Role of Vacuum in Open Fracture Tibia Grade III Type B

Open Fracture of Tibia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04063111
• Other study ID #: VAC in open fracture tibia
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: April 15, 2022

Study information

• Verified date: August 2019
• Source: Assiut University
• Contact: Albair malaka sedki, Risedent
• Phone: 01024336337
• Email: albairalbair[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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,].

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 15, 2022
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 )

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Open
• Open Fracture of Tibia
• Tibial Fractures

Intervention

Device:
• vacuum 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
CONVENTIONAL DRESSING for wound of open fracture of tibia grade III B

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & 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. Review. Erratum in: J Reconstr Microsurg. 2017 Oct;33(S 01):e1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- 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	- The type of soft tissue reconstruction		baseline