High Doses Vitamin C and Tissular Repair in Surgical Patients

Not Applicable

Completed

• Conditions: Tissue Damage
• Interventions: Dietary Supplement: Vitamin C; Other: Placebo

• Registration Number: NCT04896359
• Lead Sponsor: Universidad San Francisco de Quito

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-15
• Primary Completion: 2021-03-03
• Study Completion: 2021-03-03
• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-14
• Study First Posted: 2021-05-21
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin C	Vitamin C	i.v. infusion of 12.5 g vitamin C 48 h before surgery, immediately before surgery, and 48 h after surgery
Control	Placebo	i.v. infusion of placebo 48 h before surgery, immediately before surgery, and 48 h after surgery

Primary Outcome Measures

Name	Time	Method
Evaluation of linear scars	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)

Trial Locations

Locations (1)

Hospital de los Valles; 🇪🇨 Quito, Pichincha, Ecuador