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Trial record 1 of 1 for:    NCT03754218
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Amnion Wound Covering for Enhanced Wound Healing

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ClinicalTrials.gov Identifier: NCT03754218
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : May 27, 2022
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Burns Wound of Skin Skin Wound Drug: Amnion Membrane Powder Procedure: SOC Wound Covering Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Human Amnion Membrane Powder for Enhanced Wound Healing
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Amnion membrane product treatment area
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
This sterilized product is composed of lyophilized, gamma-irradiated powder made from amniotic membrane for topical application with the purpose of enhanced wound healing.

Procedure: SOC Wound Covering
Institutional standard of care wound covering.

Active Comparator: SOC Wound Covering treatment area
The donor wound site (Site B) will be covered per SOC (Standard of care).
Procedure: SOC Wound Covering
Institutional standard of care wound covering.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Incidence of Donor Site Wound Healing [ Time Frame: week 12 ]
    Wound Healing for both amnion membrane product and SOC will be assessed clinically confirmed at two consecutive study visits 2 weeks apart.

  2. Presence of infection [ Time Frame: up to 26 Weeks ]
    The presence of infection will be evaluated in accordance with guidelines derived from Cutting and Harding using standard clinical measures.

  3. Vancouver Scar Assessment Scale [ Time Frame: up to 26 Weeks ]
    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.

  4. Presence of Dermatitis [ Time Frame: Up to 26 Weeks ]
    Allergic Response to Human Amnion Membrane Product Covering will be assessed clinically by the presence of dermatitis.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03754218

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Contact: Joseph Molnar, MD, PhD 13367164153 JMolnar@wakehealth.edu
Contact: Mary Clare Day, RN 336-713-1343 mday@wakehealth.edu

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United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
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Principal Investigator: Joseph Molnar, MD, PhD Wake Forest University Health Sciences
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).
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
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

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03754218    
Other Study ID Numbers: IRB00054157
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: May 27, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Human amnion membrane
Autologous skin graft
Scar Formation
Additional relevant MeSH terms:
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Wounds and Injuries