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Role of Vacuum in Open Fracture Tibia Grade III Type B

Primary Purpose

Open Fracture of Tibia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
vacuum assistant closure
CONVENTIONAL DRESSING
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open Fracture of Tibia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • - Gustilo Type III B open fractures of the tibia [10].
  • Skeletal mature patients.

Exclusion Criteria:

  • - Bone defect more than 5 cm Gustilo Type III B open fractures of the tibia.
  • Medical commodities that make the patient unfit for surgery. (e.g. Liver Cell Failure, liver cirrhosis, renal failure )

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    group A

    group B

    Arm Description

    Group A will be treated with vacuum assistant closure

    Group B will be treated with conventional dressing

    Outcomes

    Primary Outcome Measures

    - Time for definitive soft tissue coverage
    - Evaluate the role of VAC in decreasing the time needed for soft tissue coverage and definitive fixation in open IIIB tibial fractures

    Secondary Outcome Measures

    - The type of soft tissue reconstruction

    Full Information

    First Posted
    August 19, 2019
    Last Updated
    August 19, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04063111
    Brief Title
    Role of Vacuum in Open Fracture Tibia Grade III Type B
    Official Title
    ROLE OF VACUUM ASSISTED CLOSURE IN OPEN TYPE III B TIBIAL FRACTURES
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 15, 2019 (Anticipated)
    Primary Completion Date
    October 15, 2021 (Anticipated)
    Study Completion Date
    April 15, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    - Evaluate the role of VAC in decreasing the time needed for soft tissue coverage and definitive fixation in open IIIB tibial fractures
    Detailed Description
    Open fractures are injuries in which the skin and soft-tissue integument are disrupted and the underlying bone is exposed to the external environment. This communication results in contamination by microorganisms that can cause deep or superficial infection. Impaired vascularity, devitalized tissue, and loss of skeletal stability are all factors leading to increased susceptibility to infection after open fracture [1, 2]. 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,].

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Open Fracture of Tibia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group A
    Arm Type
    Active Comparator
    Arm Description
    Group A will be treated with vacuum assistant closure
    Arm Title
    group B
    Arm Type
    Active Comparator
    Arm Description
    Group B will be treated with conventional dressing
    Intervention Type
    Device
    Intervention Name(s)
    vacuum assistant closure
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    CONVENTIONAL DRESSING
    Intervention Description
    CONVENTIONAL DRESSING for wound of open fracture of tibia grade III B
    Primary Outcome Measure Information:
    Title
    - Time for definitive soft tissue coverage
    Description
    - Evaluate the role of VAC in decreasing the time needed for soft tissue coverage and definitive fixation in open IIIB tibial fractures
    Time Frame
    baseline
    Secondary Outcome Measure Information:
    Title
    - The type of soft tissue reconstruction
    Time Frame
    baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: - Gustilo Type III B open fractures of the tibia [10]. Skeletal mature patients. Exclusion Criteria: - Bone defect more than 5 cm Gustilo Type III B open fractures of the tibia. Medical commodities that make the patient unfit for surgery. (e.g. Liver Cell Failure, liver cirrhosis, renal failure )
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Albair malaka sedki, Risedent
    Phone
    01024336337
    Email
    albairalbair@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    OSAMA AHMED FAROUK, Professor
    Phone
    01222443531
    Email
    Osama_farouk@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28985633
    Citation
    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. Erratum In: J Reconstr Microsurg. 2017 Oct;33(S 01):e1.
    Results Reference
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    Role of Vacuum in Open Fracture Tibia Grade III Type B

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