Prophylactic Incisional Care in Obese Women at Cesarean

NCT02578745 | Completed Results

• 1 other identifier: IRB ID # 201508154
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Surgical site infections (SSIs) complicate 5 - 12% of cesareans. Negative pressure wound therapy (NPWT) - a closed, sealed system that applies negative pressure to the wound surface - has been used to treat open wounds since the late 1990s. Experimental evidence suggests NPWT promotes wound healing by removing exudate, approximating the wound edges, and reducing bacterial contamination. Although effectiveness of prophylactic NPWT is biologically plausible and non-randomized studies suggest benefit in reducing SSIs, good quality data is lacking. The objective of this pilot randomized controlled trial of 120 patients to test the hypothesis that prophylactic NPWT will reduce SSIs and other wound complications after cesarean in obese women. The investigators will randomly assign obese women undergoing cesarean delivery to Standard dressing or prophylactic NPWT with the PICO system after skin closure. The primary outcome will be a composite of superficial or deep SSIs per Centers for Disease Control and Prevention (CDC) criteria and other wound complications (separation, hematoma, seroma) after cesarean. Secondary outcomes will include wound dehiscence (≥2 cm); hematoma; seroma; composite of wound complications; patient pain and satisfaction scores; physician office visit or emergency department (ED) visits for SSIs; and hospital readmission for wound complications.

Conditions

Wound Infections

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Composite Surgical Site Infection (SSI) or Other Wound Complication.

  Superficial or deep SSIs or other wound complications (separation, hematoma, seroma) after cesarean. SSI will be defined according to the Centers for Disease Control (CDC) criteria as infections at the surgical site occurring within 30 days of cesarean delivery, and classified as superficial, deep, or organ/space occupying.

  30 days

Secondary Outcomes (5)

• Number of Participants With Any COMPONENT of SSI or Composite Wound Complication

  30 days

• Pain Score on a 0 to 10 on Likert Scale

  Postoperative days 2

• Number of Participants With Positive Wound Culture

  30 days

• Number of Participants With Methicillin-resistant Staphylococcus Aureus.

  30 days

• Number of Participants With Any Prophylactic Negative Pressure-related Adverse Events.

  30 days

Study Arms (2)

Prophylactic NPWT

EXPERIMENTAL

Women assigned to prophylactic NPWT will have the PICO device applied and secured with fixation adhesion strips. The device will be monitored while the patient is in the hospital to confirm that it is functioning well. The device will be removed prior to discharge, typically on postoperative day 4.

Device: Prophylactic NPWT (PICO system)

Standard Dressing

ACTIVE COMPARATOR

Women assigned to standard care will receive routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing will be removed after 24 - 48 hours.

Other: Standard Dressing

Interventions

Prophylactic NPWT (PICO system) DEVICE

The PICO NPWT system is a small, lightweight (\~126 grams), portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary super-absorbent adhesive dressing. It is supplied as a pump with two sterile dressing kits and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 10 to 40 cm. The PICO pump maintains negative pressure of -80 mmHg (+/-20 mmHg) to the wound surface.

Prophylactic NPWT

Standard Dressing OTHER

Standard wound dressing consists of routine postoperative wound dressing consisting of layers of gauze and adhesive tape.

Standard Dressing

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Gestational age ≥23weeks
• BMI≥30 at the time of delivery
• Planned or unplanned cesarean delivery (procedure in which NPWT is being tested)

You may not qualify if:

• Non-availability for postoperative follow-up (follow-up is needed to ascertain study outcomes)
• Contraindication to NPWT applicable to women undergoing cesarean (device will not be used in patients with contraindications): Pre-existing infection around incision site, Bleeding disorder, Therapeutic anticoagulation, Allergy to any component of the dressing (e.g. silicone, adhesive tape)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Barnes-Jewish Hospital

St Louis, Missouri, 63108, United States

Location

Related Publications (5)

• Bullough L, Spruce P. Removing all barriers: a 10-patient evaluation in the acute care setting. Br J Nurs. 2013 Nov 14-27;22(20):S38, S40-4. doi: 10.12968/bjon.2013.22.Sup20.S38.

  PMID: 24225510 BACKGROUND

• Mark KS, Alger L, Terplan M. Incisional negative pressure therapy to prevent wound complications following cesarean section in morbidly obese women: a pilot study. Surg Innov. 2014 Aug;21(4):345-9. doi: 10.1177/1553350613503736. Epub 2013 Sep 20.

  PMID: 24056202 BACKGROUND

• Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988.

  PMID: 20054046 BACKGROUND

• Swift SH, Zimmerman MB, Hardy-Fairbanks AJ. Effect of Single-Use Negative Pressure Wound Therapy on Postcesarean Infections and Wound Complications for High-Risk Patients. J Reprod Med. 2015 May-Jun;60(5-6):211-8.

  PMID: 26126306 BACKGROUND

• Bullough, L, Wilkinson, D., Burns, S, Wan, L, Changing wound care protocols to reduce postoperative caesarean section infection and readmission, Wounds , 2014 (10), 1 : 72 - 76. 46

  BACKGROUND

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Results Point of Contact

• Title: Methodius Tuuli
• Organization: Washington University

methodiustuuli@yahoo.com

6785582874

Study Officials

• Methodius G Tuuli, MD, MPH

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2015
• First Posted: October 19, 2015
• Study Start: October 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: November 27, 2019
• Results First Posted: October 22, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)