Use of a Medical Food in Adults Undergoing Surgery

Abbott

Status: Terminated

Conditions: Compliance, Patient

Treatments: Other: Experimental Product

Study type: Interventional

Funder types: Industry

Identifiers

NCT04041908

BL42

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Experimental Product

Experimental group

Description:

Drink mix powder

Treatment:

Other: Experimental Product