Surgical Wound Dehiscence, Wound Infection
Conditions
Keywords
Surgical Wound Dehiscence, Wound Infection, Obesity, Cesarean Delivery, Wound Closure, Negative Pressure wound closure
Brief summary
Wound complications after Cesarean section (C-section) are common in obese women. Approximately 25% of obese women having a C-section will have a wound complication. This research study is designed to assess whether applying a source of vacuum (suction) to the wound can reduce the risk of wound complications. The investigators plan to enroll 220 women into the study. Women will be randomly selected to receive standard stitching and stapling of the incision (cut on the abdomen) or closure with stitches, staples and wound suction. Subjects will be seen for follow-up visits in 7-14 days and again at 4-6 weeks after surgery. The number of wound complications in each group will be compared. If the wound suction technique is successful in preventing wound complications, this may substantially reduce pain and suffering in a large number of women undergoing C-section for delivery.
Interventions
PROCEDURENegative pressure wound closure
Applying negative pressure to primary wound closure
PROCEDUREStandard wound closure
Standard wound closure
Sponsors
CAMC Health System
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Undergoing Cesarean delivery. 2. Patient at least 18 years of age. 3. Weight greater than 199 pounds. 4. Depth of subcutaneous tissue (measured from fascia to epidermis) of greater than or equal to 4 centimeters.
Exclusion criteria
1. Weight less or equal to 199 pounds or less than 4 cm of subcutaneous tissue present. 2. Inability to give proper informed consent. 3. Inability to adhere to follow-up provisions of the study (return for 2 post-operative visits at 7-14 days post-op and between 4-6 weeks post-op). 4. Patient less than 18 years of age.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Patients Experiencing a Wound Complication | 6 Weeks post-partum | Superficial or deep space surgical site infection, or any type of wound disruption, including wound hematoma or seroma. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Negative Pressure Wound Closure Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound. | 28 |
| Standard Wound Closure Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples. | 26 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 3 |
Baseline characteristics
| Characteristic | Negative Pressure Wound Closure | Standard Wound Closure | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 26 Participants | 54 Participants |
| Region of Enrollment United States | 28 participants | 26 participants | 54 participants |
| Sex: Female, Male Female | 28 Participants | 26 Participants | 54 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 28 | 10 / 26 |
| serious Total, serious adverse events | 0 / 28 | 0 / 26 |
Outcome results
Primary
Total Number of Patients Experiencing a Wound Complication
Superficial or deep space surgical site infection, or any type of wound disruption, including wound hematoma or seroma.
Time frame: 6 Weeks post-partum
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Negative Pressure Wound Closure | Total Number of Patients Experiencing a Wound Complication | 15 Participants |
| Standard Wound Closure | Total Number of Patients Experiencing a Wound Complication | 10 Participants |