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Continuation was futile per calculation recommend by data & safety monitoring committee
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| Name | Class |
|---|---|
| Southern New Hampshire Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vacuum-assisted closure (VAC) | Experimental | Prevena (VAC) device |
|
| Standard sterile dressing | Active Comparator | Standard sterile dressing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vacuum-assisted closure | Device | Prevena (VAC) device at the time of primary closure for a cesarean section, left in place for 5-7 days postoperatively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative wound infection | Determine number of post-operative wound infections | 6 weeks post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of seroma | Calculate incidence of seroma | 6 weeks post-operative |
| Rate of hematoma | Calculate incidence of hematoma | 6 weeks post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zachary Spalding, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Kristina Wihbey, MD | Dartmouth-Hitchcock Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States | ||
| Women's Care of Nashua |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29995726 | Derived | Wihbey KA, Joyce EM, Spalding ZT, Jones HJ, MacKenzie TA, Evans RH, Fung JL, Goldman MB, Erekson E. Prophylactic Negative Pressure Wound Therapy and Wound Complication After Cesarean Delivery in Women With Class II or III Obesity: A Randomized Controlled Trial. Obstet Gynecol. 2018 Aug;132(2):377-384. doi: 10.1097/AOG.0000000000002744. |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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|
| Standard sterile dressing | Device | Standard sterile dressing at the time of primary closure for a cesarean section, left in place for 1-2 days postoperatively. |
|
| Deep and superficial infection | Calculate incidence of deep and superficial infection | 6 weeks post-operative |
| Readmission for infection | Calculate incidence of readmission to hospital for infection due to cesarean incision | 6 weeks post-operative |
| Re-operation | Calculate incidence of re-operation to patients enrolled in study | 6 weeks post-operative |
| Antibiotic treatment | Calculate incidence of need for antibiotic treatment for enrolled patients | 6 weeks post-operative |
| Nashua |
| New Hampshire |
| 03060-3922 |
| United States |
| Dartmouth-Hitchcock Nashua | Nashua | New Hampshire | 03060 | United States |
| Southern New Hampshire Medical Center | Nashua | New Hampshire | 03060 | United States |
| D013568 |
| Pathological Conditions, Signs and Symptoms |