In this study, we investigate the use of vitamin C in flexor tendon repair and compare its complications and effectiveness with non-injection repair method.
Design
A clinical trial with a control group, with parallel randomized groups, was used to assign numbers to patients based on random number table numbers for randomization.
Settings and conduct
The surgeon and the patient are aware of the methods of surgical treatment, but the person who performs the patients' functional measurements after surgery is blind to the type of surgical procedure of the patients.
Participants/Inclusion and exclusion criteria
Patient with a laceration in zone 2; immune system defects; patients with concomitant fractures; patients with crush injury; patients with a closed tendon injury
Intervention groups
In this study, we will repair tendon damage in group A using vitamin C injections and group B without injections.
Main outcome variables
Success rate and range of motion are the main results
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211201053235N7
Registration date:2022-06-25, 1401/04/04
Registration timing:prospective
Last update:2022-06-25, 1401/04/04
Update count:0
Registration date
2022-06-25, 1401/04/04
Registrant information
Name
Meisam Jafari Kafiabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8000
Email address
dr.jafari8567@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the results of vitamin C injection in flexor tendon repair in zone II
Public title
Flexor tendon repair in zone II
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with tendon injury in zone 2
Exclusion criteria:
Immune system defects
Close tendon injury
Crush injury
Concomitant fracture
Age
From 20 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Shahid Beheshti University of Medical Sciences
Intervention group: Patients with laceration in zone 2 of the hand , after repairing the flexor tendon and closing the wound, 5 cc of vitamin C is injected at the site of repair and then plaster cast is performed. The next day after surgery, the passive flexion and active extension movements for the patients begin, and 5 weeks later, the patient's cast was opened and physiotherapy is requested.