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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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05231148
Enrollment
10
Registered
2022-02-09
Start date
2021-12-12
Completion date
2023-10-31
Last updated
2023-03-23

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

Conditions

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

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

Interventions

PROCEDURElocal 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

Sohag University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Non union scoring systemone yearNon-Union Scoring System (NUSS) aims to classify non-unions according to their severity and relate them to four treatment categories.
Karlström-Olerud physical function scaleone yearKarlström-Olerud physical function scale is a scale to assess physical functional outcome postoperative.

Countries

Egypt

Contacts

Primary ContactAbdelraheem m sonbol, resident
abdelreheem011115@med.sohag.edu.eg01121280438
Backup Contactabdelrahman h khalifa, professor
01003701283

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026