Use of a Medical Food in Adults Undergoing Surgery

Not Applicable

Terminated

• Conditions: Compliance, Patient

• Registration Number: NCT04041908
• Lead Sponsor: Abbott Nutrition

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-30
• Study First Submitted QC: 2019-07-31
• Study First Posted: 2019-08-01
• Study Start: 2020-03-13
• Status Verified: 2020-04
• Primary Completion: 2020-04-10
• Study Completion: 2020-04-10
• Last Update Submitted: 2020-04-29
• Last Update Posted: 2020-05-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Product Compliance	Study Day 1 to Study Day 30	Percent of required study product intake from subject completed intake questionnaire

Secondary Outcome Measures

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

Trial Locations

Locations (1)

ClinOhio Research Services; 🇺🇸 Columbus, Ohio, United States