Use of a Medical Food in Adults Undergoing Surgery

NCT04041908 | Terminated

• 1 other identifier: BL42
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Compliance, Patient

Outcome Measures

Primary Outcomes (1)

• Product Compliance

  Percent of required study product intake from subject completed intake questionnaire

  Study Day 1 to Study Day 30

Secondary Outcomes (2)

• Investigator Wound Assessment

  Study Day 1 to Study Day 30

• Participant Wound Assessment Questionnaire

  Study Day 14 and Study Day 30

Other Outcomes (1)

• Product Evaluation Questionnaire

  Study Day 30/Exit

Study Arms (1)

Experimental Product

EXPERIMENTAL

Drink mix powder

Other: Experimental Product

Interventions

Experimental Product OTHER

2 sachets per day

Experimental Product

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (1)

ClinOhio Research Services

Columbus, Ohio, 43213, United States

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Jeffrey Nelson, PhD

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 1, 2019
• Study Start: March 13, 2020
• Primary Completion: April 10, 2020
• Study Completion: April 10, 2020
• Last Updated: May 1, 2020

Record last verified: 2020-04

Locations

US (1)