Study Results
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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UNKNOWN
NA
60 participants
INTERVENTIONAL
2019-10-15
2022-04-15
Brief Summary
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Detailed Description
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* Current protocols for treating open fractures include early administration of antibiotics, timely surgical debridement, skeletal stabilization, sterile dressing, systemic support, and establishment of soft-tissue coverage in a wound environment that is clean \[3, 4-8\].
* VAC is being used to obviate the need for, or enhance the success of, free-flap coverage in open fractures that are significant enough to preclude primary closure, delayed primary closure, or healing by secondary intention. VAC device and its components, which in a closed system expose the open wound bed to negative pressure. This pressure removes edema or hemorrhage, mechanically pulls on the wound edges, decreases in wound surface area, improves circulation, and enhances proliferation of granulation tissue that filled the soft tissue defect, enhance debridement of wound debris, reducing the need for costly free-flap transfers. VAC devices have been used in many surgical disciplines but only recently have become popular in orthopedics \[7, 9,\].
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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group A
Group A will be treated with vacuum assistant closure
vacuum assistant closure
Expose the open wound bed to negative pressure. This pressure removes edema or hemorrhage, mechanically pulls on the wound edges, decreases in wound surface area, improves circulation, and enhances proliferation of granulation tissue that filled the soft tissue defect.
group B
Group B will be treated with conventional dressing
CONVENTIONAL DRESSING
CONVENTIONAL DRESSING for wound of open fracture of tibia grade III B
Interventions
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vacuum assistant closure
Expose the open wound bed to negative pressure. This pressure removes edema or hemorrhage, mechanically pulls on the wound edges, decreases in wound surface area, improves circulation, and enhances proliferation of granulation tissue that filled the soft tissue defect.
CONVENTIONAL DRESSING
CONVENTIONAL DRESSING for wound of open fracture of tibia grade III B
Eligibility Criteria
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Inclusion Criteria
* Skeletal mature patients.
Exclusion Criteria
* Medical commodities that make the patient unfit for surgery. (e.g. Liver Cell Failure, liver cirrhosis, renal failure )
18 Years
ALL
Yes
Sponsors
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Assiut University
OTHER
Responsible Party
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Albair Malaka Sedki
Resident of orthopedic surgery department
Central Contacts
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References
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Cherubino M, Valdatta L, Tos P, D'Arpa S, Troisi L, Igor P, Corradi F, Khan U. Role of Negative Pressure Therapy as Damage Control in Soft Tissue Reconstruction for Open Tibial Fractures. J Reconstr Microsurg. 2017 Oct;33(S 01):S08-S13. doi: 10.1055/s-0037-1606542. Epub 2017 Oct 6.
Other Identifiers
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VAC in open fracture tibia
Identifier Type: -
Identifier Source: org_study_id
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