Clinical trial NCT04041908: Use of a Medical Food in Adults Undergoing Surgery
Official title: Observation of the Use of a Medical Food in Older Adults Undergoing Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Compliance, Patient
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2019-08-01
Enrollment: 1
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Product Compliance
timeFrame: Study Day 1 to Study Day 30
Secondary outcomes:
measure: Investigator Wound Assessment
timeFrame: Study Day 1 to Study Day 30
measure: Participant Wound Assessment Questionnaire
timeFrame: Study Day 14 and Study Day 30
Other outcomes:
measure: Product Evaluation Questionnaire
timeFrame: Study Day 30/Exit
Locations:
city: Columbus
country: United States
facility: ClinOhio Research Services
state: Ohio
Study officials:
affiliation: Abbott Nutrition
name: Jeffrey Nelson, PhD
role: STUDY_CHAIR
References: