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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06388915
Other study ID # K2202403004
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 12, 2024
Est. completion date March 23, 2024

Study information

Verified date April 2024
Source Fujian Provincial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Some related factors of pelvic fracture and Morel-Lavallee injury (MLL) are preliminarily discussed, which provides some preliminary references for early clinical detection and research of such injuries.


Description:

Inclusion criteria: (1) The clinical symptoms are consistent with the diagnosis of pelvic fracture, and the diagnosis is confirmed by imaging, including emergency or sub-emergency CT data within 72 hours after injury. (2) The symptoms of the diagnosis of MLL were pain and swelling at the site of occurrence, a sense of soft tissue fluctuation found on physical examination, and a complete process of puncture drainage + negative pressure suction therapy. (3) The patients and their families have given informed consent to this study and signed the informed consent form, which meets the ethical requirements. Exclusion criteria: (1) Incomplete imaging data, especially the lack of emergency or sub-emergency CT data within 72 hours after injury. (2) Cases of other severe lower limb fractures such as femur and trochanter, and lower limb fractures combined with MLL injury have been reported in the literature.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date March 23, 2024
Est. primary completion date March 20, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - (1) The clinical symptoms are consistent with the diagnosis of pelvic fracture, and the diagnosis is confirmed by imaging, including emergency or sub-emergency CT data within 72 hours after injury. (2) The symptoms of the diagnosis of MLL were pain and swelling at the site of occurrence, a sense of soft tissue fluctuation found on physical examination, and a complete process of puncture drainage + negative pressure suction therapy. (3) The patients and their families have given informed consent to this study and signed the informed consent form, which meets the ethical requirements. Exclusion Criteria: - (1) Incomplete imaging data, especially the lack of emergency or sub-emergency CT data within 72 hours after injury. (2) Cases of other severe lower limb fractures such as femur and trochanter, and lower limb fractures combined with MLL injury have been reported in the literature.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Fujian Provincial Hospital Fuzhou Fujian

Sponsors (1)

Lead Sponsor Collaborator
Weikang Chen

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Site of MLL Site of the occurrence of Morel-Lavallee lesion 5 days
Primary Site of injury and Classification of pelvic fracture Site of injury and Classification of pelvic fracture 72 hours
Secondary Time to treatment Time of treatment for Morel-Lavallee lesion 10 days
Secondary Drainage volume Drainage volume for Morel-Lavallee lesion 10 days
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