Obesity, Surgical Site Infections, Wound Complications, Complications; Cesarean Section
Conditions
Keywords
negative pressure wound therapy, cesarean delivery
Brief summary
The investigators aim to show that single use negative pressure dressings can decrease the rate of wound complications in obese women (BMI \> 40 kg/m2) undergoing cesarean delivery at a tertiary medical center by randomizing women to receive either a single use negative pressure dressing or the standard dressing after cesarean delivery.
Detailed description
Subjects admitted to L+D for obstetric or medical indications at a tertiary medical center with a BMI \> 40 kg/m2 will be asked to participate in a study on post surgical dressings and wound outcomes if they undergo cesarean delivery. Subjects will be randomized to either study arm at the time of fascial closure during cesarean delivery. Post operative care will not be altered. Incisions will be evaluated prior to hospital discharge. Subjects will present for a wound evaluation 2 weeks post operatively, and receive phone calls to assess outcomes at both 2 and 6 weeks post operatively.
Interventions
DEVICEStandard Dressing
Patients are randomized to the standard dressing at the time of fascial closure.
DEVICENegative Pressure Wound Therapy Dressing
Patients are randomized to the NPWT at the time of fascial closure.
Sponsors
Tufts Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* BMI \>40 kg/m2 undergoing cesarean delivery for any cause and willing to have a 2 week post operative follow-up for a wound evaluation at Tufts Medical Center.
Exclusion criteria
* Women less than age 18, women with an active infection in the location of Pfannenstiel skin incision, women not willing to come to Tufts Medical Center for a wound evaluation 2 weeks post operatively, women who do not have height and weight information available, and women with a BMI \< 40 kg/m2 will be excluded from this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Composite Outcome of the Presence of Wound Complications Diagnosed by the Two Week Post Operative Appointment | 2 weeks post partum/post operative period | Composite outcome of wound complications, defined as the presence of any of the following: superficial, deep, and organ space surgical site infections (SSIs), skin blisters around the incision, scar separation \>1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | 2 weeks post partum/post operative period | The presence of each the following individual wound complications will be analyzed as separate outcomes: superficial, deep, and organ space SSIs, skin blisters around the incision, scar separation \>1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management. |
| Number of Participants With Composite Outcome of the Presence of Severe Wound Complications Diagnosed by the Two Week Post Operative Appointment | 2 weeks post partum/post operative period | Composite outcome of the presence of one of the following major complications; deep incisional SSIs, scar separation \> 1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital readmission and additional operating room management. |
| Number of Participants With Composite Outcome of the Presence of Wound Complications Diagnosed at a Two Week Post Operative Appointment, or Ascertained Through Patient Phone Calls at 2 and 6 Weeks Post Operatively. | 6 weeks post partum/post operative period | Composite outcome of wound complications, defined as the presence of any of the following: superficial, deep, and organ space surgical site infections (SSIs), skin blisters around the incision, scar separation \>1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management. |
| Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | 6 weeks post partum/post operative period | The presence of each the following individual wound complications will be analyzed as separate outcomes: superficial, deep, and organ space SSIs, skin blisters around the incision, scar separation \>1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management. |
| Number of Participants With Composite Outcome of the Presence of Severe Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Week Post Operatively | 6 weeks post partum/post operative period | Composite outcome of the presence of one of the following major complications; deep incisional SSIs, scar separation \> 1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital readmission and additional operating room management. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Dressing Women will be randomized to receive the standard dressing (sterile gauze, non absorbent sterile gauze, and a waterproof bandage) at the time of fascial closure in a cesarean delivery.
Standard Dressing: Patients are randomized to the standard dressing at the time of fascial closure. | 55 |
| Negative Pressure Wound Therapy Dressing Women will be randomized to receive the Negative Pressure Wound Therapy (NPWT) dressing at the time of fascial closure in a cesarean delivery.
Negative Pressure Wound Therapy Dressing: Patients are randomized to the NPWT at the time of fascial closure. | 55 |
| Total | 110 |
Baseline characteristics
| Characteristic | Standard Dressing | Negative Pressure Wound Therapy Dressing | 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 | 55 Participants | 55 Participants | 110 Participants |
| Age, Continuous | 31.2 years STANDARD_DEVIATION 5.3 | 31.5 years STANDARD_DEVIATION 6.3 | 31.3 years STANDARD_DEVIATION 5.8 |
| Body Mass Index | 47.8 kg/m2 STANDARD_DEVIATION 6.9 | 49.3 kg/m2 STANDARD_DEVIATION 6.6 | 48.6 kg/m2 STANDARD_DEVIATION 6.8 |
| chronic steroid use | 1 Participants | 0 Participants | 1 Participants |
| current smoker | 2 Participants | 4 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 14 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants | 41 Participants | 88 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| former smoker | 9 Participants | 6 Participants | 15 Participants |
| gestational age | 36.4 weeks STANDARD_DEVIATION 3.3 | 37.4 weeks STANDARD_DEVIATION 3.1 | 36.9 weeks STANDARD_DEVIATION 3.2 |
| gestational diabetes | 20 Participants | 15 Participants | 35 Participants |
| Insulin use | 13 Participants | 15 Participants | 28 Participants |
| Oral Hypoglycemic agent use | 3 Participants | 2 Participants | 5 Participants |
| pregestational diabetes | 6 Participants | 9 Participants | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 10 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) White | 38 Participants | 41 Participants | 79 Participants |
| Region of Enrollment United States | 55 Participants | 55 Participants | 110 Participants |
| Sex: Female, Male Female | 55 Participants | 55 Participants | 110 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 | 0 / 55 | 0 / 55 |
| other Total, other adverse events | 0 / 55 | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 | 0 / 55 |
Outcome results
Primary
Number of Participants With Composite Outcome of the Presence of Wound Complications Diagnosed by the Two Week Post Operative Appointment
Composite outcome of wound complications, defined as the presence of any of the following: superficial, deep, and organ space surgical site infections (SSIs), skin blisters around the incision, scar separation \>1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management.
Time frame: 2 weeks post partum/post operative period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Dressing | Number of Participants With Composite Outcome of the Presence of Wound Complications Diagnosed by the Two Week Post Operative Appointment | 14 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Composite Outcome of the Presence of Wound Complications Diagnosed by the Two Week Post Operative Appointment | 10 Participants |
Secondary
Number of Participants With Composite Outcome of the Presence of Severe Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Week Post Operatively
Composite outcome of the presence of one of the following major complications; deep incisional SSIs, scar separation \> 1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital readmission and additional operating room management.
Time frame: 6 weeks post partum/post operative period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Dressing | Number of Participants With Composite Outcome of the Presence of Severe Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Week Post Operatively | 12 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Composite Outcome of the Presence of Severe Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Week Post Operatively | 5 Participants |
Secondary
Number of Participants With Composite Outcome of the Presence of Severe Wound Complications Diagnosed by the Two Week Post Operative Appointment
Composite outcome of the presence of one of the following major complications; deep incisional SSIs, scar separation \> 1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital readmission and additional operating room management.
Time frame: 2 weeks post partum/post operative period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Dressing | Number of Participants With Composite Outcome of the Presence of Severe Wound Complications Diagnosed by the Two Week Post Operative Appointment | 11 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Composite Outcome of the Presence of Severe Wound Complications Diagnosed by the Two Week Post Operative Appointment | 5 Participants |
Secondary
Number of Participants With Composite Outcome of the Presence of Wound Complications Diagnosed at a Two Week Post Operative Appointment, or Ascertained Through Patient Phone Calls at 2 and 6 Weeks Post Operatively.
Composite outcome of wound complications, defined as the presence of any of the following: superficial, deep, and organ space surgical site infections (SSIs), skin blisters around the incision, scar separation \>1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management.
Time frame: 6 weeks post partum/post operative period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Dressing | Number of Participants With Composite Outcome of the Presence of Wound Complications Diagnosed at a Two Week Post Operative Appointment, or Ascertained Through Patient Phone Calls at 2 and 6 Weeks Post Operatively. | 16 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Composite Outcome of the Presence of Wound Complications Diagnosed at a Two Week Post Operative Appointment, or Ascertained Through Patient Phone Calls at 2 and 6 Weeks Post Operatively. | 11 Participants |
Secondary
Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively
The presence of each the following individual wound complications will be analyzed as separate outcomes: superficial, deep, and organ space SSIs, skin blisters around the incision, scar separation \>1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management.
Time frame: 6 weeks post partum/post operative period
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | superficial SSI | yes | 7 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | superficial SSI | no | 48 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | deep SSI | yes | 0 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | deep SSI | no | 55 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | organ space SSI | yes | 0 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | organ space SSI | no | 55 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | skin blisters | yes | 5 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | skin blisters | no | 50 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | scar separation | yes | 7 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | scar separation | no | 48 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | seroma w/evacuation | yes | 1 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | seroma w/evacuation | no | 54 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | hematoma w/evacuation | yes | 0 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | hematoma w/evacuation | no | 55 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | wound debridement | yes | 1 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | wound debridement | no | 54 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | hospital readmission | yes | 1 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | hospital readmission | no | 54 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | additional operative room management | yes | 0 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | additional operative room management | no | 55 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | hospital readmission | no | 54 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | superficial SSI | yes | 7 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | seroma w/evacuation | yes | 2 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | superficial SSI | no | 48 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | wound debridement | no | 53 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | deep SSI | yes | 0 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | seroma w/evacuation | no | 53 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | deep SSI | no | 55 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | additional operative room management | no | 54 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | organ space SSI | yes | 0 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | hematoma w/evacuation | yes | 1 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | organ space SSI | no | 55 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | hospital readmission | yes | 1 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | skin blisters | yes | 2 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | hematoma w/evacuation | no | 54 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | skin blisters | no | 53 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | additional operative room management | yes | 1 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | scar separation | yes | 2 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | wound debridement | yes | 2 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | scar separation | no | 53 Participants |
Secondary
Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment
The presence of each the following individual wound complications will be analyzed as separate outcomes: superficial, deep, and organ space SSIs, skin blisters around the incision, scar separation \>1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management.
Time frame: 2 weeks post partum/post operative period
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | superficial SSI | yes | 6 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | superficial SSI | no | 49 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | deep SSI | yes | 0 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | deep SSI | no | 55 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | organ space SSI | yes | 0 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | organ space SSI | no | 55 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | skin blisters | yes | 5 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | skin blisters | no | 50 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | scar separation | yes | 5 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | scar separation | no | 50 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | seroma w/evacuation | yes | 1 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | seroma w/evacuation | no | 54 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | hematoma w/evacuation | yes | 0 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | hematoma w/evacuation | no | 55 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | wound debridement | yes | 1 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | wound debridement | no | 54 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | hospital readmission | yes | 1 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | hospital readmission | no | 54 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | additional operative room management | yes | 0 Participants |
| Standard Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | additional operative room management | no | 55 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | hospital readmission | no | 54 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | superficial SSI | yes | 7 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | seroma w/evacuation | yes | 2 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | superficial SSI | no | 48 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | wound debridement | no | 53 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | deep SSI | yes | 0 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | seroma w/evacuation | no | 53 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | deep SSI | no | 55 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | additional operative room management | no | 54 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | organ space SSI | yes | 0 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | hematoma w/evacuation | yes | 1 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | organ space SSI | no | 55 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | hospital readmission | yes | 1 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | skin blisters | yes | 1 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | hematoma w/evacuation | no | 54 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | skin blisters | no | 54 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | additional operative room management | yes | 1 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | scar separation | yes | 2 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | wound debridement | yes | 2 Participants |
| Negative Pressure Wound Therapy Dressing | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | scar separation | no | 53 Participants |