Role of Vacuum in Open Fracture Tibia Grade III Type B
ROLE OF VACUUM ASSISTED CLOSURE IN OPEN TYPE III B TIBIAL FRACTURES
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
\- Evaluate the role of VAC in decreasing the time needed for soft tissue coverage and definitive fixation in open IIIB tibial fractures
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2019
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2019
CompletedFirst Posted
Study publicly available on registry
August 21, 2019
CompletedStudy Start
First participant enrolled
October 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2022
CompletedAugust 21, 2019
August 1, 2019
2 years
August 19, 2019
August 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
- 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
baseline
Secondary Outcomes (1)
- The type of soft tissue reconstruction
baseline
Study Arms (2)
group A
ACTIVE COMPARATORGroup A will be treated with vacuum assistant closure
group B
ACTIVE COMPARATORGroup B will be treated with conventional dressing
Interventions
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 for wound of open fracture of tibia grade III B
Eligibility Criteria
You may qualify if:
- \- Gustilo Type III B open fractures of the tibia \[10\].
- Skeletal mature patients.
You may not qualify if:
- \- 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 )
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 28985633BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident of orthopedic surgery department
Study Record Dates
First Submitted
August 19, 2019
First Posted
August 21, 2019
Study Start
October 15, 2019
Primary Completion
October 15, 2021
Study Completion
April 15, 2022
Last Updated
August 21, 2019
Record last verified: 2019-08