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Hardware Preservation in Management of Infected Non United or Delayed United Fractures of Long or Short Bones by Debridement and Local Calcium Sulfate Loaded by Antibiotics

NCT05231148 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-03-23

No results posted yet for this study

Summary

* Diagnosis of infection based on elevated serum markers of infection (ESR, CRP), discharging sinus, preoperative radiographs suggestive of bone infection and radiological findings . \[6\]
* infected nonunion mean the bone has previous fracture , the bone not healed may be one of the reasons it didn't heal because there is sub-acute infection , there is low grade colonization into the bone or around the wound preventing the bone from healing , it different from infected fracture which occur fairly acutely. \[6, 7\]
* Infected nonunion treated with systemic antibiotics alone, without using local antibiotic delivery systems associated with higher recurrence and reoperation rates. \[7\]
* This led to the development and use of medical-grade calcium sulfate (CS), CS facilitates osseous healing in an osteoconductive fashion by filling the bone void and preventing fibrous tissue

Conditions

  • Infected Non Union and Delayed Union in Fractures of Both Long and Short Bones

Interventions

PROCEDURE

local debridement and local calcium sulfate loaded by antibiotics

debridement of infected non united fractures and placement of local calcium sulfate loaded by antibiotic then follow up at regular intervals

Sponsors & Collaborators

  • Sohag University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-12
Primary Completion
2023-06-30
Completion
2023-10-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05231148 on ClinicalTrials.gov