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Evaluation of the Effect of Anticoagulant Treatment on Wound Complications in Patients Undergoing Spinal Fusion Surgery at Shafa Yahyaiyan Hospital: A Randomized Controlled Trial

Evaluation of the Effect of Anticoagulant Treatment on Wound Complications in Patients Undergoing Spinal Fusion Surgery at Shafa Yahyaiyan Hospital: A Randomized Controlled Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250901067071N1
Enrollment
200
Registered
2025-09-18
Start date
2025-09-23
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post-operative spinal fusion infection. Other and unspecified infectious diseases

Interventions

Intervention group: Using Apixaban for DVT/PE prevention.

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: All patients aged 18 to 75 who are candidates for elective spinal fusion surgery. Patients who meet the inclusion criteria and have no contraindications to anticoagulant medications.

Exclusion criteria

Exclusion criteria: Bleeding or active coagulation disorders: Patients with bleeding problems such as hemophilia, vitamin K deficiency, or genetic disorders leading to uncontrollable bleeding must be excluded from the study. Active infection at the surgical site: Patients who have an active infection in the spine or other parts of the body at the time of surgery or beforehand will be excluded due to the high risk of wound infections and other complications. Known allergy or hypersensitivity to study medications: Patients with hypersensitivity to anticoagulant medications used in the study (such as Apixaban or ASA) must be excluded. Pregnancy or breastfeeding: Due to physiological and hormonal changes that may affect treatment, as well as potential risks for the fetus or infant, patients who are pregnant or breastfeeding will be excluded from the study. Chronic or advanced diseases: Patients with uncontrolled chronic diseases (such as advanced renal or hepatic failure) or conditions that impair wound healing must be excluded. Emergency surgeries or procedures requiring urgent intervention: Patients undergoing emergency surgeries will not be included in the study due to significant differences in treatment protocols and the need for immediate interventions. Inability to provide informed consent: Patients who, for any reason, are unable to understand the study details or provide informed consent will be excluded. History of previous spinal surgeries. History of surgical site infection following non-spinal surgeries. History of hypercoagulability, DVT, or PTE.

Design outcomes

Primary

MeasureTime frame
Surgical site infection. Timepoint: 2 weeks; 1 month; 3 months after surgery. Method of measurement: clinical evaluation and inflammatory markers evaluation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammadreza Chehrassan

Iran University of Medical Sciences

morchehrasan@yahoo.com+98 21 3848 7000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026