Acute BurnsPhase 1NCT01843686
Using Autologous Platelet Rich Plasma (PRP) Gel to Treat Deep 2nd and 3rd Degree Burns
A Phase 1 study testing Magellan® in people with Acute Burns, run by Arteriocyte, Inc. at 3 sites in United States.
Trial summary
This study will demonstrate the safety of the application of autologous platelet rich plasma (PRP) gel following excision and autologous skin grafting of acute deep 2nd and 3rd degree burns. The study will be a randomized, double-blinded controlled safety study. Read more about this study
- Who is it for?
- Ages 18 to 86 years
- Conditions the study is for
- Acute Burns
- What is being tested?
- Magellan®
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2013to Mar 2018
- Phase
- Phase 1
- 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 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained either the subject or the subject's legally acceptable representative prior to screening activities
- Male or female age ≥ 18 and ≤ 86 years of age
- Total burn wound measuring ≤ 20% TBSA to include a deep partial thickness/full thickness area requiring surgical excision and autologous split thickness skin grafts
- Hemoglobin HbA1c ≤7.5% (for patients with pre-existing diabetes mellitus)
- Able and willing to comply with the procedures required by the protocol. Patients may be managed as either inpatient or outpatient.
- If a female of childbearing potential, the subject must have a negative serum pregnancy test at screening
Show all 13Show fewer
- All participants, male and female, must use acceptable method(s) of birth control for the duration of the study
- Female subjects must be of non-childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or must be using adequate contraception (practicing one of the following methods of birth control):
- Total abstinence from sexual intercourse (minimum of one complete menstrual cycle before study entry),
- A partner who is physically unable to impregnate the subject (e.g., vasectomized)
- Contraceptives (oral, parenteral, or transdermal) for 3 consecutive months prior to the patient's cell concentrate administration,
- Intrauterine device (IUD)or,
- Double-barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream)
Who cannot join
- Conductive electrical burns and chemical burns
- Digits, head, genitalia, palms of hands, soles of feet, and face are excluded as test sites
- Burns that pose a risk to digits or limbs
- Test area with infection as determined clinically by the investigator prior to surgery
- Venous or arterial vascular disorder directly affecting a designated test area
- Known immune deficiency disorder, either congenital or acquired
Show all 19Show fewer
- Chronically malnourished as determined clinically by the investigator prior to surgery (Investigators are responsible for determining subjects are chronically malnourished during the screening process. Investigators should take into consideration the following parameters: medical history and physical appearance, the subject's body mass index, and any significant laboratory findings)
- Severe respiratory problems or concurrent head trauma at hospital admission, including inhalation injury requiring ventilatory support
- Any chronic condition requiring the use of systemic corticosteroids 30 days prior to study entry and anytime during the course of the study
- Any other acute or chronic concurrent medical condition(s) that in the investigator's opinion are a contraindication to skin grafting and study participation or limit the participant's life expectancy to < 6 months
- Known or suspected hypersensitivity to bovine protein
- Concurrent participation in another clinical trial in which an investigational agent is used. (Subjects must not have been enrolled in another clinical trial within 30 days of enrolling in this trial)
- Females who are pregnant or nursing or intend to become pregnant during the duration of the study
- Burn wounds that occur over joints
- Patients with the following abnormal laboratory test levels:
- Stage 4 or greater chronic kidney disease (eGFR < 30 mL/min)
- Hemoglobin < 10 g/dL
- Thrombocytopenia < 100,000 platelets/µL
- Serum albumin level <2.5 g/dL or > 30 g/dL at time of screening
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of California, Davis, Division of Burn Surgery
Sacramento, California, 95817
University of Utah Hospital
Salt Lake City, Utah, 84132
Medstar Health Research Institute
Washington D.C., District of Columbia, 20010
About this study
Official title: Use of Autologous Platelet Rich Plasma (PRP) Gel as an Adjunct to the Treatment of Deep 2nd and 3rd Degree Burns
This study will demonstrate the safety of the application of autologous platelet rich plasma (PRP) gel following excision and autologous skin grafting of acute deep 2nd and 3rd degree burns. The study will be a randomized, double-blinded controlled safety study. Investigators expect that the PRP will deliver improved hemostasis and growth factors at the wound site thus increasing the effectiveness of treatment at the wound site. This will lead to rapid production and delivery of an autologous therapy that should minimize additional morbidity to the patient.
Read the detailed description
The goal of this study is to demonstrate the safety of the application of autologous platelet rich plasma (PRP) gel following excision and autologous skin grafting of acute deep 2nd and 3rd degree burns. This treatment is intended to stimulate rapid healing and improve the outcome of standard of care treatments for burns common to active duty military personnel, and more broadly for treatment of all acute burns. The care is specific to excision and split thickness skin grafting in the context of this burn study. The study will enroll 42 patients receiving surgical management of acute 2nd and 3rd degree burns requiring excision and skin grafting. The patient's total body surface area burn injury should not exceed 20%. The study will be conducted for 12 months. This study will provide further information for the development of enhanced treatment of wound-deployable cellular therapy for advanced trauma care of burned warriors.
- Conditions
- Acute Burns
- Being tested
- Magellan®, Placebo Saline Gel and Usual and Customary Standard of Care
- Keywords
- Acute 2nd and 3rd Degree Burns, Autologous Platelet Rich Plasma (PRP), Skin Grafting, Magellan® System, Wounds
- 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.
Magellan®Device
Also called Autologous Platelet Rich Plasma
Autologous Platelet Rich Plasma Prepared Using the Magellan System
Placebo Saline Gel and Usual and Customary Standard of CareOther
| Study group | Role | What they receive |
|---|---|---|
| Autologous Platelet Rich Plasma (PRP) | Experimental | Magellan Autologous Platelet Separator used to extract Platelet Rich Plasma from autologous whole blood. PRP is mixed with calcified thrombin to create a gel, which is place on the excised wound bed prior to application of split thickness autograft. Receives: Device: Magellan® |
| Saline Gel, Standard of Care | Placebo comparator | Normlgel Saline is placed on the excised wound bed prior to application of split thickness autograft. Receives: Other: Placebo Saline Gel and Usual and Customary Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the safety of application of autologous platelet rich plasma (PRP) gel following excision of an acute deep 2nd and 3rd degree burn.
Examine that there is no increase in adverse events above what is seen with excision and split thickness autografting of deep 2nd and 3rd degree burns
Measured: 12 Months
Secondary outcomes (1)
Assessment of a composite of wound healing measurements
This treatment is intended to stimulate rapid healing and improve outcomes of standard of care burn treatments:
- Time to 100% healing and time to complete wound closure (skin re-epithelialization without drainage or dressing requirements confirmed at study visits wound remained closed for at least 14 days)
- Length of hospital stay
- Time for return to full activity clinical wound measurement with respect to wound surface area and need for reoperation.
- Monitoring improvement of scar appearance.
- Assessment of wound flora, dermal collagen and elastin content, and epithelialization using tissue markers.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startApr 2013
- Primary completionFeb 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Acute BurnsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arteriocyte, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Brian R. Barnes, PhD, Study director, Arteriocyte, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843686
- Sponsor's protocol ID
- ART-11-004
- Status last verified
- Jan 2018
- First submitted
- 25 Apr 2013
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bush J, Duncan JAL, Bond JS, Durani P, So K, Mason T, O'Kane S, Ferguson MWJ. Scar-improving efficacy of avotermin administered into the wound margins of skin incisions as evaluated by a randomized, double-blind, placebo-controlled, phase II clinical trial. Plast Reconstr Surg. 2010 Nov;126(5):1604-1615. doi: 10.1097/PRS.0b013e3181ef8e66.
PubMed 21042116Saad Setta H, Elshahat A, Elsherbiny K, Massoud K, Safe I. Platelet-rich plasma versus platelet-poor plasma in the management of chronic diabetic foot ulcers: a comparative study. Int Wound J. 2011 Jun;8(3):307-12. doi: 10.1111/j.1742-481X.2011.00797.x. Epub 2011 Apr 7.
PubMed 21470370Wieman TJ, Smiell JM, Su Y. Efficacy and safety of a topical gel formulation of recombinant human platelet-derived growth factor-BB (becaplermin) in patients with chronic neuropathic diabetic ulcers. A phase III randomized placebo-controlled double-blind study. Diabetes Care. 1998 May;21(5):822-7. doi: 10.2337/diacare.21.5.822.
PubMed 9589248Badiavas EV, Abedi M, Butmarc J, Falanga V, Quesenberry P. Participation of bone marrow derived cells in cutaneous wound healing. J Cell Physiol. 2003 Aug;196(2):245-50. doi: 10.1002/jcp.10260.
PubMed 12811816Milkiewicz M, Ispanovic E, Doyle JL, Haas TL. Regulators of angiogenesis and strategies for their therapeutic manipulation. Int J Biochem Cell Biol. 2006 Mar;38(3):333-57. doi: 10.1016/j.biocel.2005.10.006. Epub 2005 Nov 7.
PubMed 16309946Lee JA, Conejero JA, Mason JM, Parrett BM, Wear-Maggitti KD, Grant RT, Breitbart AS. Lentiviral transfection with the PDGF-B gene improves diabetic wound healing. Plast Reconstr Surg. 2005 Aug;116(2):532-8. doi: 10.1097/01.prs.0000172892.78964.49.
PubMed 16079687Renz EM, Cancio LC, Barillo DJ, White CE, Albrecht MC, Thompson CK, Ennis JL, Wanek SM, King JA, Chung KK, Wolf SE, Holcomb JB. Long range transport of war-related burn casualties. J Trauma. 2008 Feb;64(2 Suppl):S136-44; discussion S144-5. doi: 10.1097/TA.0b013e31816086c9.
PubMed 18376156Kalka C, Asahara T, Krone W, Isner JM. [Angiogenesis and vasculogenesis. Therapeutic strategies for stimulation of postnatal neovascularization]. Herz. 2000 Sep;25(6):611-22. doi: 10.1007/pl00001974. German.
PubMed 11076319Gomez R, Murray CK, Hospenthal DR, Cancio LC, Renz EM, Holcomb JB, Wade CE, Wolf SE. Causes of mortality by autopsy findings of combat casualties and civilian patients admitted to a burn unit. J Am Coll Surg. 2009 Mar;208(3):348-54. doi: 10.1016/j.jamcollsurg.2008.11.012. Epub 2009 Jan 21.
PubMed 19317995Schwacha MG, Nickel E, Daniel T. Burn injury-induced alterations in wound inflammation and healing are associated with suppressed hypoxia inducible factor-1alpha expression. Mol Med. 2008 Sep-Oct;14(9-10):628-33. doi: 10.2119/2008-00069.Schwacha.
PubMed 18615157Church D, Elsayed S, Reid O, Winston B, Lindsay R. Burn wound infections. Clin Microbiol Rev. 2006 Apr;19(2):403-34. doi: 10.1128/CMR.19.2.403-434.2006.
PubMed 16614255Kazakos K, Lyras DN, Verettas D, Tilkeridis K, Tryfonidis M. The use of autologous PRP gel as an aid in the management of acute trauma wounds. Injury. 2009 Aug;40(8):801-5. doi: 10.1016/j.injury.2008.05.002. Epub 2008 Aug 13.
PubMed 18703188Marquez De Aracena Del Cid R, Montero De Espinosa Escoriaza I. Subconjunctival application of regenerative factor-rich plasma for the treatment of ocular alkali burns. Eur J Ophthalmol. 2009 Nov-Dec;19(6):909-15. doi: 10.1177/112067210901900603.
PubMed 19882589Pallua N, Wolter T, Markowicz M. Platelet-rich plasma in burns. Burns. 2010 Feb;36(1):4-8. doi: 10.1016/j.burns.2009.05.002. Epub 2009 Jun 21.
PubMed 19541423Asahara T, Takahashi T, Masuda H, Kalka C, Chen D, Iwaguro H, Inai Y, Silver M, Isner JM. VEGF contributes to postnatal neovascularization by mobilizing bone marrow-derived endothelial progenitor cells. EMBO J. 1999 Jul 15;18(14):3964-72. doi: 10.1093/emboj/18.14.3964.
PubMed 10406801
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Autologous Platelet Rich Plasma (PRP) Gel as an Adjunct to the Treatment of Deep 2nd and 3rd Degree Burns
- ClinicalTrials.gov ID
- NCT01843686
- Acronym / sponsor ID
- ART-11-004
- Conditions
- Acute Burns
- Keywords
- Acute 2nd and 3rd Degree Burns, Autologous Platelet Rich Plasma (PRP), Skin Grafting, Magellan® System, Wounds
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Arteriocyte, Inc.Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- Apr 2013 (actual)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 1 May 2013 (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.
This study will demonstrate the safety of the application of autologous platelet rich plasma (PRP) gel following excision and autologous skin grafting of acute deep 2nd and 3rd degree burns. The study will be a randomized, double-blinded controlled safety study. Investigators expect that the PRP will deliver improved hemostasis and growth factors at the wound site thus increasing the effectiveness of treatment at the wound site. This will lead to rapid production and delivery of an autologous therapy that should minimize additional morbidity to the patient.
Detailed description
The goal of this study is to demonstrate the safety of the application of autologous platelet rich plasma (PRP) gel following excision and autologous skin grafting of acute deep 2nd and 3rd degree burns. This treatment is intended to stimulate rapid healing and improve the outcome of standard of care treatments for burns common to active duty military personnel, and more broadly for treatment of all acute burns. The care is specific to excision and split thickness skin grafting in the context of this burn study. The study will enroll 42 patients receiving surgical management of acute 2nd and 3rd degree burns requiring excision and skin grafting. The patient's total body surface area burn injury should not exceed 20%. The study will be conducted for 12 months. This study will provide further information for the development of enhanced treatment of wound-deployable cellular therapy for advanced trauma care of burned warriors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous Platelet Rich Plasma (PRP) | Experimental | Device: Magellan®Magellan Autologous Platelet Separator used to extract Platelet Rich Plasma from autologous whole blood. PRP is mixed with calcified thrombin to create a gel, which is place on the excised wound bed prior to application of split thickness autograft. |
| Saline Gel, Standard of Care | Placebo comparator | Other: Placebo Saline Gel and Usual and Customary Standard of CareNormlgel Saline is placed on the excised wound bed prior to application of split thickness autograft. |
Who may qualify
- Ages
- 18 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Written informed consent obtained either the subject or the subject's legally acceptable representative prior to screening activities
- Male or female age ≥ 18 and ≤ 86 years of age
- Total burn wound measuring ≤ 20% TBSA to include a deep partial thickness/full thickness area requiring surgical excision and autologous split thickness skin grafts
- Hemoglobin HbA1c ≤7.5% (for patients with pre-existing diabetes mellitus)
- Able and willing to comply with the procedures required by the protocol. Patients may be managed as either inpatient or outpatient.
Key exclusion criteria (19 listed)
- Conductive electrical burns and chemical burns
- Digits, head, genitalia, palms of hands, soles of feet, and face are excluded as test sites
- Burns that pose a risk to digits or limbs
- Test area with infection as determined clinically by the investigator prior to surgery
- Venous or arterial vascular disorder directly affecting a designated test 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 |
|---|---|---|
| Magellan®Also: Autologous Platelet Rich PlasmaAutologous Platelet Rich Plasma Prepared Using the Magellan System | Device | Autologous Platelet Rich Plasma (PRP) |
| Placebo Saline Gel and Usual and Customary Standard of Care | Other | Saline Gel, Standard of Care |
Primary outcome
Demonstrate the safety of application of autologous platelet rich plasma (PRP) gel following excision of an acute deep 2nd and 3rd degree burn.
Time frame: 12 Months
Examine that there is no increase in adverse events above what is seen with excision and split thickness autografting of deep 2nd and 3rd degree burns
1 secondary outcome
Assessment of a composite of wound healing measurements
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Background: PubMed 21042116Bush J, Duncan JAL, Bond JS, Durani P, So K, Mason T, O'Kane S, Ferguson MWJ. Scar-improving efficacy of avotermin administered into the wound margins of skin incisions as evaluated by a randomized, double-blind, placebo-controlled, phase II clinical trial. Plast Reconstr Surg. 2010 Nov;126(5):1604-1615. doi: 10.1097/PRS.0b013e3181ef8e66.
- Background: PubMed 21470370Saad Setta H, Elshahat A, Elsherbiny K, Massoud K, Safe I. Platelet-rich plasma versus platelet-poor plasma in the management of chronic diabetic foot ulcers: a comparative study. Int Wound J. 2011 Jun;8(3):307-12. doi: 10.1111/j.1742-481X.2011.00797.x. Epub 2011 Apr 7.
- Background: PubMed 9589248Wieman TJ, Smiell JM, Su Y. Efficacy and safety of a topical gel formulation of recombinant human platelet-derived growth factor-BB (becaplermin) in patients with chronic neuropathic diabetic ulcers. A phase III randomized placebo-controlled double-blind study. Diabetes Care. 1998 May;21(5):822-7. doi: 10.2337/diacare.21.5.822.
- Background: PubMed 12811816Badiavas EV, Abedi M, Butmarc J, Falanga V, Quesenberry P. Participation of bone marrow derived cells in cutaneous wound healing. J Cell Physiol. 2003 Aug;196(2):245-50. doi: 10.1002/jcp.10260.
- Background: PubMed 16309946Milkiewicz M, Ispanovic E, Doyle JL, Haas TL. Regulators of angiogenesis and strategies for their therapeutic manipulation. Int J Biochem Cell Biol. 2006 Mar;38(3):333-57. doi: 10.1016/j.biocel.2005.10.006. Epub 2005 Nov 7.
- Background: PubMed 16079687Lee JA, Conejero JA, Mason JM, Parrett BM, Wear-Maggitti KD, Grant RT, Breitbart AS. Lentiviral transfection with the PDGF-B gene improves diabetic wound healing. Plast Reconstr Surg. 2005 Aug;116(2):532-8. doi: 10.1097/01.prs.0000172892.78964.49.
- Background: PubMed 18376156Renz EM, Cancio LC, Barillo DJ, White CE, Albrecht MC, Thompson CK, Ennis JL, Wanek SM, King JA, Chung KK, Wolf SE, Holcomb JB. Long range transport of war-related burn casualties. J Trauma. 2008 Feb;64(2 Suppl):S136-44; discussion S144-5. doi: 10.1097/TA.0b013e31816086c9.
- Background: PubMed 11076319Kalka C, Asahara T, Krone W, Isner JM. [Angiogenesis and vasculogenesis. Therapeutic strategies for stimulation of postnatal neovascularization]. Herz. 2000 Sep;25(6):611-22. doi: 10.1007/pl00001974. German.
- Background: PubMed 19317995Gomez R, Murray CK, Hospenthal DR, Cancio LC, Renz EM, Holcomb JB, Wade CE, Wolf SE. Causes of mortality by autopsy findings of combat casualties and civilian patients admitted to a burn unit. J Am Coll Surg. 2009 Mar;208(3):348-54. doi: 10.1016/j.jamcollsurg.2008.11.012. Epub 2009 Jan 21.
- Background: PubMed 18615157Schwacha MG, Nickel E, Daniel T. Burn injury-induced alterations in wound inflammation and healing are associated with suppressed hypoxia inducible factor-1alpha expression. Mol Med. 2008 Sep-Oct;14(9-10):628-33. doi: 10.2119/2008-00069.Schwacha.
- Background: PubMed 16614255Church D, Elsayed S, Reid O, Winston B, Lindsay R. Burn wound infections. Clin Microbiol Rev. 2006 Apr;19(2):403-34. doi: 10.1128/CMR.19.2.403-434.2006.
- Background: PubMed 18703188Kazakos K, Lyras DN, Verettas D, Tilkeridis K, Tryfonidis M. The use of autologous PRP gel as an aid in the management of acute trauma wounds. Injury. 2009 Aug;40(8):801-5. doi: 10.1016/j.injury.2008.05.002. Epub 2008 Aug 13.
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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.
Brian R. Barnes, PhD study director
Arteriocyte, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Magellan® in people with Acute Burns, run by Arteriocyte, Inc. at 3 sites 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 13 inclusion and 19 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 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Demonstrate the safety of application of autologous platelet rich plasma (PRP) gel following excision of an acute deep 2nd and 3rd degree burn. (time frame: 12 Months). 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 NCT01843686, which also lists 15 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 9 Jan 2018.