ObesityNCT03688438
WoundVac in Obese Patients Undergoing Lumbar Surgery
A study testing Closed-Incision Negative-Pressure Therapy in people with Obesity and Lumbar Spine Surgery, run by Norton Leatherman Spine Center at 1 site in United States.
Trial summary
This is an open label, randomized clinical trial of Closed-Incision Negative-Pressure Therapy to decrease post-operative wound complications in patients with BMI ≥35kg/m2 after posterior lumbar spine surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Lumbar Spine Surgery
- What is being tested?
- Closed-Incision Negative-Pressure Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2018to 15 Oct 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged ≥18 years old
- Patients undergoing posterior lumbar fusion with or without interbody fusion
- Body Mass Index of ≥35kg/m2
- Able to provide Informed Consent
- No prior lumbar spine surgery
Who cannot join
- Presence of skin infection or any systemic infection
- Known allergy or sensitivity to silver or acrylic adhesive
- Fragile peri-incisional skin
- Patients on anti-coagulation and/or platelet aggregation inhibitors
Trial locations and contacts
1 site in 1 country.
United States1 site
Norton Leatherman Spine Center
Louisville, Kentucky, 40202
Leah Y Carreon, MD, MSc, 502-992-0488 ext. 14139, spineresearch@nortonhealthcare.org
Kelly R Bratcher, RN, 5029920488 ext. 14161, kelly.bratcher2@nortonhealthcare.org
About this study
Official title: Post Operative Wound Complications in Patients With BMI ≥35kg/m2 After Posterior Lumbar Spine Surgery: a Randomized Clinical Trial of Closed-Incision Negative-Pressure Therapy
This is an open label, randomized clinical trial of Closed-Incision Negative-Pressure Therapy to decrease post-operative wound complications in patients with BMI ≥35kg/m2 after posterior lumbar spine surgery.
Read the detailed description
Methods:
Study Design: Prospective open-label randomized clinical trial of CINPT in obese patients. Subjects will be randomized in a 1:1 to Standard of Care (SOC) and CINPT.
Study Arms: (1) Standard of Care (2) CINPT Sample Size: Based on 30% incidence of wound complications in obese patients undergoing lumbar spine surgery, a sample size of 124 (62 in each cohort) will be needed to detect a decreased incidence of 10% with an α of 0.05 and β of 0.2.
Randomization: Randomization will be done with varying blocks of 4, 6 and 8 using opaque sealed envelopes.
Procedures: All patients will receive standard pre operative prophylactic antibiotics with 2g - 3g Cefazolin or 1g Clindamycin (if patient has known penicillin allergy) based on weight 60 min before incision is made. They will be clipped if needed before being prepped. Each patient will be prepped with alcohol and then either duraprep, chloraprep, or betadine. After the procedure is complete, a subfascial and subcutaneous closed suction drain will be placed in the wound prior to closure. 1 to 3 gram of Vancomycin powder will be placed in the wound. The wound is closed with #1vicryl for the fascial layer followed by 2-0 Vicryl for the subcutaneous layer followed by 3-0 or 4-0 monocryl. In the SOC group, skin glue, Steri-strips, sterile gauze and Tegaderm will be applied to the wound. In the CINPT group, a CINPT dressing will be placed and attached to a compact portable negative pressure unit to deliver 125mmHg continuous pressure for 5 to 7 days. All patients will receive standard wound care instructions before hospital discharge. Patients will return to the clinic in 6±1 days for a wound check and removal of the CINPT.
Primary endpoint: The primary endpoint is the occurrence of a wound complication. A wound complication can include a local inflammatory reaction, wound dehiscence, skin blistering/necrosis, stitch abscess or Incision and drainage for hematoma seroma, deep or superficial infection
- Conditions
- Obesity, Lumbar Spine Surgery
- Being tested
- Closed-Incision Negative-Pressure Therapy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-Incision Negative-Pressure TherapyDevice
Also called WoundVac
A foam or gauze dressing is put directly on the wound. This foam acts as a filter to keep any large particles (such as blood clots or dead, sloughed off tissue) from clogging the vacuum system. A clear, occlusive, adhesive film covers and seals the dressing and wound, creating an airtight seal. A drainage tube leads from under the adhesive film and connects to a portable vacuum pump. This pump removes air pressure over the wound. The pump is programmed for strength of suction, amount of time it is to be applied and if it is to be intermittent or continuous. A chamber on the pump collects drainage and moisture is drawn away from the wound site.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Standard of care wound closure and dressing No active interventions |
| WoundVAC (CINPT) | Experimental | Closed-Incision Negative-Pressure Therapy Receives: Device: Closed-Incision Negative-Pressure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of wound complication
A wound complication can include a local inflammatory reaction, wound dehiscence, skin blistering/necrosis, stitch abscess or Incision and drainage for hematoma seroma, deep or superficial infection
Measured: Within one month after surgery
Secondary outcomes (1)
Days to dry wound
Number of days after surgery it took to have the wound become dry
Measured: One month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start15 Oct 2018 (estimated)
- Primary completion15 Oct 2019 (estimated)
- Study completion15 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Model description
- Two study arms: (1) Standard of Care and (2) WoundVac
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norton Leatherman Spine Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles II H Crawford, MD, Principal investigator, Norton Leatherman S[ine Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688438
- Sponsor's protocol ID
- 18.1023
- Status last verified
- Sep 2018
- First submitted
- 26 Sep 2018
- Last updated
- 28 Sep 2018
- Results posted
- No
- 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 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Operative Wound Complications in Patients With BMI ≥35kg/m2 After Posterior Lumbar Spine Surgery: a Randomized Clinical Trial of Closed-Incision Negative-Pressure Therapy
- ClinicalTrials.gov ID
- NCT03688438
- Acronym / sponsor ID
- 18.1023
- Conditions
- Obesity, Lumbar Spine Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Norton Leatherman Spine CenterUniversity, hospital or other
- Study start
- 15 Oct 2018 (estimated)
- Primary completion
- 15 Oct 2019 (estimated)
- Study completion
- 15 Oct 2020 (estimated)
- First posted
- 28 Sep 2018 (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.
This is an open label, randomized clinical trial of Closed-Incision Negative-Pressure Therapy to decrease post-operative wound complications in patients with BMI ≥35kg/m2 after posterior lumbar spine surgery.
Detailed description
Methods:
Study Design: Prospective open-label randomized clinical trial of CINPT in obese patients. Subjects will be randomized in a 1:1 to Standard of Care (SOC) and CINPT.
Study Arms: (1) Standard of Care (2) CINPT Sample Size: Based on 30% incidence of wound complications in obese patients undergoing lumbar spine surgery, a sample size of 124 (62 in each cohort) will be needed to detect a decreased incidence of 10% with an α of 0.05 and β of 0.2.
Randomization: Randomization will be done with varying blocks of 4, 6 and 8 using opaque sealed envelopes.
Procedures: All patients will receive standard pre operative prophylactic antibiotics with 2g - 3g Cefazolin or 1g Clindamycin (if patient has known penicillin allergy) based on weight 60 min before incision is made. They will be clipped if needed before being prepped. Each patient will be prepped with alcohol and then either duraprep, chloraprep, or betadine. After the procedure is complete, a subfascial and subcutaneous closed suction drain will be placed in the wound prior to closure. 1 to 3 gram of Vancomycin powder will be placed in the wound. The wound is closed with #1vicryl for the fascial layer followed by 2-0 Vicryl for the subcutaneous layer followed by 3-0 or 4-0 monocryl. In the SOC group, skin glue, Steri-strips, sterile gauze and Tegaderm will be applied to the wound. In the CINPT group, a CINPT dressing will be placed and attached to a compact portable negative pressure unit to deliver 125mmHg continuous pressure for 5 to 7 days. All patients will receive standard wound care instructions before hospital discharge. Patients will return to the clinic in 6±1 days for a wound check and removal of the CINPT.
Primary endpoint: The primary endpoint is the occurrence of a wound complication. A wound complication can include a local inflammatory reaction, wound dehiscence, skin blistering/necrosis, stitch abscess or Incision and drainage for hematoma seroma, deep or superficial infection
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two study arms: (1) Standard of Care and (2) WoundVac
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Standard of care wound closure and dressing No active interventions |
| WoundVAC (CINPT) | Experimental | Device: Closed-Incision Negative-Pressure TherapyClosed-Incision Negative-Pressure Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients aged ≥18 years old
- Patients undergoing posterior lumbar fusion with or without interbody fusion
- Body Mass Index of ≥35kg/m2
- Able to provide Informed Consent
- No prior lumbar spine surgery
Key exclusion criteria (4 listed)
- Presence of skin infection or any systemic infection
- Known allergy or sensitivity to silver or acrylic adhesive
- Fragile peri-incisional skin
- Patients on anti-coagulation and/or platelet aggregation inhibitors
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 |
|---|---|---|
| Closed-Incision Negative-Pressure TherapyAlso: WoundVacA foam or gauze dressing is put directly on the wound. This foam acts as a filter to keep any large particles (such as blood clots or dead, sloughed off tissue) from clogging the vacuum system. A clear, occlusive, adhesive film covers and seals the dressing and wound, creating an airtight seal. A drainage tube leads from under the adhesive film and connects to a portable vacuum pump. This pump removes air pressure over the wound. The pump is programmed for strength of suction, amount of time it is to be applied and if it is to be intermittent or continuous. A chamber on the pump collects drainage and moisture is drawn away from the wound site. | Device | WoundVAC (CINPT) |
Primary outcome
Incidence of wound complication
Time frame: Within one month after surgery
A wound complication can include a local inflammatory reaction, wound dehiscence, skin blistering/necrosis, stitch abscess or Incision and drainage for hematoma seroma, deep or superficial infection
1 secondary outcome
Days to dry wound
Time frame: One month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- 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.
Charles II H Crawford, MD principal investigator
Norton Leatherman S[ine Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed-Incision Negative-Pressure Therapy in people with Obesity and Lumbar Spine Surgery, run by Norton Leatherman Spine Center 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 5 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: status not confirmed, as of the sponsor's last update on 28 Sep 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leah Y Carreon, MD, MSc (5029920488 ext. 14139, spineresearch@nortonhealthcare.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of wound complication (time frame: Within one month after surgery). 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 Sep 2018.