Trial Outcomes & Findings for Do Single Use Negative Pressure Dressings Reduce Wound Complications in Obese Women After Cesarean Delivery (NCT NCT02799667)

Last Updated: 2021-02-21

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

110 participants

Primary outcome timeframe

2 weeks post partum/post operative period

Results posted on

2021-02-21

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	55	55
Overall Study COMPLETED	54	54
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Do Single Use Negative Pressure Dressings Reduce Wound Complications in Obese Women After Cesarean Delivery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Dressing n=55 Participants 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.	Negative Pressure Wound Therapy Dressing n=55 Participants 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.	Total n=110 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	55 Participants n=99 Participants	55 Participants n=107 Participants	110 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	31.2 years STANDARD_DEVIATION 5.3 • n=99 Participants	31.5 years STANDARD_DEVIATION 6.3 • n=107 Participants	31.3 years STANDARD_DEVIATION 5.8 • n=206 Participants
Sex: Female, Male Female	55 Participants n=99 Participants	55 Participants n=107 Participants	110 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=99 Participants	14 Participants n=107 Participants	22 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=99 Participants	41 Participants n=107 Participants	88 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	12 Participants n=99 Participants	10 Participants n=107 Participants	22 Participants n=206 Participants
Race (NIH/OMB) White	38 Participants n=99 Participants	41 Participants n=107 Participants	79 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=99 Participants	4 Participants n=107 Participants	8 Participants n=206 Participants
Region of Enrollment United States	55 Participants n=99 Participants	55 Participants n=107 Participants	110 Participants n=206 Participants
Body Mass Index	47.8 kg/m2 STANDARD_DEVIATION 6.9 • n=99 Participants	49.3 kg/m2 STANDARD_DEVIATION 6.6 • n=107 Participants	48.6 kg/m2 STANDARD_DEVIATION 6.8 • n=206 Participants
gestational age	36.4 weeks STANDARD_DEVIATION 3.3 • n=99 Participants	37.4 weeks STANDARD_DEVIATION 3.1 • n=107 Participants	36.9 weeks STANDARD_DEVIATION 3.2 • n=206 Participants
gestational diabetes	20 Participants n=99 Participants	15 Participants n=107 Participants	35 Participants n=206 Participants
pregestational diabetes	6 Participants n=99 Participants	9 Participants n=107 Participants	15 Participants n=206 Participants
current smoker	2 Participants n=99 Participants	4 Participants n=107 Participants	6 Participants n=206 Participants
former smoker	9 Participants n=99 Participants	6 Participants n=107 Participants	15 Participants n=206 Participants
chronic steroid use	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Insulin use	13 Participants n=99 Participants	15 Participants n=107 Participants	28 Participants n=206 Participants
Oral Hypoglycemic agent use	3 Participants n=99 Participants	2 Participants n=107 Participants	5 Participants n=206 Participants

PRIMARY outcome

Timeframe: 2 weeks post partum/post operative period

Outcome measures

Outcome measures
Measure	Standard Dressing n=55 Participants 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.	Negative Pressure Wound Therapy Dressing n=55 Participants 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.
Number of Participants With Composite Outcome of the Presence of Wound Complications Diagnosed by the Two Week Post Operative Appointment	14 Participants	10 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Standard Dressing n=55 Participants 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.	Negative Pressure Wound Therapy Dressing n=55 Participants 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.
Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment organ space SSI · no	55 Participants	55 Participants
Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment skin blisters · yes	5 Participants	1 Participants
Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment scar separation · yes	5 Participants	2 Participants
Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment seroma w/evacuation · no	54 Participants	53 Participants
Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment superficial SSI · yes	6 Participants	7 Participants
Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment superficial SSI · no	49 Participants	48 Participants
Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment deep SSI · yes	0 Participants	0 Participants
Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment deep SSI · no	55 Participants	55 Participants
Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment organ space SSI · yes	0 Participants	0 Participants
Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment skin blisters · no	50 Participants	54 Participants
Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment scar separation · no	50 Participants	53 Participants
Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment seroma w/evacuation · yes	1 Participants	2 Participants
Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment hematoma w/evacuation · yes	0 Participants	1 Participants
Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment hematoma w/evacuation · no	55 Participants	54 Participants
Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment wound debridement · yes	1 Participants	2 Participants
Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment wound debridement · no	54 Participants	53 Participants
Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment hospital readmission · yes	1 Participants	1 Participants
Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment hospital readmission · no	54 Participants	54 Participants
Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment additional operative room management · yes	0 Participants	1 Participants
Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment additional operative room management · no	55 Participants	54 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Standard Dressing n=55 Participants 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.	Negative Pressure Wound Therapy Dressing n=55 Participants 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.
Number of Participants With Composite Outcome of the Presence of Severe Wound Complications Diagnosed by the Two Week Post Operative Appointment	11 Participants	5 Participants

SECONDARY outcome

Timeframe: 6 weeks post partum/post operative period

Outcome measures

Outcome measures
Measure	Standard Dressing n=55 Participants 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.	Negative Pressure Wound Therapy Dressing n=55 Participants 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.
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	11 Participants

SECONDARY outcome

Timeframe: 6 weeks post partum/post operative period

Outcome measures

Outcome measures
Measure	Standard Dressing n=55 Participants 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.	Negative Pressure Wound Therapy Dressing n=55 Participants 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.
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	0 Participants
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	54 Participants
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	7 Participants
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	48 Participants
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	0 Participants
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	55 Participants
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	55 Participants
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	2 Participants
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	53 Participants
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	2 Participants
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	53 Participants
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	2 Participants
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	53 Participants
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	1 Participants
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	54 Participants
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	2 Participants
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	53 Participants
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	1 Participants
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	1 Participants
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	54 Participants

SECONDARY outcome

Timeframe: 6 weeks post partum/post operative period

Outcome measures

Outcome measures
Measure	Standard Dressing n=55 Participants 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.	Negative Pressure Wound Therapy Dressing n=55 Participants 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.
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	5 Participants

Adverse Events

Standard Dressing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Negative Pressure Wound Therapy Dressing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ashley T. Peterson, MD, Study Coordinator

Tufts Medical Center

Phone: 617-636-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place