Compliance, Patient
Conditions
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.
Interventions
OTHERExperimental Product
2 sachets per day
Sponsors
Abbott Nutrition
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Product Compliance | Study Day 1 to Study Day 30 | Percent of required study product intake from subject completed intake questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed