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Therapeutic evaluation of treatment with EDTA-NS irrigation solution for open fracture wound: A Prospective, Double-Blind, Randomized, Multicenter clinical Trial

Therapeutic evaluation of treatment with EDTA-NS irrigation solution for open fracture wound: A Prospective, Double-Blind, Randomized, Multicenter clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074949
Enrollment
Unknown
Registered
2023-08-21
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-08-28

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

Conditions

open fracture

Interventions

intervention group:EDTA-NS irrigation group
control group:NS irrigation group

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Male or female patients over 18 years of age; (2) open fractures (Gustilo-Anderson I-IIIB); (3) Patients who are able to sign informed consent on their own;

Exclusion criteria

Exclusion criteria: (1) open fracture with vascular damage (Gustilo-Anderson IIIC type); (2) Multiple fractures; (3) Patients who are known to be allergic to normal saline or EDTA or to root canal irrigation during dental surgery; (4) Previous local wound infection or history of osteomyelitis in the injured limb; (5) Presence of digestive tract infection or lung infection (6) Injured for more than 24 hours (7) Patients who have used immunosuppressive drugs or taken glucocorticoids for a long time within 6 months; (8) Patients in the chemotherapy phase of tumors; (9) Patients with immunodeficiency diseases (such as HIV); (10) Patients with hand fractures (metacarpophalangeal fractures); (11) Patients with phalangeal fractures (12) Patients who have participated in other clinical studies; (13) The patient is a prisoner or a high-risk patient who is incarcerated during the follow-up period; (14) Patients with mental illness, Alzheimer's disease or inability to communicate; (15) Pregnant patients; (16) Patients who are unable to participate in the full course of the study within 12 months

Design outcomes

Primary

MeasureTime frame
Secondary operation occurs due to recurrence of infection, poor wound healing, or poor fracture healing within 12 months of initial surgery;

Secondary

MeasureTime frame
SF-12 scale scoring;Details of non-surgical treatment forrecurrence of infection, poor wound healing, or poor fracture healing within 12 months of initial surgery;SPOC scale scoring;

Countries

China

Contacts

Public ContactXianyou Zheng

Shanghai Sixth People's Hospital

zhengxianyou@126.com+86 139 1618 0968

Outcome results

None listed

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