Status:
TERMINATED
Use of a Medical Food in Adults Undergoing Surgery
Lead Sponsor:
Abbott Nutrition
Conditions:
Compliance, Patient
Eligibility:
All Genders
60+ years
Phase:
NA
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
- 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
- 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
Key Trial Info
Start Date :
March 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2020
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04041908
Start Date
March 13 2020
End Date
April 10 2020
Last Update
May 1 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
ClinOhio Research Services
Columbus, Ohio, United States, 43213