WoundVac in Obese Patients Undergoing Lumbar Surgery

Norton Leatherman Spine Center

Status: Unknown

Conditions: Lumbar Spine Surgery; Obesity

Treatments: Device: Closed-Incision Negative-Pressure Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03688438

18.1023

Details and patient eligibility

About

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.

Full 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

Enrollment: 124 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

Standard of Care

No Intervention group

Description:

Standard of care wound closure and dressing No active interventions

WoundVAC (CINPT)

Experimental group

Description:

Closed-Incision Negative-Pressure Therapy

Treatment:

Device: Closed-Incision Negative-Pressure Therapy