High Doses Vitamin C and Tissular Repair in Surgical Patients

Tissue Damage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04896359
• Other study ID #: HUBI - 14539
• Status: Completed
• Phase: N/A
• Start date: March 15, 2019
• Est. completion date: March 3, 2021

Study information

• Verified date: September 2021
• Source: Universidad San Francisco de Quito
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 3, 2021
• Est. primary completion date: March 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tissue Damage

Intervention

Dietary Supplement:
• Vitamin C
12.5 grams of ascorbic acid

Other:
• Placebo
vehicle

Locations

Country	Name	City	State
Ecuador	Hospital de los Valles	Quito	Pichincha

Sponsors (2)

Lead Sponsor	Collaborator
Universidad San Francisco de Quito	Biomolec Pharma

Country where clinical trial is conducted

Ecuador, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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