Gynecologic Neoplasms, Obesity, Postoperative Complications
Conditions
Keywords
Wound Healing, Obesity, Gynecologic Surgery, Gynecologic Neoplasms, Surgical Complications
Brief summary
The purpose of the study is to test whether the use of a new wound closure technique can decrease the rates of wound complications in obese cancer patients.
Detailed description
Most gynecologic and many intra-abdominal malignancies are treated with an initial surgical procedure. There has been a dramatic increase in obesity rates in the US with more than one third of US adults being obese (Body Mass Index (BMI) of \> 30kg/m2). There is a direct link between obesity and wound complications following surgery with an increasing BMI leading to increasing rates of complications. Negative pressure wound therapy (NPWT) is a system that utilizes sub-atmospheric pressure to improve wound healing by increasing the formation of granulation tissue. NPWT has been shown to improve outcomes in both the orthopedic and cardiothoracic surgery populations. To date, there is no prospective study evaluating the application of prophylactic NPWT in laparotomy patients. This study will be a randomized clinical trial. Patients will be enrolled at the time of consent for laparotomy for suspected gynecologic malignancy. Participants will be randomized to one of two groups: 1) Standard closure group (control arm): closure of the fascia, subcutaneous tissue and skin per the surgeon's standard method; or 2) NPWT group (study arm): closure of the fascia, subcutaneous tissue and skin per the surgeon's standard method + placement of a negative pressure wound therapy device over the closed incision for 2-3 days, with removal of the device prior to hospital discharge. The rate of wound complications for two groups will be compared.
Interventions
PROCEDUREStandard Wound Closure
The standard surgical closure consists of closure of the fascia with a looped polydioxanone (PDS) suture in a running fashion either in with the use of a mass closure technique or a Smead Jones closure at the discretion of the operating surgeon, closure of the subcutaneous space if \>2 cm deep, followed by staple or suture closure of the skin.
At the close of surgery, the Prevena™ Incision Management System will be placed over the closed incision. It will be removed on post-operative day 2 or 3 as clinically indicated and prior to the patient's discharge from the hospital.
Sponsors
Masonic Cancer Center, University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Known or suspected gynecologic or other abdominal malignancy (such as colorectal, liver, pancreatic, kidney and stomach) for which laparotomy is planned * Obese - defined as a Body Mass Index (BMI) ≥ 35 kg/m2 as calculated in the Epic computer record
Exclusion criteria
* Known true tape allergy * Sensitivity to silver * History of intolerance to Negative Pressure Wound Therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Who Experience Wound Complications (Wound Dehiscence or Infection) | one month after surgery |
Secondary
| Measure | Time frame |
|---|---|
| Time From Surgery to Starting Adjuvant Therapy Among Those With Confirmed Malignancies | up to 20 weeks |
Countries
United States
Participant flow
Pre-assignment details
93 participants originally consented, one withdrew consent and 11 did not return updated HIPAA forms and therefore could not be included in the analysis
Participants by arm
| Arm | Count |
|---|---|
| Standard Wound Closure Standard surgical closure of the fascia and skin. | 38 |
| Negative Pressure Wound Therapy Standard surgical closure as used by the standard of care group plus placement of the Prevena™ Incision Management System over the closed incision. | 43 |
| Total | 81 |
Baseline characteristics
| Characteristic | Standard Wound Closure | Total | Negative Pressure Wound Therapy |
|---|---|---|---|
| Age, Continuous | 58.4 years STANDARD_DEVIATION 9.9 | 59.1 years STANDARD_DEVIATION 10.4 | 59.6 years STANDARD_DEVIATION 11.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 77 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 7 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) White | 34 Participants | 66 Participants | 32 Participants |
| Region of Enrollment United States | 38 participants | 81 participants | 43 participants |
| Sex: Female, Male Female | 38 Participants | 81 Participants | 43 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 / 38 | 0 / 43 |
| other Total, other adverse events | 5 / 38 | 3 / 43 |
| serious Total, serious adverse events | 7 / 38 | 17 / 43 |
Outcome results
Primary
Number of Participants Who Experience Wound Complications (Wound Dehiscence or Infection)
Time frame: one month after surgery
Population: Follow up data is not available for 2 participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Wound Closure | Number of Participants Who Experience Wound Complications (Wound Dehiscence or Infection) | No | 25 Participants |
| Standard Wound Closure | Number of Participants Who Experience Wound Complications (Wound Dehiscence or Infection) | Yes | 12 Participants |
| Negative Pressure Wound Therapy | Number of Participants Who Experience Wound Complications (Wound Dehiscence or Infection) | No | 33 Participants |
| Negative Pressure Wound Therapy | Number of Participants Who Experience Wound Complications (Wound Dehiscence or Infection) | Yes | 9 Participants |
Comparison: Negative Pressure Wound Therapy vs. Standard Wound Closurep-value: 0.27Chi-squared
Comparison: Negative Pressure Wound Therapy vs. Standard Wound Closurep-value: 0.24Regression, Logistic
Secondary
Time From Surgery to Starting Adjuvant Therapy Among Those With Confirmed Malignancies
Time frame: up to 20 weeks
Population: Only those participants who received adjuvant therapies were analyzed in both arms. Rest of the patients didn't have cancer that required subsequent therapies.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Wound Closure | Time From Surgery to Starting Adjuvant Therapy Among Those With Confirmed Malignancies | 37 days |
| Negative Pressure Wound Therapy | Time From Surgery to Starting Adjuvant Therapy Among Those With Confirmed Malignancies | 28 days |