Wounds and InjuryNCT02469168
Epidermal Coverage of Traumatic Wound Injuries Via Use of Autologous Spray Skin Applied Over Bilayered Wound Matrix
A study testing Recell in people with Wounds and Injury, run by Rubin, J. Peter, MD at 1 site in United States.
Trial summary
The purpose of this investigation is to evaluate the safety, tolerability, preliminary and long-term effectiveness of utilizing the ReCell Autologous Cell Harvesting Device (ReCell) combined with widened split-thickness skin graft (STSG) mesh onto the dermal regenerate INTEGRA™ Meshed Bilayer Wound Matrix (MBWM) for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds and Injury
- What is being tested?
- Recell
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- • The subject is a male or female military healthcare beneficiary of any race or ethnicity, aged 18 years or older, who is being treated for a traumatic wound at WRNMMC
- The subject has soft tissue loss resulting from a traumatic mechanism such as an explosive blast (i.e. motar, rocket, IED), high-velocity shells (i.e. missile), an avulsion injury, gunshot wound motor vehicle accident and/or burn secondary to blast
- The subject's full-thickness or deep partial-thickness traumatic wound injury has been treated with INTEGRA™ MBWM as part of their standard of care
- The wound area is at least 200 cm2
- All areas of the study wound area are covered with INTEGRA™ MBWM and has fully engrafted - engrafting defined as the presence of a contiguous vascularized granulation layer indicated by the formation of a viable granulation layer (Note: there may be some areas of incomplete granulation at the INTEGRA™ MBWM application site, these areas will be excluded from the study wound area).
- The subject will comply with protocol requirements
- The subject will provide voluntary written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
Who cannot join
- Subjects will not be eligible for study participation if they meet any of the following criteria:
- The subject is pregnant and/or lactating (self-reported)
- The subject has evidence of the following lab value results:
- Hematocrit ≤ 20%
- INR > 1.8 second
- Creatinine (serum) > 2.0 mg/dL
Show all 18Show fewer
- Bilirubin Total (serum) within upper limit of normal (normal range 0.3-1.9 md/dL
- Liver function test (AST/ALT) greater than 2 times upper limit of normal as defined by the clinical laboratory defined normal ranges
- Albumin (serum) < 2.0 g/dL
- Platelets < 70 K/µL
- The subject's targeted traumatic wound injury is a craniofacial wound
- The subject's targeted traumatic wound injury is on a weight-bearing surface
- The subject's targeted traumatic wound is a full-thickness burn injury with visible eschar present (Note: Subjects with a traumatic wound of a burn nature secondary to an explosive blast injury resulting in significant soft tissue loss will NOT be excluded)
- The subject has active infection processes, that in the opinion of the investigator may compromise safety or study objectives
- The subject is known to have a pre-existing condition that may interfere with wound healing, e.g. malignancy, diabetes or autoimmune disease, immunocompromised blood borne diseases, has AIDS, is HIV or Hepatitis-A positive, or currently has a severe dermatological disorder (e.g. severe psoriasis, epidermolysis bullosa, pyoderma gangrenosum)
- The subject has other concurrent conditions that in the opinion of the investigator may compromise safety or study objectives
- The subject has a known hypersensitivity to Trypsin and/or Compound Sodium Lactate for Irrigation (Hartmann's) solution
- The subject cannot be compliant with study procedures and that, in the investigator's opinion, would interfere with the study objectives
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
Official title: Epidermal Coverage of Traumatic Wound Injuries Via Use of Autologous Skin Cell Harvesting Device in Combination With Widened Meshed Autograft Applied Over Bilayered Wound Matrix
The purpose of this investigation is to evaluate the safety, tolerability, preliminary and long-term effectiveness of utilizing the ReCell Autologous Cell Harvesting Device (ReCell) combined with widened split-thickness skin graft (STSG) mesh onto the dermal regenerate INTEGRA™ Meshed Bilayer Wound Matrix (MBWM) for healing of full-thickness wounds.
Read the detailed description
The goal of the study described herein is to determine the safety, tolerability, preliminary and long-term effectiveness of the use of the Recell device over a widened STSG mesh. It is hypothesized the ReCell cell suspension, in combination with INTEGRA™ MBWM, will improve upon the current standard of care. The potential for ReCell's promotion of healing in the interstices of the STSG mesh may close gaps that are potential points of failure during subsequent rehabilitation and return to physical activity. Within the current study, each participant will serve as his/her own control, allowing for comparison of ReCell treated (experimental) and non-ReCell treated (control) regions of the grafted wound. In the proposed study, each patient will serve as his/her own control. Due to the nature of the study, only patients whose wounds have been previously successfully treated with INTEGRA™ MBWM as part of their standard of care will qualify for participation.
Therefore, as part of enrollment eligibility criteria for this study, the identified study wound will first be treated with INTEGRA™ MBWM. The wound will then be allowed to heal for approximately two to four weeks, at which time a viable granulation layer will have developed thus allowing for next stage STSG grafting. The timing of the STSG application will be determined by clinician judgment based on the state of the granulation process, which varies between patients, but typically takes 2 to 4 weeks.
Approximately two to four weeks after INTEGRA™ MBWM treatment, the studied wound will be divided into a ReCell-treated area (over 1:5 meshed STSG) and a control area treated with 1:1.5 meshed STSG (no ReCell). In all cases, the ReCell region may be up to 320cm2 in size; the upper limit of application area for one ReCell kit, with a similarly sized control region. If the wound is larger than the combined ReCell and control regions (over 640cm2), the areas outside the study regions will be designated as non-study areas and treated according to standard of care. The same primary and secondary dressings will be used on ReCell-treated areas, control areas and donor sites. Once the study and control wounds are determined to have healed, standard local clinical practice will be followed.
Within-subject comparisons of the ReCell region and control region, in order to evaluate improvements associated with use of ReCell, a battery of measurements and evaluations will be made. These measurements are divided into three categories: safety and tolerability, preliminary effectiveness (acute healing process) and long-term effectiveness.
The safety of research participants is foremost. Therefore, efforts will be made to control risks to participants throughout the duration of their study participation. Wound healing time, donor site morbidity and histology will be assessed during an acute 6 week phase, with follow-up visits at Weeks 1, 2, 3, 4 and 6 post-treatment.
Subjects will continue in the study for long-term follow-up with clinic visits at Week 12 and 24 post-treatment. Healing of treated wound sites (A region and B region) and donor sites (STSG 1:5, STSG 1:1.5 and ReCell) will be assessed at each visit. Treated wounds will be considered healed when 95% or greater of the study area has re-epithelialized by Week 6 post-treatment. Donor sites will be considered healed when ≥95% of the donor site has re-epithelialized by Week 4 post-treatment. Aesthetic and functional outcomes of the treated areas will be assessed and documented. Subject satisfaction will also be assessed and documented at these two time points.
- Conditions
- Wounds and Injury
- Being tested
- Recell, Control
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RecellDevice
ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix
ControlProcedure or surgery
Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix
| Study group | Role | What they receive |
|---|---|---|
| ReCell | Experimental | Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B Receives: Device: Recell |
| Control | Active comparator | Allocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Event
Number of patients with a treatment-related adverse events requiring surgical intervention prior to Week 12 post-treatment and all serious adverse event (SAE) occurrences throughout the study
Measured: Prior to or at 12 weeks
Secondary outcomes (1)
Number of Participants With Confirmed Treatment Area Closure
Complete wound closure is defined as skin wound re-epithelialization at 95% or greater at treated wound site and donor sites confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a qualified clinician blinded to treatment assignment. The incidence of complete wound closure is hypothesized to be non-inferior for ReCell-treated areas as compared to control areas.
Measured: Prior to or at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Wounds and InjuryStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rubin, J. Peter, MD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh
- Responsible party
- Principal investigator, Leon Nesti, Walter Reed National Military Medical Center
- Investigators
- Leon J Nesti, PhD, Principal investigator, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469168
- Sponsor's protocol ID
- WRNNMC 391911-5
- Status last verified
- Jul 2018
- First submitted
- 3 Jun 2015
- Last updated
- 7 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Moiemen NS, Vlachou E, Staiano JJ, Thawy Y, Frame JD. Reconstructive surgery with Integra dermal regeneration template: histologic study, clinical evaluation, and current practice. Plast Reconstr Surg. 2006 Jun;117(7 Suppl):160S-174S. doi: 10.1097/01.prs.0000222609.40461.68.
PubMed 16799385Wood FM, Giles N, Stevenson A, Rea S, Fear M. Characterisation of the cell suspension harvested from the dermal epidermal junction using a ReCell(R) kit. Burns. 2012 Feb;38(1):44-51. doi: 10.1016/j.burns.2011.03.001. Epub 2011 Nov 12.
PubMed 22079538Waaijman T, Breetveld M, Ulrich M, Middelkoop E, Scheper RJ, Gibbs S. Use of a collagen-elastin matrix as transport carrier system to transfer proliferating epidermal cells to human dermis in vitro. Cell Transplant. 2010;19(10):1339-48. doi: 10.3727/096368910X507196. Epub 2010 Jun 3.
PubMed 20525428Wood FM, Stoner ML, Fowler BV, Fear MW. The use of a non-cultured autologous cell suspension and Integra dermal regeneration template to repair full-thickness skin wounds in a porcine model: a one-step process. Burns. 2007 Sep;33(6):693-700. doi: 10.1016/j.burns.2006.10.388. Epub 2007 May 7.
PubMed 17485177
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidermal Coverage of Traumatic Wound Injuries Via Use of Autologous Skin Cell Harvesting Device in Combination With Widened Meshed Autograft Applied Over Bilayered Wound Matrix
- ClinicalTrials.gov ID
- NCT02469168
- Acronym / sponsor ID
- WRNNMC 391911-5
- Conditions
- Wounds and Injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of funding
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Rubin, J. Peter, MDUniversity, hospital or other
- Collaborators
- University of Pittsburgh
- Study start
- Dec 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 11 Jun 2015 (estimated)
- Results
- Posted 3 Apr 2018
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 investigation is to evaluate the safety, tolerability, preliminary and long-term effectiveness of utilizing the ReCell Autologous Cell Harvesting Device (ReCell) combined with widened split-thickness skin graft (STSG) mesh onto the dermal regenerate INTEGRA™ Meshed Bilayer Wound Matrix (MBWM) for healing of full-thickness wounds.
Detailed description
The goal of the study described herein is to determine the safety, tolerability, preliminary and long-term effectiveness of the use of the Recell device over a widened STSG mesh. It is hypothesized the ReCell cell suspension, in combination with INTEGRA™ MBWM, will improve upon the current standard of care. The potential for ReCell's promotion of healing in the interstices of the STSG mesh may close gaps that are potential points of failure during subsequent rehabilitation and return to physical activity. Within the current study, each participant will serve as his/her own control, allowing for comparison of ReCell treated (experimental) and non-ReCell treated (control) regions of the grafted wound. In the proposed study, each patient will serve as his/her own control. Due to the nature of the study, only patients whose wounds have been previously successfully treated with INTEGRA™ MBWM as part of their standard of care will qualify for participation.
Therefore, as part of enrollment eligibility criteria for this study, the identified study wound will first be treated with INTEGRA™ MBWM. The wound will then be allowed to heal for approximately two to four weeks, at which time a viable granulation layer will have developed thus allowing for next stage STSG grafting. The timing of the STSG application will be determined by clinician judgment based on the state of the granulation process, which varies between patients, but typically takes 2 to 4 weeks.
Approximately two to four weeks after INTEGRA™ MBWM treatment, the studied wound will be divided into a ReCell-treated area (over 1:5 meshed STSG) and a control area treated with 1:1.5 meshed STSG (no ReCell). In all cases, the ReCell region may be up to 320cm2 in size; the upper limit of application area for one ReCell kit, with a similarly sized control region. If the wound is larger than the combined ReCell and control regions (over 640cm2), the areas outside the study regions will be designated as non-study areas and treated according to standard of care. The same primary and secondary dressings will be used on ReCell-treated areas, control areas and donor sites. Once the study and control wounds are determined to have healed, standard local clinical practice will be followed.
Within-subject comparisons of the ReCell region and control region, in order to evaluate improvements associated with use of ReCell, a battery of measurements and evaluations will be made. These measurements are divided into three categories: safety and tolerability, preliminary effectiveness (acute healing process) and long-term effectiveness.
The safety of research participants is foremost. Therefore, efforts will be made to control risks to participants throughout the duration of their study participation. Wound healing time, donor site morbidity and histology will be assessed during an acute 6 week phase, with follow-up visits at Weeks 1, 2, 3, 4 and 6 post-treatment.
Subjects will continue in the study for long-term follow-up with clinic visits at Week 12 and 24 post-treatment. Healing of treated wound sites (A region and B region) and donor sites (STSG 1:5, STSG 1:1.5 and ReCell) will be assessed at each visit. Treated wounds will be considered healed when 95% or greater of the study area has re-epithelialized by Week 6 post-treatment. Donor sites will be considered healed when ≥95% of the donor site has re-epithelialized by Week 4 post-treatment. Aesthetic and functional outcomes of the treated areas will be assessed and documented. Subject satisfaction will also be assessed and documented at these two time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ReCell | Experimental | Device: RecellAllocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B |
| Control | Active comparator | Procedure: ControlAllocation of treatments (Recell vs Control) to the INTEGRA™ Meshed Bilayer Wound Matrix (MBWM). Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • The subject is a male or female military healthcare beneficiary of any race or ethnicity, aged 18 years or older, who is being treated for a traumatic wound at WRNMMC
Key exclusion criteria (18 listed)
- Subjects will not be eligible for study participation if they meet any of the following criteria:
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 |
|---|---|---|
| RecellReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix | Device | ReCell |
| ControlStandard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix | Procedure or surgery | Control |
Primary outcome
Number of Participants With Adverse Event
Time frame: Prior to or at 12 weeks
Number of patients with a treatment-related adverse events requiring surgical intervention prior to Week 12 post-treatment and all serious adverse event (SAE) occurrences throughout the study
1 secondary outcome
Number of Participants With Confirmed Treatment Area Closure
Time frame: Prior to or at 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16799385Moiemen NS, Vlachou E, Staiano JJ, Thawy Y, Frame JD. Reconstructive surgery with Integra dermal regeneration template: histologic study, clinical evaluation, and current practice. Plast Reconstr Surg. 2006 Jun;117(7 Suppl):160S-174S. doi: 10.1097/01.prs.0000222609.40461.68.
- Background: PubMed 22079538Wood FM, Giles N, Stevenson A, Rea S, Fear M. Characterisation of the cell suspension harvested from the dermal epidermal junction using a ReCell(R) kit. Burns. 2012 Feb;38(1):44-51. doi: 10.1016/j.burns.2011.03.001. Epub 2011 Nov 12.
- Background: PubMed 20525428Waaijman T, Breetveld M, Ulrich M, Middelkoop E, Scheper RJ, Gibbs S. Use of a collagen-elastin matrix as transport carrier system to transfer proliferating epidermal cells to human dermis in vitro. Cell Transplant. 2010;19(10):1339-48. doi: 10.3727/096368910X507196. Epub 2010 Jun 3.
- Background: PubMed 17485177Wood FM, Stoner ML, Fowler BV, Fear MW. The use of a non-cultured autologous cell suspension and Integra dermal regeneration template to repair full-thickness skin wounds in a porcine model: a one-step process. Burns. 2007 Sep;33(6):693-700. doi: 10.1016/j.burns.2006.10.388. Epub 2007 May 7.
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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.
Leon J Nesti, PhD principal investigator
Walter Reed National Military Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recell in people with Wounds and Injury, run by Rubin, J. Peter, MD 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 7 inclusion and 18 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: stopped early, as of the sponsor's last update on 7 Aug 2018. 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?
Yes. Results are posted in the registry (first posted 3 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Adverse Event (time frame: Prior to or at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02469168, which also lists 4 linked publications.
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 7 Aug 2018.