Infection Rate With Intramedullary Interlocking Nail Versus Plate Fixation in Open Tibial Fractures
Infection Rate of ILN vs Plate in Open Fracture Tibia Treated With Prophylactic Antibiotic
Open fractures of the tibia are at risk of infection because the injury damages the surrounding soft tissues. This study will compare the frequency of postoperative infection in patients with Gustilo-Anderson type I and II open tibial shaft fractures treated with intramedullary interlocking nail (ILN) fixation or plate fixation after three days of intravenous prophylactic antibiotic therapy.
A total of 170 patients aged 18-60 years will be included and randomly allocated into two groups of 85 patients each. Group A will undergo ILN fixation, while Group B will undergo plate fixation. Patients will be monitored for signs of infection, including pain, redness, swelling, and wound discharge, during hospital stay and follow-up. The main outcome will be the presence of postoperative infection within three months of surgery.
The findings may help clinicians compare infection rates between these two fixation methods in open tibial shaft fractures.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Muhammad Asif Asif Khan, post graduate trainee orthopa
- Telefonnummer: +923012996395
- E-post: wazirkhancr768@gmail.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
-
Inclusion Criteria
- Patients aged 18-60 years.
- Both genders.
- Gustilo-Anderson type I and II open tibial shaft fractures.
- Patients receiving three days of intravenous antibiotic therapy prior to definitive fixation.
Exclusion Criteria:
-
• Gustilo-Anderson type III fractures.
- Pathological fractures.
- Polytrauma patients.
- Patients with diabetes mellitus, immunosuppression, or peripheral vascular disease.
- Previous surgery on the affected limb
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Arm 1Intramedullary Interlocking Nail Fixation
Patients will undergo surgical fixation of open tibial fractures using an intramedullary interlocking nail. |
Surgical fixation of open tibial fractures using an intramedullary interlocking nail. |
|
Aktiv komparator: Arm 2 Plate Fixation
Patients will undergo surgical fixation of open tibial fractures using plate fixation. |
Surgical fixation of open tibial fractures using plate and screw fixation. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Frequency of Postoperative Infection
Tidsramme: Within 3 months after surgery
|
Postoperative infection will be assessed by the presence of clinical signs of infection, including pain, redness, swelling, and wound discharge, with or without a positive wound culture. Infection rates will be compared between patients treated with intramedullary interlocking nail fixation and plate fixation. |
Within 3 months after surgery
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative Pain Score
Tidsramme: Third postoperative day
|
Postoperative pain will be assessed using the Visual Analog Scale (VAS) and compared between the two treatment groups. |
Third postoperative day
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 48.ERC/FMU/2025-26/366
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Individual participant data will not be shared with other researchers. The data will be kept confidential and used only for the purposes of this research study. Access to study data will be restricted to authorized members of the research team.
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