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The purpose of this study is to compare outcomes between incisional negative-pressure wound vacuum-assisted closure (VAC) therapy versus conventional dressings following abdominal surgery.
This study will prospectively compare rates of wound complications using incisional negative pressure wound therapy versus conventional dressings following abdominal reconstruction.
Patients will undergo abdominal surgery (panniculectomy, abdominoplasty, ventral hernia repair, or autologous flap reconstruction using abdominal donor tissue). Following closure of the incision, patients will either have a gauze dressing placed over the incision (control group), or incisional vacuum-assisted closure (VAC) therapy. The dressing will be removed over a time period of 2 to 5 days after surgery. The gauze dressing will be removed at 2 days and the wound VAC will be removed at 5 days. After this time, the wound will be assessed for signs of infection, seroma, hematoma, skin and fat necrosis, skin dehiscence, and hernia during the follow-up appointments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vacuum-assisted closure (VAC) therapy | Experimental | Following closure of the incision, patients will have incisional vacuum-assisted closure (VAC) therapy performed. |
|
| Gauze dressing | Active Comparator | Following closure of the incision, patients will either have a gauze dressing placed over the incision. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vacuum-assisted closure (VAC) therapy | Procedure | Following closure of the incision, patients will either have a gauze dressing placed over the incision (control group), or incisional vacuum-assisted closure (VAC) therapy. The dressing will be removed over a time period of 2 to 5 days after surgery. The gauze dressing will be removed at 2 days and the wound VAC will be removed at 5 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative Wound Complications | Post-operative wound complications (infection, seroma, hematoma, skin and fat necrosis, skin dehiscence, and hernia) will be assessed at 2 days for gauze patients and at 5 days for VAC patients. This outcome will be assessed based on the clinical examination by the surgeon following removal of the wound dressing. There is no defined assessment tool for this outcome as clinical observation is the standard in these procedures. | Between 2 and 5 days following surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Persing, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University, Section of Plastic Surgery | New Haven | Connecticut | 06511 | United States |
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| D013812 | Therapeutics |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
| D019984 | Quality Indicators, Health Care |
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| Gauze dressing | Procedure | Following closure of the incision, patients will either have a gauze dressing placed over the incision (control group), or incisional vacuum-assisted closure (VAC) therapy. The dressing will be removed over a time period of 2 to 5 days after surgery. The gauze dressing will be removed at 2 days and the wound VAC will be removed at 5 days. |
|
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| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |