Open Fracture of TibiaNCT04063111
Role of Vacuum in Open Fracture Tibia Grade III Type B
A study testing vacuum assistant closure and CONVENTIONAL DRESSING in people with Open Fracture of Tibia, run by Assiut University.
Trial summary
Evaluate the role of VAC in decreasing the time needed for soft tissue coverage and definitive fixation in open IIIB tibial fractures Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Open Fracture of Tibia
- What is being tested?
- vacuum assistant closure and CONVENTIONAL DRESSING
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2019to 15 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - Gustilo Type III B open fractures of the tibia [10].
- Skeletal mature patients.
Who cannot join
- - 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 locations and contacts
No sites are listed yet.
About this study
Official title: ROLE OF VACUUM ASSISTED CLOSURE IN OPEN TYPE III B TIBIAL FRACTURES
- 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,].
- Conditions
- Open Fracture of Tibia
- Being tested
- vacuum assistant closure, CONVENTIONAL DRESSING
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vacuum assistant closureDevice
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 DRESSINGDevice
CONVENTIONAL DRESSING for wound of open fracture of tibia grade III B
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | Group A will be treated with vacuum assistant closure Receives: Device: vacuum assistant closure |
| group B | Active comparator | Group B will be treated with conventional dressing Receives: Device: CONVENTIONAL DRESSING |
What is being measured
The primary outcome is the main question the study is designed to answer.
- 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
Measured: baseline
Secondary outcomes (1)
- The type of soft tissue reconstruction
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start15 Oct 2019 (estimated)
- Primary completion15 Oct 2021 (estimated)
- Study completion15 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Open Fracture of TibiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albair Malaka Sedki, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063111
- Sponsor's protocol ID
- VAC in open fracture tibia
- Status last verified
- Aug 2019
- First submitted
- 19 Aug 2019
- Last updated
- 21 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 28985633
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROLE OF VACUUM ASSISTED CLOSURE IN OPEN TYPE III B TIBIAL FRACTURES
- ClinicalTrials.gov ID
- NCT04063111
- Acronym / sponsor ID
- VAC in open fracture tibia
- Conditions
- Open Fracture of Tibia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Oct 2019 (estimated)
- Primary completion
- 15 Oct 2021 (estimated)
- Study completion
- 15 Apr 2022 (estimated)
- First posted
- 21 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Device: vacuum assistant closureGroup A will be treated with vacuum assistant closure |
| group B | Active comparator | Device: CONVENTIONAL DRESSINGGroup B will be treated with conventional dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- - Gustilo Type III B open fractures of the tibia [10].
- Skeletal mature patients.
Key exclusion criteria (2 listed)
- - 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 )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vacuum assistant closureExpose 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. | Device | group A |
| CONVENTIONAL DRESSINGCONVENTIONAL DRESSING for wound of open fracture of tibia grade III B | Device | group B |
Primary outcome
- Time for definitive soft tissue coverage
Time frame: baseline
- Evaluate the role of VAC in decreasing the time needed for soft tissue coverage and definitive fixation in open IIIB tibial fractures
1 secondary outcome
- The type of soft tissue reconstruction
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Background: PubMed 28985633Cherubino 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing vacuum assistant closure and CONVENTIONAL DRESSING in people with Open Fracture of Tibia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Albair malaka sedki, Risedent (01024336337, albairalbair@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- Time for definitive soft tissue coverage (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04063111, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.