100% Whey Protein Based Diet In Enhancing Pressure Ulcer Healing.
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|ClinicalTrials.gov Identifier: NCT03995407|
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : June 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pressure Ulcer||Dietary Supplement: Peptamen® Other: Usual Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel 2-arm pilot randomized controlled trial|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||100% Whey Protein Based Diet In Enhancing Pressure Ulcer Healing- A Pilot Randomized Controlled Trial.|
|Actual Study Start Date :||June 20, 2019|
|Estimated Primary Completion Date :||February 20, 2020|
|Estimated Study Completion Date :||February 20, 2020|
Active Comparator: Control
Participants in the control arm will receive "usual care".
Other: Usual Care
Participants receive "usual care". They will be categorised into those who are not currently taking oral nutritional supplement and those who are currently on oral nutritional supplements (non-100% whey i.e. not on Peptamen® or Beneprotein®). They will consume their regular diet in accordance with the dietician's recommendations.
Experimental: 100% Whey Protein
Participants will receive 100% Whey Protein oral nutritional supplements.
Dietary Supplement: Peptamen®
Participants in the intervention arm will be categorised into those who are not currently taking oral nutritional supplement and those who are currently on oral nutritional supplements. Those who are not currently taking oral nutritional supplement will be started on Peptamen® while those who are currently on oral nutritional supplements will have to convert to Peptamen® solely. The dietician will determine the amount of Peptamen® required per day based on the recommendations of the product information. Should the participant's daily protein requirement not be met be Peptamen® alone, the dietician will recommend additional whey protein to be added in the form of Beneprotein® Instant Protein Powder. Beneprotein® is a concentrated source of high-quality whey protein that can be added to most foods, liquids or enteral formulas.
- Percentage Reduction in Wound Surface Area [ Time Frame: 4 weeks ]Percentage reduction in wound surface area = [Surface area at baseline - Surface area after 4 weeks] / [Surface area at baseline] %
- Pressure Ulcer Score for Healing (PUSH) Score [ Time Frame: 4 weeks ]The Pressure Ulcer Scale for Healing (PUSH Tool) was developed by the National Pressure Ulcer Advisory Panel (NPUAP) as a quick, reliable tool to monitor the change in pressure ulcer status over time. The total score ranges from 0 (best condition) to 17 (worst condition) and is derived from 3 parameters (product of length and width of wound, exudate amount, and tissue type).
- Amount of Peptamen® and Beneprotein® consumed [ Time Frame: 4 weeks ]Measured in grams.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995407
|Contact: Jeffrey Jiang Song'en, MBBSemail@example.com|
|Contact: Kavitha D/O Sanmugam, MNfirstname.lastname@example.org|
|St Luke's Hospital||Recruiting|
|Singapore, Singapore, 659674|
|Principal Investigator:||Jeffrey Jiang Song'en, MBBS||St. Luke's Hospital|