BandagesPhase 4NCT02353507
Comparison of Chitosan and Carboxymethylcellulose Silver Dressings on Burn Wounds in Pediatric and Adult Subjects
A Phase 4 study testing Opticell Ag+ and Aquacel Ag+ in people with Bandages, run by Medline Industries.
Trial summary
The purpose of this prospective, randomized, comparative multi-center study is to compare the effective management of two silver-based dressings in managing exudative wounds in first and second degree burns. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Bandages
- What is being tested?
- Opticell Ag+ and Aquacel Ag+
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Apr 2016
- Phase
- Phase 4
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Inpatient status at the site
- Written consent obtained from the subject
- Burn injury must have been incurred within 36 hours prior to enrollment.
- Burn injury must be of superficial partial thickness, mid-dermal partial thickness, or a combination of the two depths
- Burn injury must exceed 3% total body surface area.
Who cannot join
- Subject is pregnant.
- Bone fractures.
- Inhalation-related trauma.
- Sensitive and/or allergic to materials containing silver.
- Burn injury exceeds 40% total body surface area.
- Burn injury diagnosis indicates deep partial or full thickness wounds.
- Burn a result of electrical/chemical injury or frostbite.
- An active agent, such as a topical antimicrobial or an enzymatic debriding agent was previously used to treat the burn injury in question.
About this study
Official title: A Multi-Center, Randomized, Comparison Study of a Chitosan (Opticell Ag+) Silver Dressing and a Sodium Carboxymethylcellulose (Aquacel® Ag+) Silver Dressing on Burn Wounds in Pediatrics and Adults Subjects
The purpose of this prospective, randomized, comparative multi-center study is to compare the effective management of two silver-based dressings in managing exudative wounds in first and second degree burns.
- Conditions
- Bandages
- Being tested
- Opticell Ag+, Aquacel Ag+
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opticell Ag+Device
Aquacel Ag+Device
| Study group | Role | What they receive |
|---|---|---|
| Opticell Ag+ | Active comparator | Absorbent, antibacterial, barrier dressing Receives: Device: Opticell Ag+ |
| Aquacel Ag+ | Active comparator | Absorbent, antibacterial, barrier dressing Receives: Device: Aquacel Ag+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Infection Rates
Measured: Up to 21 days of use
Days required for wound healing
Measured: Up to 21 days of use
Secondary outcomes (1)
Pain Levels during Dressing Removal
Categorical scale of pain reported by Subject
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BandagesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medline Industries
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353507
- Sponsor's protocol ID
- R14-054
- Status last verified
- Feb 2015
- First submitted
- 28 Jan 2015
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Comparison Study of a Chitosan (Opticell Ag+) Silver Dressing and a Sodium Carboxymethylcellulose (Aquacel® Ag+) Silver Dressing on Burn Wounds in Pediatrics and Adults Subjects
- ClinicalTrials.gov ID
- NCT02353507
- Acronym / sponsor ID
- R14-054
- Conditions
- Bandages
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medline IndustriesIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 2 Feb 2015 (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 purpose of this prospective, randomized, comparative multi-center study is to compare the effective management of two silver-based dressings in managing exudative wounds in first and second degree burns.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opticell Ag+ | Active comparator | Device: Opticell Ag+Absorbent, antibacterial, barrier dressing |
| Aquacel Ag+ | Active comparator | Device: Aquacel Ag+Absorbent, antibacterial, barrier dressing |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Inpatient status at the site
- Written consent obtained from the subject
- Burn injury must have been incurred within 36 hours prior to enrollment.
- Burn injury must be of superficial partial thickness, mid-dermal partial thickness, or a combination of the two depths
- Burn injury must exceed 3% total body surface area.
Key exclusion criteria (8 listed)
- Subject is pregnant.
- Bone fractures.
- Inhalation-related trauma.
- Sensitive and/or allergic to materials containing silver.
- Burn injury exceeds 40% total body surface area.
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 |
|---|---|---|
| Opticell Ag+ | Device | Opticell Ag+ |
| Aquacel Ag+ | Device | Aquacel Ag+ |
Primary outcome
Wound Infection Rates
Time frame: Up to 21 days of use
Days required for wound healing
Time frame: Up to 21 days of use
1 secondary outcome
Pain Levels during Dressing Removal
Time frame: Up to 21 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
Related trials for Bandages
Not yet recruiting
Cohesive Bandage Fixation of Pulse Oximeter Probes and Skin Condition in Preterm Neonates
Skin Injury, Premature Birth
Recruiting
Lower Extremity Graft Study (LEGS): A Multicentre Randomised Controlled Trial of Negative Pressure Wound Therapy Versus Conventional Dressings for Split-thickness Skin Grafts After Lower Leg Skin Tumour Excision
Skin Transplantation, Skin Grafting
Recruiting
Diabetic Foot Ulcers: Shorter Treatment Period Using Custom Felt Relief?
Diabetic Foot Ulcer
Not yet recruiting
Comparison of Ketorolac Tromethamine 0.5%-Soaked Bandage Contact Lenses Versus Non-Medicated Bandage Contact Lenses on Postoperative Pain Control After Photorefractive Keratectomy
Refraction Error, Photorefractive Keratectomy
Not yet recruiting
Smart Bandage With Telemonitoring vs Standard Care for Venous Leg Ulcer: Randomized Trial
Venous Leg Ulcer (VLU), Chronic Wound
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Opticell Ag+ and Aquacel Ag+ in people with Bandages, run by Medline Industries.
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 8 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: withdrawn, as of the sponsor's last update on 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Wound Infection Rates (time frame: Up to 21 days of use). The study lists 2 primary outcomes in all. 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 27 Apr 2016.