Surgical Wound Infection
Conditions
Brief summary
To study if incisional vacuum-assisted closure can decrease the risk of infection in cesarean section incisions in the obese compared with standard sterile dressing.
Detailed description
The prevalence of obesity (defined as body mass index (BMI, kg/m2) ≥ 30) has significantly increased, affecting approximately 35% of adult females in the United States, according to CDC 2009-2010 statistics. Obesity has a significant impact on pregnancy, including increased need for cesarean section and post-operative wound complications. Infection rates have been reported to be between 10 and 30%. The advent in 1997 of negative pressure therapy (NPT), also known as vacuum assisted closure (VAC), has vastly changed wound care management. Briefly, VAC has been traditionally applied to a chronic wound to create negative or sub-atmospheric pressure, thus promoting wound healing by decreasing edema and increasing blood flow and formation of granulation tissue. Use of this therapy at the time of primary closure of a surgical incision (first trialed in 2006 and termed Incisional VAC) has provided a promising approach to reducing post-operative wound infection. Incisional VAC has been explored primarily in the orthopedic and cardiothoracic fields, but very few studies have examined the use on abdominal incisions, and only one to date on cesarean section incisions.
Interventions
DEVICEVacuum-assisted closure
Prevena (VAC) device at the time of primary closure for a cesarean section, left in place for 5-7 days postoperatively.
Standard sterile dressing at the time of primary closure for a cesarean section, left in place for 1-2 days postoperatively.
Sponsors
Southern New Hampshire Medical Center
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients that have undergone cesarean section for delivery; have a BMI greater or equal to 35. All cases of cesarean section including primary and repeat, scheduled and urgent.
Exclusion criteria
* Patients who deliver vaginally; age less than 18 years old; silver allergy; non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative wound infection | 6 weeks post-operative | Determine number of post-operative wound infections |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of hematoma | 6 weeks post-operative | Calculate incidence of hematoma |
| Deep and superficial infection | 6 weeks post-operative | Calculate incidence of deep and superficial infection |
| Rate of seroma | 6 weeks post-operative | Calculate incidence of seroma |
| Re-operation | 6 weeks post-operative | Calculate incidence of re-operation to patients enrolled in study |
| Antibiotic treatment | 6 weeks post-operative | Calculate incidence of need for antibiotic treatment for enrolled patients |
| Readmission for infection | 6 weeks post-operative | Calculate incidence of readmission to hospital for infection due to cesarean incision |
Countries
United States
Outcome results
None listed