Wound Complication Clinical Trial
Official title:
Prophylactic Wound VACuum Therapy to Decrease Rates of Cesarean Section in the Obese Population
This study will assess whether a negative pressure wound vacuum therapy (NPWT) on closed
incisions decreases the risk of wound complications among obese patients after cesarean
section
All patients having a cesarean section in labor or presenting to the triage unit and
requiring a cesarean section will be eligible
Main study intervention: this involves the use of a negative pressure wound vacuum therapy on
a closed incision.
Objectives To evaluate whether there is a decrease in wound complications among obese
patients who are treated with closed incision NPWT versus standard post cesarean section
wound care protocol.
Primary outcome variable(s) The primary outcome variable is wound complications defined as
any readmission for a wound issue within four weeks of discharge, infection, or wound
breakdown.
Secondary outcome will look at patient quality of life among those with NPWT versus usual
care arm.
A survey addressing pain, breast feeding questions and ability to perform activity of daily
living will be administered during the inpatient stay and at the postpartum visit.
Background Obesity, defined as a body mass index (BMI) 30kg/m2, continues to be a growing
epidemic in the United States. According to National Center for Health Statistics Data1,
almost one third of adults and 17% of youth were obese in 2009-2010. Furthermore,
non-Hispanic Blacks have the age-adjusted rates of obesity (49.5%). In a study by Chu et al
analyzing data from 26 states in the Pregnancy Risk Assessment Monitoring System (PRAMS)
database, 20% of women who delivered were obese and in certain ethnic and insurance
subgroups, the rates were as high as 33%. In 2008, according to reports by the Pennsylvania
State statistics, the rates of obesity in the city of Philadelphia were as high as 64%.
Multiple studies have demonstrated the increased risks for diabetes, hypertension and adverse
pregnancy outcomes (APO) during pregnancy in the obese population. In addition, obesity is a
well established independent risk factor for the development of a wound complication or
infection after a cesarean delivery, with rates ranging from 10-15% . Certain measures such
as antibiotic prophylaxis and closure of the subcutaneous space are techniques that have
demonstrated a decreased incidence of wound disruption. Currently no randomized controlled
trials have looked at the effects of surgical approach or choice of abdominal incision in the
obese or extremely obese woman undergoing cesarean delivery. However, the few retrospective
studies that have addressed this issue have demonstrated mixed results. Given the paucity of
randomized controlled trials evaluating the prevention of wound complications in obese women
undergoing cesarean delivery, a recent review by Tipton emphasized the necessity for such
trials to evaluate methods with which to improve postoperative wound care and healing in this
high risk cohort. In the past decade, negative pressure wound therapy (NPWT) has become
accepted in the treatment of expediting healing of open wounds 15-18. NPWT is a method in
which a vacuum device is placed on the wound in order to remove excess interstitial fluid,
increase tissue vascularity, decrease bacterial colonization, and place mechanical stress on
adjacent wound edges which aids in wound contractility and closure. Therefore, the positive
effects of NPWT on open wounds have been well studied and established. Recent studies have
been performed to assess a potential effect of NPWT on closed incisions non-obstetric fields.
A recent study by Grauhan et al compared the effects of NPWT over closed sternotomy incisions
in obese patients compared to conventional sterile wound dressing and noted a significant
reduction in the rates of wound infection in those treated with NPWT.
Another study by Vargo assessed the effects of NPWT on closed incisions in patients
undergoing abdominal therapy compared to a historical control also noted a decreased wound
infection rate and no evidence of skin necrosis. In contrast, a recent study by Masden et al.
looked at rates of infection and dehiscence in patients with multiple comorbidities status
post predominantly lower extremity wounds and did not appreciate a difference between the
NPWT group and dry dressing group24. Therefore, the need for further studies assessing the
benefits of NPWT on various anatomical sites has been clearly established.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01698372 -
Negative Pressure Dressing After Saphenous Vein Harvest
|
Phase 1 | |
Not yet recruiting |
NCT03872544 -
Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
|
||
Terminated |
NCT03148496 -
Tissue Reinforcement of Incisional Closure Among High Risk Patients
|
N/A | |
Enrolling by invitation |
NCT03880188 -
Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
|
||
Terminated |
NCT03269968 -
Use of Negative Pressure Wound Therapy in Morbidly Obese Women After Cesarean Delivery
|
N/A | |
Active, not recruiting |
NCT03390764 -
Hernia After Colorectal Cancer Surgery
|
N/A | |
Completed |
NCT03938584 -
The Effect of Vitamin C on Wound Healing In Mandibular Fracture Patients
|
N/A | |
Completed |
NCT05142956 -
Smoking Increases the Risk of Postoperative Wound Complications: a Propensity Score-matched Cohort Study
|
||
Recruiting |
NCT03527433 -
Comparing Wound Complications After Elective Abdominal Surgery Using Two Closure Techniques
|
N/A | |
Completed |
NCT03477682 -
Postoperative Management of Groin Flaps for Vascular Coverage
|
N/A | |
Not yet recruiting |
NCT02967627 -
VAC Dressings for Colorectal Resections
|
N/A | |
Terminated |
NCT02838017 -
Tissue Adhesive vs. Sterile Strips After Cesarean Delivery
|
N/A | |
Completed |
NCT04735133 -
The Effect of Wound Problems Wound Dressing in Patients With Colorectal Cancer Surgery
|
N/A | |
Completed |
NCT03942575 -
The Risk of Postoperative Wound Complications Following the Use of Negative Pressure Wound Therapy in Patients Undergoing Mastectomy
|
N/A | |
Not yet recruiting |
NCT06191159 -
Cosmetic Outcome of Electrocautery, Scalpel and PEAK PlasmaBlade for Surgical Breast Incisions
|
N/A | |
Terminated |
NCT02355691 -
Improvement in Wound Healing With Negative Pressure Wound Therapy for Postoperative Total Hip Arthroplasty
|
N/A | |
Completed |
NCT01977612 -
Randomized Clinical Trial of Skin Closure With Staples Versus Suture
|
Phase 2 | |
Completed |
NCT03061903 -
Closed Incision Negative Pressure Therapy vs Standard of Care
|
N/A | |
Recruiting |
NCT03948412 -
Negative Pressure Wound Therapy (PREVENA) Versus Standard Dressings for Incision Management After Renal Transplant
|
N/A | |
Not yet recruiting |
NCT06337292 -
Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures: A Multicenter Randomized Controlled Trial
|
Phase 3 |