Negative Pressure Wound Therapy in Cesarean Section (NPWTCS)
Primary Purpose
Postoperative Wound Complications
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Negative pressure wound therapy
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Wound Complications
Eligibility Criteria
Inclusion Criteria:
- Pregnant women with BMI > 40 undergoing a cesarean delivery at Parkland Health and Hospital System.
Exclusion Criteria:
- Any patient not meeting inclusion criteria will be deemed ineligible.
- All HIV positive patients will be excluded due to the increased risk of infectious complications in these patients.
- Although patients on anticoagulants can use NPWT, they will be excluded as there may be an increased risk of bleeding in these patients.
according to the wound therapy manufacturer's instructions patients with:
- fragile skin
- allergy to silver or acrylic adhesives
- a malignancy in the wound bed or margins of the wound bed
- non-enteric and unexplored fistulas
- necrotic tissue with eschar present
- exposed arteries, veins, nerves or organs, anastomotic sites, or surgical suction are not candidates for usage of the device.
Sites / Locations
- Parkland Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Negative Pressure Wound Therapy
Standard dressing
Arm Description
After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.
After standard cesarean section completed patients will have standard dressing placed.
Outcomes
Primary Outcome Measures
Number of Participants With Wound Complication
Number of Patients with Wound infection complications: hematoma, seroma, dehiscence, or Surgical Site Infection.
Number of Participants With Classification of Wound Morbidity
Listing of different types of wound morbidity in the 2 cohorts: dehiscence, cellulitis, superficial SSI, deep SSI, organ space SSI
Secondary Outcome Measures
Length of Postoperative Stay
Number of Days in Hospital after Initial Surgery
Length of Stay After Readmission
Number of days in hospital after readmission for wound morbidity
Number of Patients With Emergency Room Visits After Discharge
Number of emergency room visits made after initial discharge by the study (icNPT) and comparison groups.
Number of Patients With Number of Clinic Visits
Number of clinic visits made by patients after surgery concerning wound morbidity per patient
Number of Participants With Morbid Outcomes After Delivery
Number of Participants With Scheduled and Unscheduled Cesarean Section
Cochran Mantel-Hanzel measures used to compare interactions between scheduled and unscheduled cesarean sections stratified by icNPT and standard dressing, for wound morbidity
Number of Participants With Pfannenstiel Versus Midline Abdominal Incisions for Cesarian Section
Cochran-Mantel-Haenzel test for interactions between pfannenstiel and midline abdominal incisions stratified by icNPT vs Standard dressing, for wound morbidity
Number of Patients With Ruptured and Unruptured Membranes Prior to Cesarean Section
Cochran-Mantel-Haenzel measure used to compare interaction in icNPT and Standard dressing stratified by Ruptured vs Unruptured membranes
Number of Patients in Labor Versus no Labor Prior to Cesarean Section
Cochran-Mantel-Haenzel measure used to compare interaction in icNPT and Standard dressing stratified by patients in labor and patients not in labor
Number of Patients With Hypertension Versus no Hypertension
Cochran-Mantel-Haenzel measure used to compare interaction between patients with hypertension versus no hypertension stratified by icNPT versus standard dressing, in wound morbidity
Number of Patients With Insulin Requiring Diabetes Versus no Insulin Requiring Diabetes
Cochran-Mantel-Haenzel measure used to compare interaction in icNPT and Standard wound dressings stratified by women with insulin requiring diabetes and no insulin requiring Diabetes.
Number of Patients With Chorioamnionitis Versus no Chorioamnionitis
Cochran-Mantel-Haenzel measure used to estimate interaction between chorioamnionitis and no chorioamnionitis stratified by icNPT and standard dressing, for wound morbidity
Full Information
NCT ID
NCT02289157
First Posted
October 6, 2014
Last Updated
May 31, 2018
Sponsor
University of Texas Southwestern Medical Center
Collaborators
3M
1. Study Identification
Unique Protocol Identification Number
NCT02289157
Brief Title
Negative Pressure Wound Therapy in Cesarean Section
Acronym
NPWTCS
Official Title
Negative Pressure Wound Therapy in High Risk Patients Undergoing Cesarean
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 27, 2015 (Actual)
Primary Completion Date
August 30, 2016 (Actual)
Study Completion Date
October 21, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
3M
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators propose a prospective, randomized trial evaluating the use of negative pressure wound therapy (NPWT) with high risk obstetrical patients. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators aim to look at all wound complications such as infection and disruption and will be using Prevena incision management system for our NPWT device .
Detailed Description
This will be a prospective, randomized, controlled trial of pregnant women who present for prenatal care at Parkland Health and Hospital System. The participants will be limited to women undergoing a cesarean section who are high risk for wound complications: all patients with a BMI > 40 undergoing cesarean section.
The primary outcome will be wound complication defined as wound disruption or wound infection. A wound disruption will be defined as the partial or complete opening of the deep subcutaneous space, not to include superficial skin separation. Underlying causes will include seroma, hematoma, abscess, and facial dehiscence. Wound infection will be defined as a physician diagnosis of wound infection with erythema and warmth extending beyond the immediate area adjacent to the incision and requiring treatment with antibiotics.
All patients with a BMI > 40 undergoing scheduled cesarean section and patients with a BMI >40 who are admitted in labor will be approached to participate in the study. If patients meeting this criteria undergo cesarean section, they will be randomized to negative pressure wound therapy or a standard dressing. All labor treatment, pre-operative antibiotics, surgical technique, and post-operative care will not differ from current standard of care. All patients randomized will be included in the study.
All study participants will have the thickness of their subcutaneous tissue measured with a sterile ruler. Patients randomized to NPWT will have a negative pressure wound therapy system placed over her incision per the manufacturer's protocol. All patients randomized to standard dressing will have the customary dressing of gauze and surgical tape placed over her incision.
The investigators will be utilizing a single use negative pressure wound therapy system for the study. Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use.
All randomized patients will undergo an examination of their incision by a research physician or nurse prior to discharge. The NPWT will be removed prior to discharge or on post-operative day seven, whichever comes first. All postpartum patients who undergo a cesarean delivery are inpatients until at least post-operative day three and will continue use of NPWT until day of discharge. In patients randomized to a standard dressing, the dressing will be removed prior to discharge per current standard of care.
All randomized patients will also undergo a 2 week post-operative incisional examination by a research physician or nurse at the obstetrical complications clinic. Patients will be followed until 30 days postpartum for any wound complications to include wound infection (superficial and deep), readmission to the hospital, re-operation for wound complications, hematoma, seroma, dehiscence, superficial infection requiring antibiotics, or additional clinical evaluations for wound care in the emergency room or clinic setting. A research physician or nurse will contact each after at least 30 days post-operative to confirm the patients' status and ensure no evaluations, admissions, or interventions were done at outside facilities.
Subjects will exit the study if they are unable to complete the post-operative visit or withdrawal consent for participation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Wound Complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Placebo Controlled Clinical Trial - Open Label
Masking
None (Open Label)
Allocation
Randomized
Enrollment
441 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Negative Pressure Wound Therapy
Arm Type
Experimental
Arm Description
After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.
Arm Title
Standard dressing
Arm Type
No Intervention
Arm Description
After standard cesarean section completed patients will have standard dressing placed.
Intervention Type
Device
Intervention Name(s)
Negative pressure wound therapy
Other Intervention Name(s)
Prevena
Intervention Description
Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.
Primary Outcome Measure Information:
Title
Number of Participants With Wound Complication
Description
Number of Patients with Wound infection complications: hematoma, seroma, dehiscence, or Surgical Site Infection.
Time Frame
Day of surgery to 30 days postoperative
Title
Number of Participants With Classification of Wound Morbidity
Description
Listing of different types of wound morbidity in the 2 cohorts: dehiscence, cellulitis, superficial SSI, deep SSI, organ space SSI
Time Frame
Day of Surgery to 30 days postoperative
Secondary Outcome Measure Information:
Title
Length of Postoperative Stay
Description
Number of Days in Hospital after Initial Surgery
Time Frame
Length of Postoperative Stay
Title
Length of Stay After Readmission
Description
Number of days in hospital after readmission for wound morbidity
Time Frame
After dismissal and readmitted within 30 days for wound morbidity
Title
Number of Patients With Emergency Room Visits After Discharge
Description
Number of emergency room visits made after initial discharge by the study (icNPT) and comparison groups.
Time Frame
Day of surgery to 30 days postoperative
Title
Number of Patients With Number of Clinic Visits
Description
Number of clinic visits made by patients after surgery concerning wound morbidity per patient
Time Frame
Day of surgery to 30 days postoperative
Title
Number of Participants With Morbid Outcomes After Delivery
Time Frame
Day of Surgery to 30 days postoperative
Title
Number of Participants With Scheduled and Unscheduled Cesarean Section
Description
Cochran Mantel-Hanzel measures used to compare interactions between scheduled and unscheduled cesarean sections stratified by icNPT and standard dressing, for wound morbidity
Time Frame
Day of Surgery to 30 days postoperative
Title
Number of Participants With Pfannenstiel Versus Midline Abdominal Incisions for Cesarian Section
Description
Cochran-Mantel-Haenzel test for interactions between pfannenstiel and midline abdominal incisions stratified by icNPT vs Standard dressing, for wound morbidity
Time Frame
Day of Surgery to 30 days postoperative
Title
Number of Patients With Ruptured and Unruptured Membranes Prior to Cesarean Section
Description
Cochran-Mantel-Haenzel measure used to compare interaction in icNPT and Standard dressing stratified by Ruptured vs Unruptured membranes
Time Frame
Day of Surgery to 30 days postoperative
Title
Number of Patients in Labor Versus no Labor Prior to Cesarean Section
Description
Cochran-Mantel-Haenzel measure used to compare interaction in icNPT and Standard dressing stratified by patients in labor and patients not in labor
Time Frame
Day of Surgery to 30 days postoperative
Title
Number of Patients With Hypertension Versus no Hypertension
Description
Cochran-Mantel-Haenzel measure used to compare interaction between patients with hypertension versus no hypertension stratified by icNPT versus standard dressing, in wound morbidity
Time Frame
Day of Surgery to 30 days postoperative
Title
Number of Patients With Insulin Requiring Diabetes Versus no Insulin Requiring Diabetes
Description
Cochran-Mantel-Haenzel measure used to compare interaction in icNPT and Standard wound dressings stratified by women with insulin requiring diabetes and no insulin requiring Diabetes.
Time Frame
Day of Surgery to 30 days postoperative
Title
Number of Patients With Chorioamnionitis Versus no Chorioamnionitis
Description
Cochran-Mantel-Haenzel measure used to estimate interaction between chorioamnionitis and no chorioamnionitis stratified by icNPT and standard dressing, for wound morbidity
Time Frame
Day of Surgery to 30 days postoperative
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant women with BMI > 40 undergoing a cesarean delivery at Parkland Health and Hospital System.
Exclusion Criteria:
Any patient not meeting inclusion criteria will be deemed ineligible.
All HIV positive patients will be excluded due to the increased risk of infectious complications in these patients.
Although patients on anticoagulants can use NPWT, they will be excluded as there may be an increased risk of bleeding in these patients.
according to the wound therapy manufacturer's instructions patients with:
fragile skin
allergy to silver or acrylic adhesives
a malignancy in the wound bed or margins of the wound bed
non-enteric and unexplored fistulas
necrotic tissue with eschar present
exposed arteries, veins, nerves or organs, anastomotic sites, or surgical suction are not candidates for usage of the device.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Roberts, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkland Memorial Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31503147
Citation
Hussamy DJ, Wortman AC, McIntire DD, Leveno KJ, Casey BM, Roberts SW. Closed Incision Negative Pressure Therapy in Morbidly Obese Women Undergoing Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2019 Oct;134(4):781-789. doi: 10.1097/AOG.0000000000003465.
Results Reference
derived
Learn more about this trial
Negative Pressure Wound Therapy in Cesarean Section
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