Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Biomolec Pharma | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
This is a prospective, randomize, double-blind, and placebo-controlled study to evaluate in patients with clinical criteria for any of the following open surgical procedure: (1) cesarean section; (2) aesthetic surgery like abdominoplasty; (3) orthopedic surgery; and (4) abdominal open surgery [excluding laparoscopic procedures] will be invited to receive either a high dose of vitamin C (12.5 g) three times (48 h pre-surgery, immediately before surgery and 48 h post-surgery) or its placebo, to evaluate the tissue repair process using an international validated instrument named Patient and Observer Scar Assessment Scale.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin C | Experimental | i.v. infusion of 12.5 g vitamin C 48 h before surgery, immediately before surgery, and 48 h after surgery |
|
| Control | Placebo Comparator | i.v. infusion of placebo 48 h before surgery, immediately before surgery, and 48 h after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin C | Dietary Supplement | 12.5 grams of ascorbic acid |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of linear scars | Patient and Observer Scar Assessment Scale (it evaluates in a 0 to 10 scale: vascularity, pigmentation, thickness, relief, pliability and surface area) | initial assessment, two weeks after surgery |
| Evaluation of linear scars | Patient and Observer Scar Assessment Scale (it evaluates in a 0 to 10 scale: vascularity, pigmentation, thickness, relief, pliability and surface area) | second assessment, one month after surgery |
| Evaluation of linear scars | Patient and Observer Scar Assessment Scale (it evaluates in a 0 to 10 scale: vascularity, pigmentation, thickness, relief, pliability and surface area) | third assessment, three months after surgery |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Enrique Teran | Universidad San Francisco de Quito | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de los Valles | Quito | Pichincha | Ecuador |
Not provided
| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Other |
vehicle |
|
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |