Effect of High Doses of Vitamin C on the Tissular Reparation (Healing) in Patients Under Surgery in the "Hospital de Los Valles".
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Evaluation of linear scars
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Older than 18 years.
- •Susceptible for any of the following surgical procedures: (1) cesarean section; (2) aesthetic abdominal plastic surgery; (3) orthopedic prosthetic replacement surgery
- •Voluntary consent to participate
Exclusion Criteria
- •Known allergy to the vitamin C
- •Known problems with wounds healing
- •Kidney disease (including lithiasis) or gout
Outcomes
Primary Outcomes
Evaluation of linear scars
Time Frame: third assessment, three months after surgery
Patient and Observer Scar Assessment Scale (it evaluates in a 0 to 10 scale: vascularity, pigmentation, thickness, relief, pliability and surface area)
Secondary Outcomes
No secondary outcomes reported
Investigators
Enrique Teran
Principal Investigator
Universidad San Francisco de Quito