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| Name | Class |
|---|---|
| Medical Nutrition USA, Inc. | INDUSTRY |
Investigators performed a randomized controlled trial of 62 patients undergoing elective abdominal operations. The treatment group was provided a liquid protein supplement and instructed to take a dose three times daily for the first 20 postoperative days. Investigators followed patients for six months and compared wound healing and changes in weight and laboratory values.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | The patients in the control group did not receive any supplementation, and were directed to follow the dietary guidelines of their surgeon. |
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| Treatment | Experimental | Patients were instructed to consume one ounce (containing 16 grams of protein) of the supplement three times daily. No other modifications were made to the patient's diet. Patients were provided with a total of 60 doses, which would last 20 days if they consumed each dose as instructed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostat AWC | Dietary Supplement | Prostat AWC- patients received protein supplementation after surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in weight | Mean preoperative weight compared to mean postoperative weight at each follow-up appointment. Weight recorded in pounds, subsequent measurements at each postoperative point were normalized to the preoperative weight and reported as a relative percentage of the preoperative weight. | Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing | Overall wound healing was documented on a scale of 0-2 (0 for unhealed, 1 for partially healed, 2 for completely healed). A wound was considered partially healed if there was any portion of the wound which had epidermal edges that were not in direct contact. | Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Placebo | Other | Placebo- Patients did not take any protein supplementation after surgery |
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| Change in white blood cell count (1x10 3/ uL) | Change in white blood cell count relative to preoperative white blood cell count, calculated as absolute change | Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months |
| Change in total protein (g/ dL) | Change in total protein at each follow-up point relative to preoperative total protein, calculated as absolute change | Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months |
| Change in albumin (g/ dL) | Change in albumin at each follow-up point relative to preoperative albumin, calculated as absolute change | Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months |
| Change in prealbumin (mg/ dL) | Change in prealbumin at each follow-up point relative to preoperative prealbumin, calculated as absolute change | Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months |