Tissue Damage
Conditions
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.
Interventions
DIETARY_SUPPLEMENTVitamin C
12.5 grams of ascorbic acid
OTHERPlacebo
vehicle
Sponsors
Biomolec Pharma
Universidad San Francisco de Quito
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of linear scars | initial assessment, two weeks after surgery | Patient and Observer Scar Assessment Scale (it evaluates in a 0 to 10 scale: vascularity, pigmentation, thickness, relief, pliability and surface area) |
Countries
Ecuador
Outcome results
None listed