Amnion Wound Covering for Enhanced Wound Healing

NCT03754218 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: IRB00054157
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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. The amnion powder product is composed of "lyophilized" (freeze-dried), "gamma irradiation sterilized" (exposed to bacteria killing radiation) fragments of amniotic membrane.

Conditions

Burns; Wound of Skin; Skin Wound

Keywords

Human amnion membrane; Autologous skin graft; Scar Formation

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 4

Secondary Outcomes (4)

• Incidence of Donor Site Wound Healing

  week 12

• Presence of infection

  up to 26 Weeks

• Vancouver Scar Assessment Scale

  up to 26 Weeks

• Presence of Dermatitis

  Up to 26 Weeks

Study Arms (2)

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.

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).

Procedure: SOC Wound Covering

Interventions

Amnion Membrane Powder DRUG

This sterilized product is composed of lyophilized, gamma-irradiated powder made from amniotic membrane for topical application with the purpose of enhanced wound healing.

Amnion membrane product treatment area

SOC Wound Covering PROCEDURE

Institutional standard of care wound covering.

Amnion membrane product treatment area; SOC Wound Covering treatment area

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (40)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Bose B. Burn wound dressing with human amniotic membrane. Ann R Coll Surg Engl. 1979 Nov;61(6):444-7.

  PMID: 496235 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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).

  BACKGROUND

• 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.

  BACKGROUND

• J.S. Davis, Skin transplantation, Johns Hopkins Hospital Reports 15 (1910) 307-96

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Ganatra MA. Amniotic membrane in surgery. J Pak Med Assoc. 2003 Jan;53(1):29-32. No abstract available.

  PMID: 12666850 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Joseph Molnar, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: November 27, 2018
• Study Start: December 1, 2019
• Primary Completion: November 22, 2023
• Study Completion: November 22, 2023
• Last Updated: January 9, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)