High Doses Vitamin C and Tissular Repair in Surgical Patients

NCT04896359 | Completed

• 1 other identifier: HUBI - 14539
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Tissue Damage

Outcome Measures

Primary Outcomes (3)

• Evaluation of linear scars

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

  initial assessment, two weeks after surgery

• Evaluation of linear scars

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

  second assessment, one month after surgery

• Evaluation of linear scars

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

  third assessment, three months after surgery

Study Arms (2)

Vitamin C

EXPERIMENTAL

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

Dietary Supplement: Vitamin C

Control

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Vitamin C DIETARY_SUPPLEMENT

12.5 grams of ascorbic acid

Vitamin C

Placebo OTHER

vehicle

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known allergy to the vitamin C
• Known problems with wounds healing
• Kidney disease (including lithiasis) or gout

Sponsors & Collaborators

• Universidad San Francisco de Quito: lead
• Biomolec Pharma: collaborator

Study Sites (1)

Hospital de los Valles

Quito, Pichincha, Ecuador

Location

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Enrique Teran

  Universidad San Francisco de Quito

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 21, 2021
• Study Start: March 15, 2019
• Primary Completion: March 3, 2021
• Study Completion: March 3, 2021
• Last Updated: October 4, 2021

Record last verified: 2021-09

Locations

EC (1)