Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-02-12 @ 11:16 PM
Study NCT ID:
NCT02289157
Status:
COMPLETED
Last Update Posted:
2018-07-02
First Post:
2014-10-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Negative Pressure Wound Therapy in Cesarean Section
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
Negative Pressure Wound Therapy in High Risk Patients Undergoing Cesarean
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NPWTCS
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: