A Prospective, Open-Label, Randomized, Controlled Post-Market Clinical Trial Investigating the Safety and Effectiveness of Human Amnion Membrane (AM) in a Cohort of Patients with Loss of Full Thickness Skin Graft Following Reconstruction of a Cutaneous Nasal Defect Secondary to Skin Cancer Resection.
Princess Alexandra Hospital
33 participants
Nov 25, 2024
Interventional
Conditions
Summary
This research is designed to determine the clinical utility of a human amnion membrane (biological) product and assess whether it is safe and effective in a group of patients that have a failed full thickness skin graft (FTSG) on their nasal tip or nasal ala in the previous 3 months. It is hypothesized that participants who receive an amnion membrane allograft will have superior epithelization and revascularization resulting in improved healing and a reduction in scar contracture compared with patients receiving standard of care management. Who is it for? You may be eligible to participate in this study if you are male or female aged 18 years or older, fluent in written and spoken English, is a Southeast Queensland (SEQ)-based resident, and within 3 months of a failed full-thickness skin graft (FTSG) characterised by ongoing pain, numbness, erythema, oedema where this clear tissue breakdown and a presence of necrotic eschar. Study details At the time of screening, study participants will be randomized to receive active treatment with an amnion membrane allograft or standard of care. For participants in the amnion membrane allograft group, the nasal wound bed will be cleaned and previous failed graft removed. Then amniotic membrane will be transplanted in to the wound bed and secured with Hypafix tape. A secondary dressing that enables moistened wound healing will be applied above the amnion membrane allograft. After the procedure is complete, patients will be discharged following a review of their vital signs. Study participants will return to clinic at Day 6 (+/- 2) and Day 11 (+/- 2) after intervention, to have their outer dressing changed and the amnion bandage reviewed. At one month and 3 months post-operatively, the study participants will return for further assessments of the wound bed. Imaging investigations of the graft site will be conducted at each follow up visit using a 3D surface scanning device, along with a symptom-directed physical exam and collection of vital sign measures, concomitant medications, and adverse events. A final follow up visit will be conducted at three months after amnion membrane allograft transplant. At the End of Study visit, the wound bed will be assessed for epithelial repair and graft function. It is hoped the finding from this study will show human amnion membrane (biological) is a superior epithelization and revascularization in treating FTSG, improve healing and a reduction in scar contracture compared with standard care management.
Eligibility
Inclusion Criteria4
- Patients who are 18 years or older.
- Fluent in written and spoken English and in a position to provide written informed consent to participate without the need of a SHA.
- Southeast Queensland (SEQ)-based resident who can attend all scheduled follow up visits after their amnion allograft intervention.
- Within 3 months of a failed full thickness skin graft (FTSG) characterised by ongoing pain, numbness, erythema, oedema where this clear tissue breakdown and a presence of necrotic eschar.
Exclusion Criteria20
- A concurrent condition that may limit the decision-making capabilities of the participant during the informed consent process.
- Head and neck radiation treatment within the last 6 months.
- A positive diagnosis of Human Immunodeficiency Virus (HIV) or Hepatitis C Virus (HCV with confirmation by polymerase chain reaction diagnostic methods) or Hepatitis B Virus (HBV) infection or IgM positive results to Human Cytomegalovirus (HCMV) or IgM positive results for Epstein Barr Virus (EBV) or Human T Cell Lymphotropic Virus (HTLV-1).
- Chronic immunosuppression either as a function of current management for pre-existing autoimmune, autoinflammatory, solid organ transplantation or other haematological condition.
- Acute or chronic graft versus host disease.
- Uncontrolled Type 1 or type 2 diabetes.
- Past history of carcinoma (within the last 5 years) not including focal squamous cell carcinoma, melanoma or basal cell carcinoma of the skin that is fully resolved following surgical or medical intervention.
- Uncontrolled systemic hypertension (>180/110 mmHg) at the screening visit.
- A genetic condition that is known to impact the connective tissue and affect wound healing characteristics such as Loeys-Dietz, Ehlers-Danlos Syndrome
- A history of severe allergies which has resulted in previous anaphylactic incidents.
- A hypersensitivity response to the amnion allograft intervention or similar biological product.
- Fever and other signs and symptoms of concurrent infection – either focal or systemic
- Recent travel (within the last 3 months) to areas where exposure to parasites or other infectious agents is highly likely.
- Serum Alanine Transaminase (ALT) or Aspartate Amino Transferase (AST) ?3-fold the upper limit of normal (ULN) or AST/ALT ratio > 2 ULN or Bilirubin ?2-fold the upper limit of normal at the screening visit.
- Severe renal impairment where creatinine clearance <30mL/minute at the time of screening based on recent clinical chemistry results.
- Major elective surgery scheduled during active treatment intervention and follow up.
- Concurrent enrolment in another interventional (drug or device) clinical trial whilst enrolled in this clinical trial (i.e., between screening and the last follow up visit).
- Clinically significant medical conditions including but not limited to cardiovascular, neurological, psychiatric, renal, hepatic, haematological or endocrine pathology that in the investigator’s opinion are uncontrolled, severe or end-stage and likely to affect the patient’s ability to comply with the study requirements.
- Grade III obesity (BMI equal to, or greater than 40) with metabolic syndrome.
- Social factors that may likely affect the capacity of patient to attend regular study visits as per the schedule of events.
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Interventions
An amnion membrane allograft (Revita® Full Thickness Native Placental Membrane) will be used to aid with epithelization and revascularization of failed nasal skin grafts. Firstly, the nasal wound bed will be debrided and excoriated material from the previous failed graft removed. When the amniotic membrane has been appropriately sized and correctly orientated, it will be transplanted into the wound bed and secured with Hypafix tape. A secondary dressing that enables moistened wound healing will be applied above the amnion membrane allograft. This intervention will be performed by an experienced study doctor at the Princess Alexandra Hospital. After the procedure is complete, patients will be discharged following a review of their vital signs. Study participants will return to clinic at Day 6 (+/- 2) and Day 11 (+/- 2) after intervention, to have their outer dressing changed and the amnion bandage reviewed. At one month and 3 months post-operatively, the study participants will return for further assessments of the wound bed. Imaging investigations of the graft site will be conducted at each follow up visit using a 3D surface scanning device, along with a symptom-directed physical exam and collection of vital sign measures, concomitant medications, and adverse events. A final follow up visit will be conducted at three months after amnion membrane allograft transplant. At the End of Study visit, the wound bed will be assessed for epithelial repair and graft function. 1A. The duration of the debridement procedure including the amnion allograft will be approximately 30 minutes. Wound review will occur at each follow up. This is a surgical intervention and not medical intervention and the patient will not be responsible for applying the treatment. A registered nurse will change the dressings. The dressing will take approximately 15 minutes to remove and change. 2C. A Study Investigator will conduct the 1 month and 3 month review. The patient will not be responsible for applying the surgical intervention. Safety and effectiveness will be assessed from adverse events, concomitant illnesses, concomitant medications and devices, physical exam findings, clinical pathology results, quality of life questionnaires, wound review observations including surface scanning and clinical photographs.
Locations(1)
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ACTRN12624001342505