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
About this trial
This is an interventional treatment trial for Open Fracture of Tibia
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 )
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
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
background
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Role of Vacuum in Open Fracture Tibia Grade III Type B
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