<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03754218</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00054157</org_study_id>
    <nct_id>NCT03754218</nct_id>
  </id_info>
  <brief_title>Amnion Wound Covering for Enhanced Wound Healing</brief_title>
  <official_title>Phase 1 Study of Human Amnion Membrane Powder for Enhanced Wound Healing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to find our if human amnion membrane powder can be&#xD;
      safely used as a covering for wounds and can improve the condition of skin graft donor sites.&#xD;
      The amnion powder product is composed of &quot;lyophilized&quot; (freeze-dried), &quot;gamma irradiation&#xD;
      sterilized&quot; (exposed to bacteria killing radiation) fragments of amniotic membrane.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Extensive burns and full thickness skin wounds can be devastating to patients, even when&#xD;
      treated with our current standard of care. There are an estimated 500,000 burns treated in&#xD;
      the United States each year. Moreover, in the military environment, soldiers who suffer from&#xD;
      extensive burn injuries on the battlefield may benefit from rapid treatments that result in&#xD;
      complete closure and protection of the wounds. As such, there is a need for mobile platform&#xD;
      technologies that allow fast treatment at the site where the injury occurred, or at the very&#xD;
      least at the forward operating sites. This safety investigation of a human amnion membrane&#xD;
      powder product for wound healing is a with-in patient-controlled study, enrolling 10 subjects&#xD;
      undergoing donor skin graft harvest. The single-center study will include patients undergoing&#xD;
      donor skin harvest such that two regions, of at least 25 cm2 and separated by at least a 5 cm&#xD;
      gap, of donor site wounds in comparable skin locations, are available for covering with the&#xD;
      amnion membrane product and the current institutional standard of care (SOC) covering. The&#xD;
      proposed sterilized product is composed of lyophilized, gamma-irradiated powder made from&#xD;
      amniotic membrane for topical application with the purpose of enhanced wound healing.&#xD;
&#xD;
      The primary objective of the study is to evaluate the safety of a human amnion membrane&#xD;
      product intended for enhanced wound healing. The secondary objective is efficacy as evidenced&#xD;
      by complete wound closure relative to standard of care (SOC) treatment in a similar wound on&#xD;
      the same subject at donor sites created for skin grafts at 14 days and 28 days&#xD;
      postoperatively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2019</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Donor Site Wound Closure</measure>
    <time_frame>Week 4</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Donor Site Wound Healing</measure>
    <time_frame>week 12</time_frame>
    <description>Wound Healing for both amnion membrane product and SOC will be assessed clinically confirmed at two consecutive study visits 2 weeks apart.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of infection</measure>
    <time_frame>up to 26 Weeks</time_frame>
    <description>The presence of infection will be evaluated in accordance with guidelines derived from Cutting and Harding using standard clinical measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vancouver Scar Assessment Scale</measure>
    <time_frame>up to 26 Weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of Dermatitis</measure>
    <time_frame>Up to 26 Weeks</time_frame>
    <description>Allergic Response to Human Amnion Membrane Product Covering will be assessed clinically by the presence of dermatitis.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Burns</condition>
  <condition>Wound of Skin</condition>
  <condition>Skin Wound</condition>
  <arm_group>
    <arm_group_label>Amnion membrane product treatment area</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOC Wound Covering treatment area</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The donor wound site (Site B) will be covered per SOC (Standard of care).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amnion Membrane Powder</intervention_name>
    <description>This sterilized product is composed of lyophilized, gamma-irradiated powder made from amniotic membrane for topical application with the purpose of enhanced wound healing.</description>
    <arm_group_label>Amnion membrane product treatment area</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SOC Wound Covering</intervention_name>
    <description>Institutional standard of care wound covering.</description>
    <arm_group_label>Amnion membrane product treatment area</arm_group_label>
    <arm_group_label>SOC Wound Covering treatment area</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The subject requires autologous primary skin graft with two donor sites in similar&#xD;
             areas, each measuring at least 25 cm2 with the likely depth of 0.012 inches and&#xD;
             separated by a 5 cm gap. It is preferable that the two sites be on right and left&#xD;
             sides of the body, but it is not an exclusion if they must be on the same side.&#xD;
&#xD;
          -  Eligible primary wound sites may be traumatic or chronic, and will be at least 50 cm2&#xD;
             (that will receive the donor graft) to allow assessment of two separate experimental&#xD;
             donor sites of 25 cm2.&#xD;
&#xD;
          -  The subject is between the ages of 18 and 85 years of age.&#xD;
&#xD;
          -  The subject is willing to complete all follow-up evaluations required by the study&#xD;
             protocol.&#xD;
&#xD;
          -  The subject is to abstain from any other covering or treatment of the wound(s) for the&#xD;
             duration of the study unless medically necessary.&#xD;
&#xD;
          -  The subject agrees to abstain from enrollment in any other interventional clinical&#xD;
             trial for the duration of the study.&#xD;
&#xD;
          -  The subject and/or guardian is able to read and understand instructions and give&#xD;
             informed, voluntary, written consent.&#xD;
&#xD;
          -  The subject is able and willing to follow the protocol requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject's primary wound site is less than 50 cm2The subject's primary wound site&#xD;
             is not deemed appropriate for skin graft based upon the investigator's clinical&#xD;
             experience&#xD;
&#xD;
          -  The subject has a microbiologically proven pre-existing local or systemic bacterial&#xD;
             infection.&#xD;
&#xD;
          -  The subject has been receiving a systemic antibiotic for more than 48 hours prior to&#xD;
             grafting.&#xD;
&#xD;
          -  Unstable cardiac disorders within the past 6 months including angina, abnormal ECG,&#xD;
             history of cardiac arrest, surgery and/or other interventional procedure.&#xD;
&#xD;
          -  Hepatic disease or altered liver function as defined by ALT or AST value &gt;3 times the&#xD;
             upper limit of normal and/or T. Bilirubin &gt;1.5 mg/dL at screening&#xD;
&#xD;
          -  Renal disease or altered renal function as defined by serum creatinine &gt; 2 mg/dL at&#xD;
             screening, or end-stage renal disease.&#xD;
&#xD;
          -  Hemoglobin &lt;10.0 or &gt;19.0 g/dL&#xD;
&#xD;
          -  Known coagulopathy or platelet disorder, or INR &gt; 1.6 , PTT &gt; 38 sec; PLT &lt; 50,000 at&#xD;
             screening&#xD;
&#xD;
          -  The subject is known to have a pre-existing, chronic condition that, in the opinion of&#xD;
             the Investigator, may interfere with wound healing including but not limited to:&#xD;
             current malignancy, uncontrolled diabetes (HbA1c &gt;8) or diabetic ulcers, autoimmune&#xD;
             disease or other immunocompromised diseases, renal impairment or ESRD, liver disease,&#xD;
             hematological&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph Molnar, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Joseph Molnar, MD, PhD</last_name>
    <phone>13367164153</phone>
    <email>JMolnar@wakehealth.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mary Clare Day, RN</last_name>
    <phone>336-713-1343</phone>
    <email>mday@wakehealth.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>21929986</PMID>
  </reference>
  <reference>
    <citation>Rahmanian-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.</citation>
    <PMID>21852044</PMID>
  </reference>
  <reference>
    <citation>PIGEON J. Treatment of second-degree burns with amniotic membranes. Can Med Assoc J. 1960 Oct 15;83(16):844-5. No abstract available.</citation>
    <PMID>13735672</PMID>
  </reference>
  <reference>
    <citation>Faulk 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.</citation>
    <PMID>6155575</PMID>
  </reference>
  <reference>
    <citation>Bose B. Burn wound dressing with human amniotic membrane. Ann R Coll Surg Engl. 1979 Nov;61(6):444-7.</citation>
    <PMID>496235</PMID>
  </reference>
  <reference>
    <citation>Koob 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.</citation>
    <PMID>23902526</PMID>
  </reference>
  <reference>
    <citation>Sawhney 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.</citation>
    <PMID>2590408</PMID>
  </reference>
  <reference>
    <citation>C. 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).</citation>
  </reference>
  <reference>
    <citation>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 &amp; Dental Sciences, 3(2) (2016) 1-6.</citation>
  </reference>
  <reference>
    <citation>J.S. Davis, Skin transplantation, Johns Hopkins Hospital Reports 15 (1910) 307-96</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19474753</PMID>
  </reference>
  <reference>
    <citation>Honavar 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.</citation>
    <PMID>10811093</PMID>
  </reference>
  <reference>
    <citation>Mohammadi 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.</citation>
    <PMID>22951345</PMID>
  </reference>
  <reference>
    <citation>Branski 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.</citation>
    <PMID>17920202</PMID>
  </reference>
  <reference>
    <citation>Ravishanker R, Bath AS, Roy R. &quot;Amnion Bank&quot;--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.</citation>
    <PMID>12781617</PMID>
  </reference>
  <reference>
    <citation>Hermans MH. Preservation methods of allografts and their (lack of) influence on clinical results in partial thickness burns. Burns. 2011 Aug;37(5):873-81. doi: 10.1016/j.burns.2011.01.007. Epub 2011 Feb 25.</citation>
    <PMID>21353745</PMID>
  </reference>
  <reference>
    <citation>Fairbairn NG, Randolph MA, Redmond RW. The clinical applications of human amnion in plastic surgery. J Plast Reconstr Aesthet Surg. 2014 May;67(5):662-75. doi: 10.1016/j.bjps.2014.01.031. Epub 2014 Jan 31.</citation>
    <PMID>24560801</PMID>
  </reference>
  <reference>
    <citation>Lo K, Kohanim S, Trief D, Chodosh J. Role of amniotic membrane transplantation in acute chemical injury. Int Ophthalmol Clin. 2013 Fall;53(4):33-41. doi: 10.1097/IIO.0b013e31829ceec8. No abstract available.</citation>
    <PMID>24088931</PMID>
  </reference>
  <reference>
    <citation>Tseng SC, Prabhasawat P, Lee SH. Amniotic membrane transplantation for conjunctival surface reconstruction. Am J Ophthalmol. 1997 Dec;124(6):765-74. doi: 10.1016/s0002-9394(14)71693-9.</citation>
    <PMID>9402822</PMID>
  </reference>
  <reference>
    <citation>Ganatra MA. Amniotic membrane in surgery. J Pak Med Assoc. 2003 Jan;53(1):29-32. No abstract available.</citation>
    <PMID>12666850</PMID>
  </reference>
  <reference>
    <citation>Koziak A, Salagierski M, Marcheluk A, Szczesniewski R, Sosnowski M. Early experience in reconstruction of long ureteral strictures with allogenic amniotic membrane. Int J Urol. 2007 Jul;14(7):607-10. doi: 10.1111/j.1442-2042.2007.01781.x.</citation>
    <PMID>17645603</PMID>
  </reference>
  <reference>
    <citation>Tao H, Fan H. Implantation of amniotic membrane to reduce postlaminectomy epidural adhesions. Eur Spine J. 2009 Aug;18(8):1202-12. doi: 10.1007/s00586-009-1013-x. Epub 2009 Apr 30.</citation>
    <PMID>19404691</PMID>
  </reference>
  <reference>
    <citation>Chou CT, Lee C, Hwang JL. Amniotic membrane used for vulvar adhesion treatment. Arch Gynecol Obstet. 2001 Nov;265(4):223-4. doi: 10.1007/s004040000164.</citation>
    <PMID>11789753</PMID>
  </reference>
  <reference>
    <citation>Fetterolf DE, Snyder RJ. Scientific and clinical support for the use of dehydrated amniotic membrane in wound management. Wounds. 2012 Oct;24(10):299-307.</citation>
    <PMID>25876055</PMID>
  </reference>
  <reference>
    <citation>Zelen CM, Serena TE, Denoziere G, Fetterolf DE. A prospective randomised comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers. Int Wound J. 2013 Oct;10(5):502-7. doi: 10.1111/iwj.12097. Epub 2013 Jun 7.</citation>
    <PMID>23742102</PMID>
  </reference>
  <reference>
    <citation>Zelen CM. An evaluation of dehydrated human amniotic membrane allografts in patients with DFUs. J Wound Care. 2013 Jul;22(7):347-8, 350-1. doi: 10.12968/jowc.2013.22.7.347.</citation>
    <PMID>24159656</PMID>
  </reference>
  <reference>
    <citation>C.M. Zelen, T.E. Serena, D.E. Fetterolf, Dehydrated human amnion/chorion membrane allografts in patients with chronic diabetic foot ulcers: a long-term follow-up study, Wound Medicine 4 (2014) 1-4</citation>
  </reference>
  <reference>
    <citation>Forbes J, Fetterolf DE. Dehydrated amniotic membrane allografts for the treatment of chronic wounds: a case series. J Wound Care. 2012 Jun;21(6):290, 292, 294-6. doi: 10.12968/jowc.2012.21.6.290.</citation>
    <PMID>22886294</PMID>
  </reference>
  <reference>
    <citation>Sheikh ES, Sheikh ES, Fetterolf DE. Use of dehydrated human amniotic membrane allografts to promote healing in patients with refractory non healing wounds. Int Wound J. 2014 Dec;11(6):711-7. doi: 10.1111/iwj.12035. Epub 2013 Feb 15.</citation>
    <PMID>23409746</PMID>
  </reference>
  <reference>
    <citation>Bujang-Safawi E, Halim AS, Khoo TL, Dorai AA. Dried irradiated human amniotic membrane as a biological dressing for facial burns--a 7-year case series. Burns. 2010 Sep;36(6):876-82. doi: 10.1016/j.burns.2009.07.001. Epub 2010 Mar 16.</citation>
    <PMID>20236771</PMID>
  </reference>
  <reference>
    <citation>Subach BR, Copay AG. The use of a dehydrated amnion/chorion membrane allograft in patients who subsequently undergo reexploration after posterior lumbar instrumentation. Adv Orthop. 2015;2015:501202. doi: 10.1155/2015/501202. Epub 2015 Jan 13.</citation>
    <PMID>25653880</PMID>
  </reference>
  <reference>
    <citation>Kurd SK, Hoffstad OJ, Bilker WB, Margolis DJ. Evaluation of the use of prognostic information for the care of individuals with venous leg ulcers or diabetic neuropathic foot ulcers. Wound Repair Regen. 2009 May-Jun;17(3):318-25. doi: 10.1111/j.1524-475X.2009.00487.x.</citation>
    <PMID>19660039</PMID>
  </reference>
  <reference>
    <citation>Sen CK, Gordillo GM, Roy S, Kirsner R, Lambert L, Hunt TK, Gottrup F, Gurtner GC, Longaker MT. Human skin wounds: a major and snowballing threat to public health and the economy. Wound Repair Regen. 2009 Nov-Dec;17(6):763-71. doi: 10.1111/j.1524-475X.2009.00543.x.</citation>
    <PMID>19903300</PMID>
  </reference>
  <reference>
    <citation>Cherry DK, Hing E, Woodwell DA, Rechtsteiner EA. National Ambulatory Medical Care Survey: 2006 summary. Natl Health Stat Report. 2008 Aug 6;(3):1-39.</citation>
    <PMID>18972720</PMID>
  </reference>
  <reference>
    <citation>Pitts SR, Niska RW, Xu J, Burt CW. National Hospital Ambulatory Medical Care Survey: 2006 emergency department summary. Natl Health Stat Report. 2008 Aug 6;(7):1-38.</citation>
    <PMID>18958996</PMID>
  </reference>
  <reference>
    <citation>Miller SF, Bessey P, Lentz CW, Jeng JC, Schurr M, Browning S; ABA NBR Committee. National burn repository 2007 report: a synopsis of the 2007 call for data. J Burn Care Res. 2008 Nov-Dec;29(6):862-70; discussion 871. doi: 10.1097/BCR.0b013e31818cb046. No abstract available.</citation>
    <PMID>18997556</PMID>
  </reference>
  <reference>
    <citation>Cutting KF, Harding KG. Criteria for identifying wound infection. J Wound Care. 1994 Jun 2;3(4):198-201. doi: 10.12968/jowc.1994.3.4.198.</citation>
    <PMID>27922298</PMID>
  </reference>
  <reference>
    <citation>Baryza MJ, Baryza GA. The Vancouver Scar Scale: an administration tool and its interrater reliability. J Burn Care Rehabil. 1995 Sep-Oct;16(5):535-8. doi: 10.1097/00004630-199509000-00013.</citation>
    <PMID>8537427</PMID>
  </reference>
  <reference>
    <citation>Molnar JA, Lew WK, Rapp DA, Gordon ES, Voignier D, Rushing S, Willner W. Use of standardized, quantitative digital photography in a multicenter Web-based study. Eplasty. 2009;9:e4. Epub 2009 Jan 12.</citation>
    <PMID>19212431</PMID>
  </reference>
  <reference>
    <citation>Dornseifer U, Lonic D, Gerstung TI, Herter F, Fichter AM, Holm C, Schuster T, Ninkovic M. The ideal split-thickness skin graft donor-site dressing: a clinical comparative trial of a modified polyurethane dressing and aquacel. Plast Reconstr Surg. 2011 Oct;128(4):918-924. doi: 10.1097/PRS.0b013e3182268c02.</citation>
    <PMID>21681125</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>May 1, 2023</last_update_submitted>
  <last_update_submitted_qc>May 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Human amnion membrane</keyword>
  <keyword>Autologous skin graft</keyword>
  <keyword>Scar Formation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03754218
org study id: IRB00054157
nct id: NCT03754218
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of Donor Site Wound Closure
time frame: Week 4
description: 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.
measure: Incidence of Donor Site Wound Healing
time frame: week 12
description: Wound Healing for both amnion membrane product and SOC will be assessed clinically confirmed at two consecutive study visits 2 weeks apart.
measure: Presence of infection
time frame: up to 26 Weeks
description: The presence of infection will be evaluated in accordance with guidelines derived from Cutting and Harding using standard clinical measures.
measure: Vancouver Scar Assessment Scale
time frame: up to 26 Weeks
description: 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.
measure: Presence of Dermatitis
time frame: Up to 26 Weeks
description: Allergic Response to Human Amnion Membrane Product Covering will be assessed clinically by the presence of dermatitis.
arm group label: Amnion membrane product treatment area
arm group type: Experimental
description: 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.
arm group label: SOC Wound Covering treatment area
arm group type: Active Comparator
description: The donor wound site (Site B) will be covered per SOC (Standard of care).
intervention type: Drug
intervention name: Amnion Membrane Powder
description: This sterilized product is composed of lyophilized, gamma-irradiated powder made from amniotic membrane for topical application with the purpose of enhanced wound healing.
arm group label: Amnion membrane product treatment area
intervention type: Procedure
intervention name: SOC Wound Covering
description: Institutional standard of care wound covering.
arm group label: Amnion membrane product treatment area
arm group label: SOC Wound Covering treatment area
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Joseph Molnar, MD, PhD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
last name: Joseph Molnar, MD, PhD
phone: 13367164153
email: JMolnar@wakehealth.edu
last name: Mary Clare Day, RN
phone: 336-713-1343
email: mday@wakehealth.edu
facility: 
status: Recruiting
country: United States
citation: 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.
PMID: 21929986
citation: Rahmanian-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.
PMID: 21852044
citation: PIGEON J. Treatment of second-degree burns with amniotic membranes. Can Med Assoc J. 1960 Oct 15;83(16):844-5. No abstract available.
PMID: 13735672
citation: Faulk 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.
PMID: 6155575
citation: Bose B. Burn wound dressing with human amniotic membrane. Ann R Coll Surg Engl. 1979 Nov;61(6):444-7.
PMID: 496235
citation: Koob 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.
PMID: 23902526
citation: Sawhney 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.
PMID: 2590408
citation: C. 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).
citation: 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.
citation: J.S. Davis, Skin transplantation, Johns Hopkins Hospital Reports 15 (1910) 307-96
citation: 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.
PMID: 19474753
citation: Honavar 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.
PMID: 10811093
citation: Mohammadi 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.
PMID: 22951345
citation: Branski 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.
PMID: 17920202
citation: Ravishanker 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.
PMID: 12781617
citation: Hermans MH. Preservation methods of allografts and their (lack of) influence on clinical results in partial thickness burns. Burns. 2011 Aug;37(5):873-81. doi: 10.1016/j.burns.2011.01.007. Epub 2011 Feb 25.
PMID: 21353745
citation: Fairbairn NG, Randolph MA, Redmond RW. The clinical applications of human amnion in plastic surgery. J Plast Reconstr Aesthet Surg. 2014 May;67(5):662-75. doi: 10.1016/j.bjps.2014.01.031. Epub 2014 Jan 31.
PMID: 24560801
citation: Lo K, Kohanim S, Trief D, Chodosh J. Role of amniotic membrane transplantation in acute chemical injury. Int Ophthalmol Clin. 2013 Fall;53(4):33-41. doi: 10.1097/IIO.0b013e31829ceec8. No abstract available.
PMID: 24088931
citation: Tseng SC, Prabhasawat P, Lee SH. Amniotic membrane transplantation for conjunctival surface reconstruction. Am J Ophthalmol. 1997 Dec;124(6):765-74. doi: 10.1016/s0002-9394(14)71693-9.
PMID: 9402822
citation: Ganatra MA. Amniotic membrane in surgery. J Pak Med Assoc. 2003 Jan;53(1):29-32. No abstract available.
PMID: 12666850
citation: Koziak A, Salagierski M, Marcheluk A, Szczesniewski R, Sosnowski M. Early experience in reconstruction of long ureteral strictures with allogenic amniotic membrane. Int J Urol. 2007 Jul;14(7):607-10. doi: 10.1111/j.1442-2042.2007.01781.x.
PMID: 17645603
citation: Tao H, Fan H. Implantation of amniotic membrane to reduce postlaminectomy epidural adhesions. Eur Spine J. 2009 Aug;18(8):1202-12. doi: 10.1007/s00586-009-1013-x. Epub 2009 Apr 30.
PMID: 19404691
citation: Chou CT, Lee C, Hwang JL. Amniotic membrane used for vulvar adhesion treatment. Arch Gynecol Obstet. 2001 Nov;265(4):223-4. doi: 10.1007/s004040000164.
PMID: 11789753
citation: Fetterolf DE, Snyder RJ. Scientific and clinical support for the use of dehydrated amniotic membrane in wound management. Wounds. 2012 Oct;24(10):299-307.
PMID: 25876055
citation: Zelen CM, Serena TE, Denoziere G, Fetterolf DE. A prospective randomised comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers. Int Wound J. 2013 Oct;10(5):502-7. doi: 10.1111/iwj.12097. Epub 2013 Jun 7.
PMID: 23742102
citation: Zelen CM. An evaluation of dehydrated human amniotic membrane allografts in patients with DFUs. J Wound Care. 2013 Jul;22(7):347-8, 350-1. doi: 10.12968/jowc.2013.22.7.347.
PMID: 24159656
citation: C.M. Zelen, T.E. Serena, D.E. Fetterolf, Dehydrated human amnion/chorion membrane allografts in patients with chronic diabetic foot ulcers: a long-term follow-up study, Wound Medicine 4 (2014) 1-4
citation: Forbes J, Fetterolf DE. Dehydrated amniotic membrane allografts for the treatment of chronic wounds: a case series. J Wound Care. 2012 Jun;21(6):290, 292, 294-6. doi: 10.12968/jowc.2012.21.6.290.
PMID: 22886294
citation: Sheikh ES, Sheikh ES, Fetterolf DE. Use of dehydrated human amniotic membrane allografts to promote healing in patients with refractory non healing wounds. Int Wound J. 2014 Dec;11(6):711-7. doi: 10.1111/iwj.12035. Epub 2013 Feb 15.
PMID: 23409746
citation: Bujang-Safawi E, Halim AS, Khoo TL, Dorai AA. Dried irradiated human amniotic membrane as a biological dressing for facial burns--a 7-year case series. Burns. 2010 Sep;36(6):876-82. doi: 10.1016/j.burns.2009.07.001. Epub 2010 Mar 16.
PMID: 20236771
citation: Subach BR, Copay AG. The use of a dehydrated amnion/chorion membrane allograft in patients who subsequently undergo reexploration after posterior lumbar instrumentation. Adv Orthop. 2015;2015:501202. doi: 10.1155/2015/501202. Epub 2015 Jan 13.
PMID: 25653880
citation: Kurd SK, Hoffstad OJ, Bilker WB, Margolis DJ. Evaluation of the use of prognostic information for the care of individuals with venous leg ulcers or diabetic neuropathic foot ulcers. Wound Repair Regen. 2009 May-Jun;17(3):318-25. doi: 10.1111/j.1524-475X.2009.00487.x.
PMID: 19660039
citation: Sen CK, Gordillo GM, Roy S, Kirsner R, Lambert L, Hunt TK, Gottrup F, Gurtner GC, Longaker MT. Human skin wounds: a major and snowballing threat to public health and the economy. Wound Repair Regen. 2009 Nov-Dec;17(6):763-71. doi: 10.1111/j.1524-475X.2009.00543.x.
PMID: 19903300
citation: Cherry DK, Hing E, Woodwell DA, Rechtsteiner EA. National Ambulatory Medical Care Survey: 2006 summary. Natl Health Stat Report. 2008 Aug 6;(3):1-39.
PMID: 18972720
citation: Pitts SR, Niska RW, Xu J, Burt CW. National Hospital Ambulatory Medical Care Survey: 2006 emergency department summary. Natl Health Stat Report. 2008 Aug 6;(7):1-38.
PMID: 18958996
citation: Miller SF, Bessey P, Lentz CW, Jeng JC, Schurr M, Browning S; ABA NBR Committee. National burn repository 2007 report: a synopsis of the 2007 call for data. J Burn Care Res. 2008 Nov-Dec;29(6):862-70; discussion 871. doi: 10.1097/BCR.0b013e31818cb046. No abstract available.
PMID: 18997556
citation: Cutting KF, Harding KG. Criteria for identifying wound infection. J Wound Care. 1994 Jun 2;3(4):198-201. doi: 10.12968/jowc.1994.3.4.198.
PMID: 27922298
citation: Baryza MJ, Baryza GA. The Vancouver Scar Scale: an administration tool and its interrater reliability. J Burn Care Rehabil. 1995 Sep-Oct;16(5):535-8. doi: 10.1097/00004630-199509000-00013.
PMID: 8537427
citation: Molnar JA, Lew WK, Rapp DA, Gordon ES, Voignier D, Rushing S, Willner W. Use of standardized, quantitative digital photography in a multicenter Web-based study. Eplasty. 2009;9:e4. Epub 2009 Jan 12.
PMID: 19212431
citation: Dornseifer U, Lonic D, Gerstung TI, Herter F, Fichter AM, Holm C, Schuster T, Ninkovic M. The ideal split-thickness skin graft donor-site dressing: a clinical comparative trial of a modified polyurethane dressing and aquacel. Plast Reconstr Surg. 2011 Oct;128(4):918-924. doi: 10.1097/PRS.0b013e3182268c02.
PMID: 21681125
responsible party type: Sponsor
mesh term: Wounds and Injuries
sharing ipd: No