop DressingThe 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. | Procedure or surgery | (AQUACEL® Ag Surgical Dressing |
| Postop DressingA standard island dressing consists of adhesive tape and gauze. | Procedure or surgery | Standard island gauze and tape dressing |
Primary outcome
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.
1 secondary outcome
Patient pain and satisfaction (1-100 visual analog scale)
Time frame: immediate postop, 5-7 days postop, 4 weeks postop
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan D Springer, MD principal investigator
OrthoCarolina, PA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postop Dressing in people with Wound Healing, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative severe skin reactions (defined as blisters) around the surgical incision site (time frame: 4 weeks postop). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2013.