Skip to main content
OpenTrials
Completed

NCT Number: NCT04896359

High Doses Vitamin C and Tissular Repair in Surgical Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tissue Damage

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de los Valles

Quito, Pichincha, Ecuador

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin C

Dietary Supplement

12.5 grams of ascorbic acid

Placebo

Other

vehicle

Primary outcomes

  1. Evaluation of linear scars

    Time frame: 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)

  2. Evaluation of linear scars

    Time frame: second assessment, one month after surgery

    Patient and Observer Scar Assessment Scale (it evaluates in a 0 to 10 scale: vascularity, pigmentation, thickness, relief, pliability and surface area)

  3. 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)

Sponsors and collaborators

Lead sponsor

Universidad San Francisco de Quito

Other

Collaborators

  • Biomolec Pharma

Registry information

Official study title

Effect of High Doses of Vitamin C on the Tissular Reparation (Healing) in Patients Under Surgery in the "Hospital de Los Valles".

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 21, 2021
Registry last updated
Oct 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.