Use of a Medical Food in Adults Undergoing Surgery

NCT ID: NCT04041908

Last Updated: 2020-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-13

Study Completion Date

2020-04-10

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.

Detailed Description

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Conditions

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Compliance, Patient

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Experimental Product

Drink mix powder

Group Type EXPERIMENTAL

Experimental Product

Intervention Type OTHER

2 sachets per day

Interventions

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Experimental Product

2 sachets per day

Intervention Type OTHER

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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey Nelson, PhD

Role: STUDY_CHAIR

Abbott Nutrition

Locations

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ClinOhio Research Services

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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BL42

Identifier Type: -

Identifier Source: org_study_id

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