Neuromuscular ScoliosisWVNCT03000010
Wound Vac Bandage Comparison After Spinal Fusion
A study testing Incisional Wound Vac and Standard Bandage in people with Neuromuscular Scoliosis, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of incisional vacuum-assisted closure (VAC) therapy in the prevention of infection after posterior spinal fusion for pediatric neuromuscular scoliosis, in comparison to a regular gauze bandage. Read more about this study
- Who is it for?
- Ages 0 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Scoliosis
- What is being tested?
- Incisional Wound Vac and Standard Bandage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2012to 17 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 0 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- any patient 17 years and younger
- neuromuscular scoliosis undergoing posterior spinal fusion
Who cannot join
- idiopathic and congenital scoliosis
- any type of spine surgery other than posterior spinal fusion (eg. vertical expandable prosthetic titanium rib placement, growing rod placement, anterior spinal fusion)
- intraoperative dural tear
- documented allergy to adhesive dressings
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incisional Vacuum-assisted Closure Therapy After Posterior Spinal Fusion for Pediatric Neuromuscular Scoliosis
The purpose of this study is to evaluate the effectiveness of incisional vacuum-assisted closure (VAC) therapy in the prevention of infection after posterior spinal fusion for pediatric neuromuscular scoliosis, in comparison to a regular gauze bandage.
Read the detailed description
A prospective randomized controlled study: Patients undergoing posterior spinal fusion will be randomized to a standard postoperative dressing versus an incisional VAC dressing. Both groups will have hematocrit, total lymphocyte count, and albumin checked preoperatively to assess nutritional status, drawn at the same time as standard preoperative labs during history and physical visit. Both groups will undergo standard wound closure and dressing application before breaking the sterile field. The incisional VAC group will undergo placement of an Adaptic dressing over the incision. A standard VAC sponge will be placed and secured with adhesive dressing, and a suction tube will be connected to a VAC machine set to 75 mmHg of continuous suction. The incisional VAC will be left in place for 72 hours postoperatively. Remainder of postoperative care will follow our standard posterior spinal fusion protocol and will be identical in both groups. Patients will be followed for a minimum of 2 years postoperatively.
- Conditions
- Neuromuscular Scoliosis
- Being tested
- Incisional Wound Vac, Standard Bandage
- Keywords
- Wound Vac, Neuromuscular Scoliosis, Posterior Spinal Fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incisional Wound VacDevice
Also called Incisional vacuum-assisted closure therapy
Standard BandageOther
Also called Gauze Bandage, Gauze
| Study group | Role | What they receive |
|---|---|---|
| Incisional Wound Vac | Active comparator | We will attach sponges and a suction tube to the incision after surgery. We will leave it on for 72 hours. From then on, patients will get the care that patients normally get after spinal fusion surgery. Receives: Device: Incisional Wound Vac |
| Normal Gauze Bandage Group | Active comparator | We will cover patients incision with regular gauze bandages. These are the bandages that patients normally get after spinal fusion surgery. They will be left on for 72 hours. Receives: Other: Standard Bandage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Wound Dehiscence or Infection
Participants with wound dehiscence or infection requiring unplanned dressing changes, antibiotics, or surgery
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study start16 Jul 2012
- Primary completion17 Jul 2020
- Study completion17 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neuromuscular ScoliosisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, G Ying Li, University of Michigan
- Investigators
- Ying G Li, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000010
- Sponsor's protocol ID
- HUM00064814
- Acronym
- WV
- Status last verified
- Jun 2021
- First submitted
- 18 Dec 2016
- Last updated
- 28 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incisional Vacuum-assisted Closure Therapy After Posterior Spinal Fusion for Pediatric Neuromuscular Scoliosis
- ClinicalTrials.gov ID
- NCT03000010
- Acronym / sponsor ID
- WV / HUM00064814
- Conditions
- Neuromuscular Scoliosis
- Keywords
- Wound Vac, Neuromuscular Scoliosis, Posterior Spinal Fusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 16 Jul 2012 (actual)
- Primary completion
- 17 Jul 2020 (actual)
- Study completion
- 17 Jul 2020 (actual)
- First posted
- 21 Dec 2016 (estimated)
- Results
- Posted 28 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness of incisional vacuum-assisted closure (VAC) therapy in the prevention of infection after posterior spinal fusion for pediatric neuromuscular scoliosis, in comparison to a regular gauze bandage.
Detailed description
A prospective randomized controlled study: Patients undergoing posterior spinal fusion will be randomized to a standard postoperative dressing versus an incisional VAC dressing. Both groups will have hematocrit, total lymphocyte count, and albumin checked preoperatively to assess nutritional status, drawn at the same time as standard preoperative labs during history and physical visit. Both groups will undergo standard wound closure and dressing application before breaking the sterile field. The incisional VAC group will undergo placement of an Adaptic dressing over the incision. A standard VAC sponge will be placed and secured with adhesive dressing, and a suction tube will be connected to a VAC machine set to 75 mmHg of continuous suction. The incisional VAC will be left in place for 72 hours postoperatively. Remainder of postoperative care will follow our standard posterior spinal fusion protocol and will be identical in both groups. Patients will be followed for a minimum of 2 years postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incisional Wound Vac | Active comparator | Device: Incisional Wound VacWe will attach sponges and a suction tube to the incision after surgery. We will leave it on for 72 hours. From then on, patients will get the care that patients normally get after spinal fusion surgery. |
| Normal Gauze Bandage Group | Active comparator | Other: Standard BandageWe will cover patients incision with regular gauze bandages. These are the bandages that patients normally get after spinal fusion surgery. They will be left on for 72 hours. |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- any patient 17 years and younger
- neuromuscular scoliosis undergoing posterior spinal fusion
Key exclusion criteria (4 listed)
- idiopathic and congenital scoliosis
- any type of spine surgery other than posterior spinal fusion (eg. vertical expandable prosthetic titanium rib placement, growing rod placement, anterior spinal fusion)
- intraoperative dural tear
- documented allergy to adhesive dressings
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 |
|---|---|---|
| Incisional Wound VacAlso: Incisional vacuum-assisted closure therapy | Device | Incisional Wound Vac |
| Standard BandageAlso: Gauze Bandage, Gauze | Other | Normal Gauze Bandage Group |
Primary outcome
Number of Participants With Wound Dehiscence or Infection
Time frame: 2 years
Participants with wound dehiscence or infection requiring unplanned dressing changes, antibiotics, or surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ying G Li, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incisional Wound Vac and Standard Bandage in people with Neuromuscular Scoliosis, run by University of Michigan at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 28 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Wound Dehiscence or Infection (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2021.