Use of a Medical Food in Adults Undergoing Surgery

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

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.

Study Overview

• Status: Terminated
• Conditions: Compliance, Patient
• Intervention / Treatment: Other: Experimental Product

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43213
      • ClinOhio Research Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Product; Drink mix powder	Other: Experimental Product; 2 sachets per day

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Product Evaluation Questionnaire	Participant completed questionnaire; 4 Likert-type questions scaled from 1 - 9 in the negative direction; 2 Likert-type questions scaled from 1 - 5 in the negative direction	Study Day 30/Exit

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Jeffrey Nelson, PhD, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2020
• Primary Completion (Actual): April 10, 2020
• Study Completion (Actual): April 10, 2020

Study Registration Dates

• First Submitted: July 30, 2019
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (Actual): August 1, 2019

Study Record Updates

• Last Update Posted (Actual): May 1, 2020
• Last Update Submitted That Met QC Criteria: April 29, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: BL42

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No