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This study is being conducted to decrease the rate of surgical wound complications. The investigators are studying the effects that caloric restriction has on decreasing the rate of surgical wound complications.
The goal is to decrease the chance of having wound complications after surgery. Caloric Restriction has been found to be a natural modifier of surgical outcomes. Participants will be randomize into the arms Caloric Restriction Diet or Normal Diet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caloric Restriction Diet | Experimental | Patients will meet with the Registered Dietitian to discuss calorie, protein, and fluid needs.The dietitian will calculate calorie needs.
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| Normal Diet | No Intervention | Participant will follow a normal diet. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caloric Restriction Diet | Other | Two nutritional supplements, one from Ensure (Abbott Laboratories, Chicago, IL) and one from Boost (Nestle, Vevey, Switzerland) will be used for 3 days before surgery. The supplements are the Ensure Pre-Surgery Clear Carbohydrate Drink and the Ensure Original Nutrition Powder. The Original Nutrition Powder will be mixed with 8oz of water, oat milk, or almond milk. The proposed macronutrient profile for the 3 days of caloric restriction (CR) is less than 8% of calories from protein. |
| Measure | Description | Time Frame |
|---|---|---|
| Change In The Rate Of Physical Function By MSTS | The Musculoskeletal Tumor Society Rating Scale (MSTS) is a clinician-based scoring system that is scored out of 35 points. A higher score indicates better physical function. | Baseline, 6 weeks, 3 months and 6 months visits after surgery |
| Change In The Rate Of Physical Function By TESS | The Toronto Extremity Salvage Score (TESS) is a patient-reported scoring system that is scored out of 100 points. A higher score indicates better physical function. | Baseline, 6 weeks, 3 months and 6 months visits after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The Rate Of Wound Healing | 2 years | |
| The Rate Of Wound Complications In The Protein Caloric Restriction (PCR) Versus Control Group | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Santiago A Lozano-Calderón, MD, PhD | Contact | 617-643-4947 | slozanocalderon@mgh.harvard.edu | |
| Shreya Halur, BS | Contact | 617-726-4932 | shalur@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Santiago A Lozano-Calderón, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts general Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
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| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |