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Role of Vacuum in Open Fracture Tibia Grade III Type B

ROLE OF VACUUM ASSISTED CLOSURE IN OPEN TYPE III B TIBIAL FRACTURES

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04063111
Enrollment
60
Registered
2019-08-21
Start date
2019-10-15
Completion date
2022-04-15
Last updated
2019-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open Fracture of Tibia

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 \[7, 9,\].

Interventions

DEVICEvacuum 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 for wound of open fracture of tibia grade III B

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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 )

Design outcomes

Primary

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

Secondary

MeasureTime frame
- The type of soft tissue reconstructionbaseline

Contacts

Primary ContactAlbair malaka sedki, Risedent
albairalbair@yahoo.com01024336337
Backup ContactOSAMA AHMED FAROUK, Professor
Osama_farouk@yahoo.com01222443531

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026