Clinical trial NCT03688438: WoundVac in Obese Patients Undergoing Lumbar Surgery
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Lumbar Spine Surgery
Lead sponsor: Norton Leatherman Spine Center
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two study arms: (1) Standard of Care and (2) WoundVac
Primary purpose: PREVENTION

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of wound complication
timeFrame: Within one month after surgery
Secondary outcomes:
measure: Days to dry wound
timeFrame: One month after surgery
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Norton Leatherman Spine Center
state: Kentucky
Study officials:
affiliation: Norton Leatherman S[ine Center
name: Charles II H Crawford, MD
role: PRINCIPAL_INVESTIGATOR
References: