Role of Vacuum in Open Fracture Tibia Grade III Type B

Not Applicable

• Conditions: Open Fracture of Tibia
• Interventions: Device: vacuum assistant closure; Device: CONVENTIONAL DRESSING

• Registration Number: NCT04063111
• Lead Sponsor: Assiut University

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 \[7, 9,\].

Study Timeline

• Status Verified: 2019-08
• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-08-19
• Last Update Submitted: 2019-08-19
• Study First Posted: 2019-08-21
• Last Update Posted: 2019-08-21
• Study Start: 2019-10-15
• Primary Completion: 2021-10-15
• Study Completion: 2022-04-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 )

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
group A	vacuum assistant closure	Group A will be treated with vacuum assistant closure
group B	CONVENTIONAL DRESSING	Group B will be treated with conventional dressing

Primary Outcome Measures

Name	Time	Method
- Time for definitive soft tissue coverage	baseline	- 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

Name	Time	Method
- The type of soft tissue reconstruction	baseline