WoundVac in Obese Patients Undergoing Lumbar Surgery
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/30/2018 |
| Start Date: | October 15, 2018 |
| End Date: | October 15, 2020 |
| Contact: | Leah Y Carreon, MD, MSc |
| Email: | spineresearch@nortonhealthcare.org |
| Phone: | 5029920488 |
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.
to decrease post-operative wound complications in patients with BMI ≥35kg/m2 after posterior
lumbar spine surgery.
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: 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
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
We found this trial at
1
site
Louisville, Kentucky 40202
Principal Investigator: Charles II H Crawford, MD
Phone: 502-992-0488
Click here to add this to my saved trials
