Use of a Medical Food in Adults Undergoing Surgery

Compliance, Patient Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04041908
• Other study ID #: BL42
• Status: Terminated
• Phase: N/A
• Start date: March 13, 2020
• Est. completion date: April 10, 2020

Study information

• Verified date: April 2020
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 10, 2020
• Est. primary completion date: April 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Compliance, Patient

Intervention

Other:
• Experimental Product
2 sachets per day

Locations

Country	Name	City	State
United States	ClinOhio Research Services	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Product Compliance	Percent of required study product intake from subject completed intake questionnaire	Study Day 1 to Study Day 30
Secondary	Investigator Wound Assessment	Percent of patients with complete wound healing based on physician assessment	Study Day 1 to Study Day 30
Secondary	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