High Doses Vitamin C and Tissular Repair in Surgical Patients

NCT ID: NCT04896359

Last Updated: 2021-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-15

Study Completion Date

2021-03-03

Brief Summary

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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

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Conditions

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Tissue Damage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Vitamin C

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

Group Type EXPERIMENTAL

Vitamin C

Intervention Type DIETARY_SUPPLEMENT

12.5 grams of ascorbic acid

Control

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

vehicle

Interventions

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Vitamin C

12.5 grams of ascorbic acid

Intervention Type DIETARY_SUPPLEMENT

Placebo

vehicle

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biomolec Pharma

UNKNOWN

Sponsor Role collaborator

Universidad San Francisco de Quito

OTHER

Sponsor Role lead

Responsible Party

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Enrique Teran

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Enrique Teran

Role: PRINCIPAL_INVESTIGATOR

Universidad San Francisco de Quito

Locations

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Hospital de los Valles

Quito, Pichincha, Ecuador

Site Status

Countries

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Ecuador

Other Identifiers

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HUBI - 14539

Identifier Type: -

Identifier Source: org_study_id

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