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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-12

Study Completion Date

2023-10-31

Brief Summary

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* 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

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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infected non united fractures

patient of any age and any sex with infected non united fractures of long or short bones

Group Type OTHER

local debridement and local calcium sulfate loaded by antibiotics

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient at any age and of any sex with infected non united fracture of long or short bones

Exclusion Criteria

* Presence of previous vascular injury or pathological fracture
* Refusal to participate
* Inability to provide informed consent
* Allergy or sensitivity to vancomycin or tobramycin
* Patient with impaired renal function
* Patient with hypercalcemia

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes