High Doses Vitamin C and Tissular Repair in Surgical Patients

Universidad San Francisco de Quito

Status: Completed

Conditions: Tissue Damage

Treatments: Other: Placebo; Dietary Supplement: Vitamin C

Study type: Interventional

Funder types: Other

Identifiers

NCT04896359

HUBI - 14539

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Vitamin C

Experimental group

Description:

i.v. infusion of 12.5 g vitamin C 48 h before surgery, immediately before surgery, and 48 h after surgery

Treatment:

Dietary Supplement: Vitamin C

Control

Placebo Comparator group

Description:

i.v. infusion of placebo 48 h before surgery, immediately before surgery, and 48 h after surgery

Treatment:

Other: Placebo