Use of a Medical Food in Adults Undergoing Surgery

• Sponsor: Abbott Nutrition (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT04041908
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Arm: 1
• Actual Duration (Days): 28
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Compliance, Patient	Other: Experimental Product	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Observation of the Use of a Medical Food in Older Adults Undergoing Surgery
• Actual Study Start Date: Mar 13, 2020
• Actual Primary Completion Date: Apr 10, 2020
• Actual Study Completion Date: Apr 10, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Product Compliance [Study Day 1 to Study Day 30]

   Percent of required study product intake from subject completed intake questionnaire

Secondary Outcome Measures

1. Investigator Wound Assessment [Study Day 1 to Study Day 30]

   Percent of patients with complete wound healing based on physician assessment

2. 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

Other Outcome Measures

1. Product Evaluation Questionnaire [Study Day 30/Exit]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ClinOhio Research Services	Columbus	Ohio	United States	43213

Sponsors and Collaborators

• Abbott Nutrition

Investigators

• Study Chair: Jeffrey Nelson, PhD, Abbott Nutrition

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Nutrition
• ClinicalTrials.gov Identifier: NCT04041908
• Other Study ID Numbers: BL42
• First Posted: Aug 1, 2019
• Last Update Posted: May 1, 2020
• Last Verified: Apr 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 1, 2020