Use of a Medical Food in Adults Undergoing Surgery

Study Overview
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Brief Summary
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Multi-center, prospective, one arm study to evaluate the addition of a medical food to the standard of care in elderly adults undergoing a surgical procedure.

Official Title
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Observation of the Use of a Medical Food in Older Adults Undergoing Surgery

Conditions
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Compliance, Patient

Intervention / Treatment
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* Other: Experimental Product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is scheduled to have non-melanoma skin cancer on either the head, leg, trunk and arm removed with final wound size of 1.0 to < 5.0 cm in diameter or with 1.0 < 5.0 cm long axis if not circular that will be healed by secondary intent Participant has an acceptable state of health and nutrition Participant agrees not to begin taking any new medications, dietary supplements, or alternative therapies during the study period Participant is interested in participating in the study, willing to comply with the study protocol, and willing to consume two servings of drink mix per day according to the protocol Participant has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability (HIPAA) authorization prior to any study participation Exclusion Criteria: Participant has a disease or condition that could interfere with the assessment of safety and efficacy of the study treatment and compliance of the participant with study visits/procedures Participant has type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus Participant has known immunosuppression Participant has platelet or coagulation disorders Therapy with another investigational agent within 30 days of Visit 1 that has not been approved Systemic infection at the time of enrollment in the study Currently receiving or have received recombinant human platelet-derived growth factor or similar therapies, or other bioengineered tissue therapy within the previous 4 weeks Participant has an allergy or intolerance to any ingredient in the study product Participant is taking nutritional supplement(s)/capsules/formulas for wound healing and is unwilling to discontinue therapy for the duration of the study Participation in another clinical study

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Product<br>Drink mix powder | Other: Experimental Product<br>* 2 sachets per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Product Compliance | Percent of required study product intake from subject completed intake questionnaire | Study Day 1 to Study Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Wound Assessment | Percent of patients with complete wound healing based on physician assessment | Study Day 1 to Study Day 30 | 
| Participant Wound Assessment Questionnaire | Participant completed 4 questions related to wound healing experience; 3 Likert-type questions scaled from 1-10 in negative direction; 1 dichotomous scale question | Study Day 14 and Study Day 30 |