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

Not Applicable

Recruiting

• 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

• Registration Number: NCT05231148
• Lead Sponsor: Sohag University

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-12
• Study First Submitted: 2022-01-12
• Study First Submitted QC: 2022-01-28
• Study First Posted: 2022-02-09
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-23
• Primary Completion: 2023-06
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
infected non united fractures	local debridement and local calcium sulfate loaded by antibiotics	patient of any age and any sex with infected non united fractures of long or short bones

Primary Outcome Measures

Name	Time	Method
Non union scoring system	one year	Non-Union Scoring System (NUSS) aims to classify non-unions according to their severity and relate them to four treatment categories.
Karlström-Olerud physical function scale	one year	Karlström-Olerud physical function scale is a scale to assess physical functional outcome postoperative.

Trial Locations

Locations (1)

Sohag University Hospital; 🇪🇬 Sohag, Egypt