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Status unknownNCT04063111Updated Aug 21, 2019

Role of Vacuum in Open Fracture Tibia Grade III Type B

An interventional study of vacuum assistant closure and CONVENTIONAL DRESSING in Open Fracture of Tibia, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-21.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

  • Evaluate the role of VAC in decreasing the time needed for soft tissue coverage and definitive fixation in open IIIB tibial fractures
Read the 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,].
02

Conditions studied

  • Open Fracture of Tibia

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03

In context

Fractures, Open

53 studies on the registry are indexed under Fractures, Open; 14 are open to participants now.

This study's planned enrollment of 60 is below the median of 90 across 40 interventional studies indexed under Fractures, Open.

Browse Fractures, Open studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    • Gustilo Type III B open fractures of the tibia [10].
  • Skeletal mature patients.

Exclusion criteria

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 )
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    group A

    Group A will be treated with vacuum assistant closure

    Device: vacuum assistant closure

  • Active comparator
    group B

    Group B will be treated with conventional dressing

    Device: CONVENTIONAL DRESSING

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.

  • DeviceCONVENTIONAL DRESSING

    CONVENTIONAL DRESSING for wound of open fracture of tibia grade III B

06

What researchers measure

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

    Time frame: baseline

Secondary outcomes

  1. - The type of soft tissue reconstruction

    Time frame: baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. Erratum In: J Reconstr Microsurg. 2017 Oct;33(S 01):e1. doi: 10.1055/s-0038-1632386. PubMed 28985633 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2019; primary completion for Oct 2021, 24 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2019
First posted
Aug 21, 2019
StartEst.
Oct 15, 2019
Primary completionEst.
Oct 15, 2021
CompletionEst.
Apr 15, 2022
Last update
Aug 21, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04063111
Lead sponsor
Assiut University
Responsible party
Albair Malaka Sedki (Resident of orthopedic surgery department, Assiut University) — Principal investigator
First posted
Aug 21, 2019
Start date
Oct 15, 2019 (estimated)
Primary completion
Oct 15, 2021 (estimated)
Completion
Apr 15, 2022 (estimated)
Last update
Aug 21, 2019

Study contacts

Albair malaka sedki, Risedent
Contact
albairalbair@yahoo.com
01024336337
OSAMA AHMED FAROUK, Professor
Contact
Osama_farouk@yahoo.com
01222443531

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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