Spinal DeformityNCT01759381
Incisional Negative Pressure Wound Therapy
A study testing Negative pressure wound therapy (NPWT) in people with Spinal Deformity, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the outcome of incisional negative pressure wound therapy in preventing surgical site infections and wound complications (dehiscence) in high-risk patients undergoing complex spinal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Deformity
- What is being tested?
- Negative pressure wound therapy (NPWT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jun 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >/= 18 years of age
- >/= 3 level instrumented thoracic, lumbar, or thoracolumbar spinal fusion
Who cannot join
- < 18 years of age
- < 3 level instrumented thoracic, lumbar, or thoracolumbar spinal fusion
- Spinal infection at time of surgery
- History of immunosuppression or chronic systemic infection
- Pregnancy
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: The Efficacy of Negative Pressure Wound Therapy (NPWT) in the Postoperative Management of Complex Spinal Surgeries: A Randomized Outcomes Study.
The purpose of this study is to evaluate the outcome of incisional negative pressure wound therapy in preventing surgical site infections and wound complications (dehiscence) in high-risk patients undergoing complex spinal surgery.
Read the detailed description
This randomized, controlled study will compare the outcomes of NPWT versus the outcomes of not using NPWT in post-operative wound management following a complex spinal surgery. The allocation of patients (no NPWT device versus applying an NPWT device) will be determined by computer-generated randomization. The following data will be collected to determine impact on the outcome of wound management (i.e., infection and wound dehiscence): age, gender, body mass index (BMI), dorsal fat, estimated blood loss during the surgical procedure, length of surgery, length of hospital stay, highest peri-operative glucose, medical comorbidities, and history of infection.
- Conditions
- Spinal Deformity
- Being tested
- Negative pressure wound therapy (NPWT)
- Keywords
- Spinal Deformity, Complex Spinal Surgery, Negative Pressure Wound Therapy, Post-Operative Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative pressure wound therapy (NPWT)Device
| Study group | Role | What they receive |
|---|---|---|
| No Negative Pressure Wound Therapy Device | No intervention | This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine. |
| NPWT Arm Therapy | Experimental | This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery. Receives: Device: Negative pressure wound therapy (NPWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Post-operative Infection (NPWT)
The patient will be assessed for signs/symptoms of infection within the 3 month post-operative period.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: PI leaving institution
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 Spinal DeformityStudies of the same condition, open and under way.
- More trials run by Duke 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos A Bagley, M.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759381
- Sponsor's protocol ID
- Pro00040054
- Status last verified
- Jun 2015
- First submitted
- 7 Dec 2012
- Last updated
- 2 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Negative Pressure Wound Therapy (NPWT) in the Postoperative Management of Complex Spinal Surgeries: A Randomized Outcomes Study.
- ClinicalTrials.gov ID
- NCT01759381
- Acronym / sponsor ID
- Pro00040054
- Conditions
- Spinal Deformity
- Keywords
- Spinal Deformity, Complex Spinal Surgery, Negative Pressure Wound Therapy, Post-Operative Infection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI leaving institution
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 3 Jan 2013 (estimated)
- Results
- Posted 2 Jul 2015
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 outcome of incisional negative pressure wound therapy in preventing surgical site infections and wound complications (dehiscence) in high-risk patients undergoing complex spinal surgery.
Detailed description
This randomized, controlled study will compare the outcomes of NPWT versus the outcomes of not using NPWT in post-operative wound management following a complex spinal surgery. The allocation of patients (no NPWT device versus applying an NPWT device) will be determined by computer-generated randomization. The following data will be collected to determine impact on the outcome of wound management (i.e., infection and wound dehiscence): age, gender, body mass index (BMI), dorsal fat, estimated blood loss during the surgical procedure, length of surgery, length of hospital stay, highest peri-operative glucose, medical comorbidities, and history of infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Negative Pressure Wound Therapy Device | No intervention | –This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine. |
| NPWT Arm Therapy | Experimental | Device: Negative pressure wound therapy (NPWT)This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >/= 18 years of age
- >/= 3 level instrumented thoracic, lumbar, or thoracolumbar spinal fusion
Key exclusion criteria (6 listed)
- < 18 years of age
- < 3 level instrumented thoracic, lumbar, or thoracolumbar spinal fusion
- Spinal infection at time of surgery
- History of immunosuppression or chronic systemic infection
- Pregnancy
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 |
|---|---|---|
| Negative pressure wound therapy (NPWT) | Device | NPWT Arm Therapy |
Primary outcome
Number of Participants With Post-operative Infection (NPWT)
Time frame: 3 months
The patient will be assessed for signs/symptoms of infection within the 3 month post-operative period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Carlos A Bagley, M.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative pressure wound therapy (NPWT) in people with Spinal Deformity, run by Duke University 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 6 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: stopped early, as of the sponsor's last update on 2 Jul 2015. 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 2 Jul 2015). 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 Post-operative Infection (NPWT) (time frame: 3 months). 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 2 Jul 2015; AzTrials last refreshed its copy on 30 Oct 2026.