BurnsEarly Phase 1NCT03754218
Amnion Wound Covering for Enhanced Wound Healing
A Early Phase 1 study testing Amnion Membrane Powder and SOC Wound Covering in people with Burns and Wound of Skin, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this research study is to find our if human amnion membrane powder can be safely used as a covering for wounds and can improve the condition of skin graft donor sites. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Burns, Wound of Skin, Skin Wound
- What is being tested?
- Amnion Membrane Powder and SOC Wound Covering
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2019to 22 Nov 2023
- Phase
- Early 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject requires autologous primary skin graft with two donor sites in similar areas, each measuring at least 25 cm2 with the likely depth of 0.012 inches and separated by a 5 cm gap. It is preferable that the two sites be on right and left sides of the body, but it is not an exclusion if they must be on the same side.
- Eligible primary wound sites may be traumatic or chronic, and will be at least 50 cm2 (that will receive the donor graft) to allow assessment of two separate experimental donor sites of 25 cm2.
- The subject is between the ages of 18 and 85 years of age.
- The subject is willing to complete all follow-up evaluations required by the study protocol.
- The subject is to abstain from any other covering or treatment of the wound(s) for the duration of the study unless medically necessary.
- The subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
- The subject and/or guardian is able to read and understand instructions and give informed, voluntary, written consent.
- The subject is able and willing to follow the protocol requirements
Who cannot join
- The subject's primary wound site is less than 50 cm2The subject's primary wound site is not deemed appropriate for skin graft based upon the investigator's clinical experience
- The subject has a microbiologically proven pre-existing local or systemic bacterial infection.
- The subject has been receiving a systemic antibiotic for more than 48 hours prior to grafting.
- Unstable cardiac disorders within the past 6 months including angina, abnormal ECG, history of cardiac arrest, surgery and/or other interventional procedure.
- Hepatic disease or altered liver function as defined by ALT or AST value >3 times the upper limit of normal and/or T. Bilirubin >1.5 mg/dL at screening
- Renal disease or altered renal function as defined by serum creatinine > 2 mg/dL at screening, or end-stage renal disease.
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- Hemoglobin <10.0 or >19.0 g/dL
- Known coagulopathy or platelet disorder, or INR > 1.6 , PTT > 38 sec; PLT < 50,000 at screening
- The subject is known to have a pre-existing, chronic condition that, in the opinion of the Investigator, may interfere with wound healing including but not limited to: current malignancy, uncontrolled diabetes (HbA1c >8) or diabetic ulcers, autoimmune disease or other immunocompromised diseases, renal impairment or ESRD, liver disease, hematological
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Phase 1 Study of Human Amnion Membrane Powder for Enhanced Wound Healing
The purpose of this research study is to find our if human amnion membrane powder can be safely used as a covering for wounds and can improve the condition of skin graft donor sites. The amnion powder product is composed of "lyophilized" (freeze-dried), "gamma irradiation sterilized" (exposed to bacteria killing radiation) fragments of amniotic membrane.
Read the detailed description
Extensive burns and full thickness skin wounds can be devastating to patients, even when treated with our current standard of care. There are an estimated 500,000 burns treated in the United States each year. Moreover, in the military environment, soldiers who suffer from extensive burn injuries on the battlefield may benefit from rapid treatments that result in complete closure and protection of the wounds. As such, there is a need for mobile platform technologies that allow fast treatment at the site where the injury occurred, or at the very least at the forward operating sites. This safety investigation of a human amnion membrane powder product for wound healing is a with-in patient-controlled study, enrolling 10 subjects undergoing donor skin graft harvest. The single-center study will include patients undergoing donor skin harvest such that two regions, of at least 25 cm2 and separated by at least a 5 cm gap, of donor site wounds in comparable skin locations, are available for covering with the amnion membrane product and the current institutional standard of care (SOC) covering. The proposed sterilized product is composed of lyophilized, gamma-irradiated powder made from amniotic membrane for topical application with the purpose of enhanced wound healing.
The primary objective of the study is to evaluate the safety of a human amnion membrane product intended for enhanced wound healing. The secondary objective is efficacy as evidenced by complete wound closure relative to standard of care (SOC) treatment in a similar wound on the same subject at donor sites created for skin grafts at 14 days and 28 days postoperatively.
- Conditions
- Burns, Wound of Skin, Skin Wound
- Being tested
- Amnion Membrane Powder, SOC Wound Covering
- Keywords
- Human amnion membrane, Autologous skin graft, Scar Formation
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amnion Membrane PowderDrug
This sterilized product is composed of lyophilized, gamma-irradiated powder made from amniotic membrane for topical application with the purpose of enhanced wound healing.
SOC Wound CoveringProcedure or surgery
Institutional standard of care wound covering.
| Study group | Role | What they receive |
|---|---|---|
| Amnion membrane product treatment area | Experimental | The prepared amnion membrane powder will be directly applied to the prepared donor wound site (Site A). The wound will then be covered with the SOC dressing. Receives: Drug: Amnion Membrane Powder; Procedure: SOC Wound Covering |
| SOC Wound Covering treatment area | Active comparator | The donor wound site (Site B) will be covered per SOC (Standard of care). Receives: Procedure: SOC Wound Covering |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Donor Site Wound Closure
Wound closure for both amnion membrane product and SOC will be defined as skin re-epithelization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart.
Measured: Week 4
Secondary outcomes (4)
Incidence of Donor Site Wound Healing
Wound Healing for both amnion membrane product and SOC will be assessed clinically confirmed at two consecutive study visits 2 weeks apart.
Measured: week 12
Presence of infection
The presence of infection will be evaluated in accordance with guidelines derived from Cutting and Harding using standard clinical measures.
Measured: up to 26 Weeks
Vancouver Scar Assessment Scale
Scar formation will be evaluated the Vancouver Scar Assessment Scale.The scale is composed by the following Sub scales (minimum and maximum ranges in parenthesis): Pigmentation (0-2), Vascularity (0-3), Pliability (0-5), Height (0-3). Total score 0-13. Lower score denotes better outcomes for total range and subscales.
Measured: up to 26 Weeks
Presence of Dermatitis
Allergic Response to Human Amnion Membrane Product Covering will be assessed clinically by the presence of dermatitis.
Measured: Up to 26 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start1 Dec 2019
- Primary completion22 Nov 2023
- Study completion22 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Molnar, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754218
- Sponsor's protocol ID
- IRB00054157
- Status last verified
- May 2023
- First submitted
- 21 Nov 2018
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lesher AP, Curry RH, Evans J, Smith VA, Fitzgerald MT, Cina RA, Streck CJ, Hebra AV. Effectiveness of Biobrane for treatment of partial-thickness burns in children. J Pediatr Surg. 2011 Sep;46(9):1759-63. doi: 10.1016/j.jpedsurg.2011.03.070.
PubMed 21929986Rahmanian-Schwarz A, Beiderwieden A, Willkomm LM, Amr A, Schaller HE, Lotter O. A clinical evaluation of Biobrane((R)) and Suprathel((R)) in acute burns and reconstructive surgery. Burns. 2011 Dec;37(8):1343-8. doi: 10.1016/j.burns.2011.07.010. Epub 2011 Aug 17.
PubMed 21852044PIGEON J. Treatment of second-degree burns with amniotic membranes. Can Med Assoc J. 1960 Oct 15;83(16):844-5. No abstract available.
PubMed 13735672Faulk WP, Matthews R, Stevens PJ, Bennett JP, Burgos H, Hsi BL. Human amnion as an adjunct in wound healing. Lancet. 1980 May 31;1(8179):1156-8. doi: 10.1016/s0140-6736(80)91617-7.
PubMed 6155575Bose B. Burn wound dressing with human amniotic membrane. Ann R Coll Surg Engl. 1979 Nov;61(6):444-7.
PubMed 496235Koob TJ, Rennert R, Zabek N, Massee M, Lim JJ, Temenoff JS, Li WW, Gurtner G. Biological properties of dehydrated human amnion/chorion composite graft: implications for chronic wound healing. Int Wound J. 2013 Oct;10(5):493-500. doi: 10.1111/iwj.12140. Epub 2013 Aug 1.
PubMed 23902526Sawhney CP. Amniotic membrane as a biological dressing in the management of burns. Burns. 1989 Oct;15(5):339-42. doi: 10.1016/0305-4179(89)90015-6.
PubMed 2590408C. Ho, K. Tran, M. Hux, G. Sibbald, K. Campbell, Artificial skin grafts in chronic wound care: A meta-analysis of clinical efficacy and a review of cost-effectiveness, (2005).
Thapliyal, G.K., Kumar, V. and Gour, S., Amniotic Membrane: An Innovative Material for Repair and Regeneration in Oral and Maxillofacial region-A Review. Rama University Journal & Dental Sciences, 3(2) (2016) 1-6.
J.S. Davis, Skin transplantation, Johns Hopkins Hospital Reports 15 (1910) 307-96
Pachigolla G, Prasher P, Di Pascuale MA, McCulley JP, McHenry JG, Mootha VV. Evaluation of the role of ProKera in the management of ocular surface and orbital disorders. Eye Contact Lens. 2009 Jul;35(4):172-5. doi: 10.1097/ICL.0b013e3181a66a12.
PubMed 19474753Honavar SG, Bansal AK, Sangwan VS, Rao GN. Amniotic membrane transplantation for ocular surface reconstruction in Stevens-Johnson syndrome. Ophthalmology. 2000 May;107(5):975-9. doi: 10.1016/s0161-6420(00)00026-9.
PubMed 10811093Mohammadi AA, Seyed Jafari SM, Kiasat M, Tavakkolian AR, Imani MT, Ayaz M, Tolide-ie HR. Effect of fresh human amniotic membrane dressing on graft take in patients with chronic burn wounds compared with conventional methods. Burns. 2013 Mar;39(2):349-53. doi: 10.1016/j.burns.2012.07.010. Epub 2012 Aug 27.
PubMed 22951345Branski LK, Herndon DN, Celis MM, Norbury WB, Masters OE, Jeschke MG. Amnion in the treatment of pediatric partial-thickness facial burns. Burns. 2008 May;34(3):393-9. doi: 10.1016/j.burns.2007.06.007. Epub 2007 Oct 24.
PubMed 17920202Ravishanker R, Bath AS, Roy R. "Amnion Bank"--the use of long term glycerol preserved amniotic membranes in the management of superficial and superficial partial thickness burns. Burns. 2003 Jun;29(4):369-74. doi: 10.1016/s0305-4179(02)00304-2.
PubMed 12781617
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Human Amnion Membrane Powder for Enhanced Wound Healing
- ClinicalTrials.gov ID
- NCT03754218
- Acronym / sponsor ID
- IRB00054157
- Conditions
- Burns, Wound of Skin, Skin Wound
- Keywords
- Human amnion membrane, Autologous skin graft, Scar Formation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 22 Nov 2023 (actual)
- First posted
- 27 Nov 2018 (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.
The purpose of this research study is to find our if human amnion membrane powder can be safely used as a covering for wounds and can improve the condition of skin graft donor sites. The amnion powder product is composed of "lyophilized" (freeze-dried), "gamma irradiation sterilized" (exposed to bacteria killing radiation) fragments of amniotic membrane.
Detailed description
Extensive burns and full thickness skin wounds can be devastating to patients, even when treated with our current standard of care. There are an estimated 500,000 burns treated in the United States each year. Moreover, in the military environment, soldiers who suffer from extensive burn injuries on the battlefield may benefit from rapid treatments that result in complete closure and protection of the wounds. As such, there is a need for mobile platform technologies that allow fast treatment at the site where the injury occurred, or at the very least at the forward operating sites. This safety investigation of a human amnion membrane powder product for wound healing is a with-in patient-controlled study, enrolling 10 subjects undergoing donor skin graft harvest. The single-center study will include patients undergoing donor skin harvest such that two regions, of at least 25 cm2 and separated by at least a 5 cm gap, of donor site wounds in comparable skin locations, are available for covering with the amnion membrane product and the current institutional standard of care (SOC) covering. The proposed sterilized product is composed of lyophilized, gamma-irradiated powder made from amniotic membrane for topical application with the purpose of enhanced wound healing.
The primary objective of the study is to evaluate the safety of a human amnion membrane product intended for enhanced wound healing. The secondary objective is efficacy as evidenced by complete wound closure relative to standard of care (SOC) treatment in a similar wound on the same subject at donor sites created for skin grafts at 14 days and 28 days postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amnion membrane product treatment area | Experimental | Drug: Amnion Membrane Powder, Procedure: SOC Wound CoveringThe prepared amnion membrane powder will be directly applied to the prepared donor wound site (Site A). The wound will then be covered with the SOC dressing. |
| SOC Wound Covering treatment area | Active comparator | Procedure: SOC Wound CoveringThe donor wound site (Site B) will be covered per SOC (Standard of care). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The subject requires autologous primary skin graft with two donor sites in similar areas, each measuring at least 25 cm2 with the likely depth of 0.012 inches and separated by a 5 cm gap. It is preferable that the two sites be on right and left sides of the body, but it is not an exclusion if they must be on the same side.
- Eligible primary wound sites may be traumatic or chronic, and will be at least 50 cm2 (that will receive the donor graft) to allow assessment of two separate experimental donor sites of 25 cm2.
- The subject is between the ages of 18 and 85 years of age.
- The subject is willing to complete all follow-up evaluations required by the study protocol.
- The subject is to abstain from any other covering or treatment of the wound(s) for the duration of the study unless medically necessary.
Key exclusion criteria (9 listed)
- The subject's primary wound site is less than 50 cm2The subject's primary wound site is not deemed appropriate for skin graft based upon the investigator's clinical experience
- The subject has a microbiologically proven pre-existing local or systemic bacterial infection.
- The subject has been receiving a systemic antibiotic for more than 48 hours prior to grafting.
- Unstable cardiac disorders within the past 6 months including angina, abnormal ECG, history of cardiac arrest, surgery and/or other interventional procedure.
- Hepatic disease or altered liver function as defined by ALT or AST value >3 times the upper limit of normal and/or T. Bilirubin >1.5 mg/dL at screening
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 |
|---|---|---|
| Amnion Membrane PowderThis sterilized product is composed of lyophilized, gamma-irradiated powder made from amniotic membrane for topical application with the purpose of enhanced wound healing. | Drug | Amnion membrane product treatment area |
| SOC Wound CoveringInstitutional standard of care wound covering. | Procedure or surgery | Amnion membrane product treatment area, SOC Wound Covering treatment area |
Primary outcome
Incidence of Donor Site Wound Closure
Time frame: Week 4
Wound closure for both amnion membrane product and SOC will be defined as skin re-epithelization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart.
4 secondary outcomes
Incidence of Donor Site Wound Healing
Time frame: week 12
Presence of infection
Time frame: up to 26 Weeks
Vancouver Scar Assessment Scale
Time frame: up to 26 Weeks
Presence of Dermatitis
Time frame: Up to 26 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Background: PubMed 21929986Lesher AP, Curry RH, Evans J, Smith VA, Fitzgerald MT, Cina RA, Streck CJ, Hebra AV. Effectiveness of Biobrane for treatment of partial-thickness burns in children. J Pediatr Surg. 2011 Sep;46(9):1759-63. doi: 10.1016/j.jpedsurg.2011.03.070.
- Background: PubMed 21852044Rahmanian-Schwarz A, Beiderwieden A, Willkomm LM, Amr A, Schaller HE, Lotter O. A clinical evaluation of Biobrane((R)) and Suprathel((R)) in acute burns and reconstructive surgery. Burns. 2011 Dec;37(8):1343-8. doi: 10.1016/j.burns.2011.07.010. Epub 2011 Aug 17.
- Background: PubMed 13735672PIGEON J. Treatment of second-degree burns with amniotic membranes. Can Med Assoc J. 1960 Oct 15;83(16):844-5. No abstract available.
- Background: PubMed 6155575Faulk WP, Matthews R, Stevens PJ, Bennett JP, Burgos H, Hsi BL. Human amnion as an adjunct in wound healing. Lancet. 1980 May 31;1(8179):1156-8. doi: 10.1016/s0140-6736(80)91617-7.
- Background: PubMed 496235Bose B. Burn wound dressing with human amniotic membrane. Ann R Coll Surg Engl. 1979 Nov;61(6):444-7.
- Background: PubMed 23902526Koob TJ, Rennert R, Zabek N, Massee M, Lim JJ, Temenoff JS, Li WW, Gurtner G. Biological properties of dehydrated human amnion/chorion composite graft: implications for chronic wound healing. Int Wound J. 2013 Oct;10(5):493-500. doi: 10.1111/iwj.12140. Epub 2013 Aug 1.
- Background: PubMed 2590408Sawhney CP. Amniotic membrane as a biological dressing in the management of burns. Burns. 1989 Oct;15(5):339-42. doi: 10.1016/0305-4179(89)90015-6.
- BackgroundC. Ho, K. Tran, M. Hux, G. Sibbald, K. Campbell, Artificial skin grafts in chronic wound care: A meta-analysis of clinical efficacy and a review of cost-effectiveness, (2005).
- BackgroundThapliyal, G.K., Kumar, V. and Gour, S., Amniotic Membrane: An Innovative Material for Repair and Regeneration in Oral and Maxillofacial region-A Review. Rama University Journal & Dental Sciences, 3(2) (2016) 1-6.
- BackgroundJ.S. Davis, Skin transplantation, Johns Hopkins Hospital Reports 15 (1910) 307-96
- Background: PubMed 19474753Pachigolla G, Prasher P, Di Pascuale MA, McCulley JP, McHenry JG, Mootha VV. Evaluation of the role of ProKera in the management of ocular surface and orbital disorders. Eye Contact Lens. 2009 Jul;35(4):172-5. doi: 10.1097/ICL.0b013e3181a66a12.
- Background: PubMed 10811093Honavar SG, Bansal AK, Sangwan VS, Rao GN. Amniotic membrane transplantation for ocular surface reconstruction in Stevens-Johnson syndrome. Ophthalmology. 2000 May;107(5):975-9. doi: 10.1016/s0161-6420(00)00026-9.
- Individual participant dataSharing planned: No
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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.
Joseph Molnar, MD, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Amnion Membrane Powder and SOC Wound Covering in people with Burns and Wound of Skin, run by Wake Forest University Health Sciences 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 8 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: finished, as of the sponsor's last update on 9 Jan 2024. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Donor Site Wound Closure (time frame: Week 4). 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 NCT03754218, which also lists 40 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 2024.