Obesity Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 124 |
Est. completion date | October 15, 2020 |
Est. primary completion date | October 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Norton Leatherman Spine Center | Louisville | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Norton Leatherman Spine Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Within one month after surgery | |
Secondary | Days to dry wound | Number of days after surgery it took to have the wound become dry | One month after surgery |
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