Role of Vacuum in Open Fracture Tibia Grade III Type B

Assiut University

Status: Unknown

Conditions: Open Fracture of Tibia

Treatments: Device: vacuum assistant closure; Device: CONVENTIONAL DRESSING

Study type: Interventional

Funder types: Other

Identifiers

NCT04063111

VAC in open fracture tibia

Details and patient eligibility

About

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

Full 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,].

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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 )

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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60 participants in 2 patient groups

group A

Active Comparator group

Description:

Group A will be treated with vacuum assistant closure

Treatment:

Device: vacuum assistant closure

group B

Active Comparator group

Description:

Group B will be treated with conventional dressing

Treatment:

Device: CONVENTIONAL DRESSING