BandagesPhase 4HyalomatrixNCT02363543
Comparison of Hyalomatrix and Integra Wound Matrix on Burn Wounds
A Phase 4 study testing Hyalomatrix and Integra in people with Bandages, run by Medline Industries.
Trial summary
The purpose of this randomized, comparative study is to determine whether Hyalomatrix is as effective as IntegraTM Meshed Bilayer Wound Matrix when used in subjects who receive concurrent treatments with both products on their first and/or second degree burns located on both hands. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bandages
- What is being tested?
- Hyalomatrix and Integra
- 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 2016to Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written consent must be obtained
- First and/or second degree burns on both hands
- Subject must be enrolled within 48 hours of the injury occurrence.
Who cannot join
- Subject is breastfeeding, pregnant, or has intentions of becoming pregnant during the course of their study participation.
- Subject has a prognosis that indicates unlikely survival past the study period.
- Subject's diagnosis indicates third degree burns.
- Subject suffers from burns sustained as a result of an electrical/chemical injury or by frostbite.
- Subject suffers from any inhalation-related burn trauma.
- Subject suffers from ongoing bone fractures.
Show all 9Show fewer
- Subject has a known sensitivity to materials containing silicone, hyaluronan, bovine collagen, or chondroitin and/or derivatives of these products.
- Subject has received any treatment prior to study enrollment that may, in the opinion of the Investigator, affect the outcome of the study.
- Subject suffers from a medical condition that may impede wound healing, above any beyond that which would typically be expected.
About this study
The purpose of this randomized, comparative study is to determine whether Hyalomatrix is as effective as IntegraTM Meshed Bilayer Wound Matrix when used in subjects who receive concurrent treatments with both products on their first and/or second degree burns located on both hands.
- Conditions
- Bandages
- Being tested
- Hyalomatrix, Integra
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyalomatrixDevice
IntegraDevice
| Study group | Role | What they receive |
|---|---|---|
| Hyalomatrix | Active comparator | Sterile, single use, flexible, and conformable wound dressing comprised of a derivative of hyaluronic acid which acts as a three dimensional regenerative matrix. Receives: Device: Hyalomatrix |
| Integra | Active comparator | Sterile, single use, wound care dressing comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan Receives: Device: Integra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Infection Rate
Measured: Up to 21 days
Number of days required for wound healing
Measured: Up to 21 days
Secondary outcomes (2)
Range of Motion Scores
Analysis of Range of Motion Scores
Measured: Up to 21 days
Physician Scores on Products Ease of Use
Analysis of physician scores
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 posted16 Feb 2015 (estimated)
- Study startFeb 2016
- Primary completionMay 2016 (estimated)
- Study completionJul 2016 (estimated)
Why it stopped: Sponsor decision to not to proceed
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
- NCT02363543
- Sponsor's protocol ID
- R14-090
- Acronym
- Hyalomatrix
- Status last verified
- Aug 2017
- First submitted
- 28 Jan 2015
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hyalomatrix and Integra Wound Matrix on Burn Wounds
- ClinicalTrials.gov ID
- NCT02363543
- Acronym / sponsor ID
- Hyalomatrix / R14-090
- Conditions
- Bandages
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision to not to proceed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medline IndustriesIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- May 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 16 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 randomized, comparative study is to determine whether Hyalomatrix is as effective as IntegraTM Meshed Bilayer Wound Matrix when used in subjects who receive concurrent treatments with both products on their first and/or second degree burns located on both hands.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyalomatrix | Active comparator | Device: HyalomatrixSterile, single use, flexible, and conformable wound dressing comprised of a derivative of hyaluronic acid which acts as a three dimensional regenerative matrix. |
| Integra | Active comparator | Device: IntegraSterile, single use, wound care dressing comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written consent must be obtained
- First and/or second degree burns on both hands
- Subject must be enrolled within 48 hours of the injury occurrence.
Key exclusion criteria (9 listed)
- Subject is breastfeeding, pregnant, or has intentions of becoming pregnant during the course of their study participation.
- Subject has a prognosis that indicates unlikely survival past the study period.
- Subject's diagnosis indicates third degree burns.
- Subject suffers from burns sustained as a result of an electrical/chemical injury or by frostbite.
- Subject suffers from any inhalation-related burn trauma.
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 |
|---|---|---|
| Hyalomatrix | Device | Hyalomatrix |
| Integra | Device | Integra |
Primary outcome
Wound Infection Rate
Time frame: Up to 21 days
Number of days required for wound healing
Time frame: Up to 21 days
2 secondary outcomes
Range of Motion Scores
Time frame: Up to 21 days
Physician Scores on Products Ease of Use
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 30 Aug 2017.
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 Hyalomatrix and Integra 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 3 inclusion and 9 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 30 Aug 2017. 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 Rate (time frame: Up to 21 days). 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 30 Aug 2017.