WoundsNCT03285698
Comparing the Clinical Outcomes of DermACELL® With Integra® Bilayer Wound Matrix
A study testing DermACELL® and Integra® in people with Wounds and Chronic Wounds, run by Georgetown University at 1 site in United States.
Trial summary
Both DermACELL® and Integra® Bilayer Wound Matrix are indicated for deep soft tissue coverage and serve as a biological matrix for cellular migration. The current thinking about the utility of these products is to apply over the wound surface and wait until the graft is well vascularized (granular bed/neodermis). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Wounds, Chronic Wounds, Nonmalignant Condition
- What is being tested?
- DermACELL® and Integra®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2014to 1 Oct 2020
- 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
- male or female 18-90
- who have a complex soft tissue defect that extends below subcutaneous tissue (exposed fascia, ligament, tendon, muscle, or bone)
- wounds that are either acute or chronic (nonhealing wounds greater than 4 weeks but not greater than 2 years in duration)
- wounds not amendable to primary closure as deemed by the surgeon
- wounds that have been deemed by the surgeon that any residual infection has been or is being treated upon entry into the clinical trial
- requiring operative application of a dermoconductive agent
Show all 9Show fewer
- extremity wounds have adequate perfusion determined by: palpable pedal pulses, dopplerable pulses, ankle brachial index of >0.7, or transcutaneous oximetry of >0.5
- renally stable (i.e. CR<3.0, BUN>9.0, eGFR >60)
- is able to comply to clinical trial requirements
Who cannot join
- with a contraindication for the application of a xenograft or allograft
- untreated infection of soft tissue or bone
- untreated autoimmune connective tissue disorders
- body mass index of ≥ 50
- undergoing chemotherapy/radiation therapy
- malignancy
Show all 11Show fewer
- active liver disease (e.g. hepatitis A-G),
- previous wound care therapy that included any bioengineered alternative tissue or STSG 30 days prior to enrollment
- pregnancy
- enrolled in any other interventional clinical research trial
- unable or unwilling to comply with study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
About this study
Official title: A Randomized, Prospective Trial Comparing the Clinical Outcomes for DermACELL® Compared With Integra® Bilayer Wound Matrix
Both DermACELL® and Integra® Bilayer Wound Matrix are indicated for deep soft tissue coverage and serve as a biological matrix for cellular migration. The current thinking about the utility of these products is to apply over the wound surface and wait until the graft is well vascularized (granular bed/neodermis). At that point a split thickness skin graft can be applied over this area to cover and heal the wound. This study will determine whether human allograft or xenograft will create a durable neodermis that is more supportive of accepting of a split thickness skin graft. Patients who do not receive Split thickness skin grafts will be assigned to the second cohort for observation of healing rates.
Read the detailed description
This is a prospective, randomized, single site, clinical research trial comparing the clinical outcomes of DermACELL® compared with Integra® Bilayer Wound Matrix in dermal regeneration. A total of 100 subjects will be randomized into either the DermACELL® (n=50) or Integra® Bilayer Wound Matrix (n=50) treatment group. An interim analysis will be performed when both groups have enrolled 25 subjects. Subjects will receive either DermACELL® or Integra® Bilayer Wound Matrix in the operating room for coverage of deep soft tissue defects in the lower extremity. Subjects will then be followed in the outpatient clinic. Once the neodermis has been sufficiently generated, a split thickness skin graft (autograft or allograft) will be applied in the operating room. The split thickness skin graft application site will be then followed to observe viability.
- Conditions
- Wounds, Chronic Wounds, Nonmalignant Condition
- Being tested
- DermACELL®, Integra®
- Medical subject headings
- Wounds and Injuries, Precancerous Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermACELL®Device
DermACELL® is a bilayer wound matrix made out of human tissue and is applied to the wound in standard of care fashion.
Integra®Device
Integra® is a bilayer wound matrix made out of bovine tissue and is applied to the wound in standard of care fashion.
| Study group | Role | What they receive |
|---|---|---|
| Integra® | Other | Integra® is a bilayer wound matrix made out of bovine tissue. Receives: Device: Integra® |
| DermACELL® | Experimental | DermACELL® is a bilayer wound matrix made out of human tissue. Receives: Device: DermACELL® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time the wound bed takes to heal for split thickness skin graft application
Time (days) required for wound bed preparation (granular bed) for the application of a split thickness skin graft (autograft or allograft) after placement of DermACELL® as compared with Integra® Bilayer Wound Matrix.
Measured: 160 days
Secondary outcomes (1)
Percentage of subjects with complete split thickness skin graft take
The percent of subjects with complete split thickness skin graft (autograft or allograft) take utilizing DermACELL® as compared with Integra® Bilayer Wound Matrix 30 days after split thickness skin graft application.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start18 Apr 2014
- Primary completion31 Aug 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- LifeNet Health
- Responsible party
- Principal investigator, Christopher Attinger, M.D., Georgetown University
- Investigators
- Christopher Attinger, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285698
- Sponsor's protocol ID
- 2014-0061
- Status last verified
- Mar 2020
- First submitted
- 14 Sep 2017
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective Trial Comparing the Clinical Outcomes for DermACELL® Compared With Integra® Bilayer Wound Matrix
- ClinicalTrials.gov ID
- NCT03285698
- Acronym / sponsor ID
- 2014-0061
- Conditions
- Wounds, Chronic Wounds, Nonmalignant Condition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- LifeNet Health
- Study start
- 18 Apr 2014 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 18 Sep 2017 (actual)
- 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.
Both DermACELL® and Integra® Bilayer Wound Matrix are indicated for deep soft tissue coverage and serve as a biological matrix for cellular migration. The current thinking about the utility of these products is to apply over the wound surface and wait until the graft is well vascularized (granular bed/neodermis). At that point a split thickness skin graft can be applied over this area to cover and heal the wound. This study will determine whether human allograft or xenograft will create a durable neodermis that is more supportive of accepting of a split thickness skin graft. Patients who do not receive Split thickness skin grafts will be assigned to the second cohort for observation of healing rates.
Detailed description
This is a prospective, randomized, single site, clinical research trial comparing the clinical outcomes of DermACELL® compared with Integra® Bilayer Wound Matrix in dermal regeneration. A total of 100 subjects will be randomized into either the DermACELL® (n=50) or Integra® Bilayer Wound Matrix (n=50) treatment group. An interim analysis will be performed when both groups have enrolled 25 subjects. Subjects will receive either DermACELL® or Integra® Bilayer Wound Matrix in the operating room for coverage of deep soft tissue defects in the lower extremity. Subjects will then be followed in the outpatient clinic. Once the neodermis has been sufficiently generated, a split thickness skin graft (autograft or allograft) will be applied in the operating room. The split thickness skin graft application site will be then followed to observe viability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integra® | Other | Device: Integra®Integra® is a bilayer wound matrix made out of bovine tissue. |
| DermACELL® | Experimental | Device: DermACELL®DermACELL® is a bilayer wound matrix made out of human tissue. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- male or female 18-90
- who have a complex soft tissue defect that extends below subcutaneous tissue (exposed fascia, ligament, tendon, muscle, or bone)
- wounds that are either acute or chronic (nonhealing wounds greater than 4 weeks but not greater than 2 years in duration)
- wounds not amendable to primary closure as deemed by the surgeon
- wounds that have been deemed by the surgeon that any residual infection has been or is being treated upon entry into the clinical trial
Key exclusion criteria (11 listed)
- with a contraindication for the application of a xenograft or allograft
- untreated infection of soft tissue or bone
- untreated autoimmune connective tissue disorders
- body mass index of ≥ 50
- undergoing chemotherapy/radiation therapy
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 |
|---|---|---|
| DermACELL®DermACELL® is a bilayer wound matrix made out of human tissue and is applied to the wound in standard of care fashion. | Device | DermACELL® |
| Integra®Integra® is a bilayer wound matrix made out of bovine tissue and is applied to the wound in standard of care fashion. | Device | Integra® |
Primary outcome
Time the wound bed takes to heal for split thickness skin graft application
Time frame: 160 days
Time (days) required for wound bed preparation (granular bed) for the application of a split thickness skin graft (autograft or allograft) after placement of DermACELL® as compared with Integra® Bilayer Wound Matrix.
1 secondary outcome
Percentage of subjects with complete split thickness skin graft take
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
Related trials for Wounds
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
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.
Christopher Attinger, MD principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DermACELL® and Integra® in people with Wounds and Chronic Wounds, run by Georgetown University 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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 11 Mar 2020. 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?
Results are not available in the source record.
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?
Time the wound bed takes to heal for split thickness skin graft application (time frame: 160 days). 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 11 Mar 2020.