An observational study in Fractures, Open, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-18.
Sponsored by Assiut University · Observational
The aim of this study is to assess interobserver reliability, sensitivity for amputation, and specificity for salvage of GHS in type-III injuries with open tibial fractures and predict the potential number of inpatient days, secondary procedures that would be required, and the rate of infection
Open fractures are usually high-energy injuries that can lead to life-threatening multiple injuries. It is classified as an orthopaedic emergency, and successful treatment depends on a thorough assessment and prompt treatment of the patient and wound. With the rise in severe open tibia injuries, an ideal scoring system with high specificity and sensitivity for predicting limb salvage is required. A misdiagnosis can lead to unnecessary amputations or salvage operations. A variety of scoring methods have been described for limb salvaging. The Gustilo and Anderson classification system is still the most used. Following the original classification, typeIII injuries were subdivided into type-IIIA, which denoted adequate soft-tissue coverage of the fracture despite extensive skin loss, type-IIIB, which denoted extensive soft-tissue loss, periosteal stripping, and bone exposure; and type-IIIC, which denoted an open fracture with an associated arterial injury that required repair. It has the limitations of a low intra and inter-observer agreement rate, low specificity and sensitivity to salvage and ambulation, and an inability to predict functional results in the care of Type IIIB injuries. The Ganga Hospital Score (GHS) is an open injury score developed from a high-volume trauma center that treats more than 600 open lower-limb fractures each year, far higher than a typical major trauma center in the United Kingdom. Following three clinical trials, the score was developed and has been shown to accurately predict whether a limb can be saved or must be amputated. The scoring system's nature, which takes into account particular injuries to the bone, skin, and musculotendinous units, as well as comorbid factors, has also been expanded to advise wound treatment. In medicine, scoring systems are used to rate the severity of an illness, predict the outcome, and aid in management decisions. In open injuries, an ideal score would have a sensitivity of 100%, with all limbs requiring amputation scoring at or above the threshold value, and a specificity of 100%, with all limbs that can be preserved scoring below the threshold value. Because these injuries are frequently complex clinical conditions, this is challenging to achieve. Although it is preferable to err on the side of high specificity such that only a small percentage of salvageable limbs score over the amputation threshold, high sensitivity is also necessary to limit the number of secondary amputations.
53 studies on the registry are indexed under Fractures, Open; 14 are open to participants now.
This study's planned enrollment of 87 is close to the median of 93 across 13 observational studies indexed under Fractures, Open.
Browse Fractures, Open studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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trauma patient with open tibial fractures type-IIIA/B
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Exclusion Criteria:
with a score below 14
Procedure: Debridement with Ex_Fix (salvage)
with a score above 14
Procedure: BKA
Below Knee Amputation: * Under spinal anesthesia * BKA * closure in layers (terminal closure) with suction drain.
Debridement and External Fixation (salvage): * Under spinal anesthesia * wound debridement and wash. * external fixation.
sensitivity and specificity GHS in type- IIIA/B open tibial fractures
salvage with score below 14 and Amputation with score above 14
Time frame: one year
No study locations are listed for this record.
Start is estimated for Dec 2022; primary completion for May 2023, 5 months later.
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This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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