Incisional Negative Pressure Wound Therapy for Prevention of Postoperative Infections Following Caesarean Section

Summary

The purpose of this study is to examine whether obese women (BMI \>= 30) who give birth by caesarean section have a reduced incidence of wound infection and dehiscence when incisional Negative Pressure Wound Therapy is applied prophylactically following caesarean section.

Conditions

• Surgical Wound Infection
• Infection; Cesarean Section
• Cesarean Section; Dehiscence
• Complications; Cesarean Section
• Complications; Cesarean Section, Wound, Dehiscence
• Wound; Rupture, Surgery, Cesarean Section

Interventions

DEVICE

iNPWT

The Incisional Negative Pressure Wound Therapy (iNPWT) will be applied over the clean closed incision immediately following the operation (caesarean section). In the intervention group the therapy will be left in situ for five days.

OTHER

Standard postoperative wound dressing

A standard wound dressing will be applied over the clean closed incision immediately following the operation (caesarean section). In the control group the dressing will be left in situ for at least 24 hours as standard procedure.

Sponsors & Collaborators

• Region of Southern Denmark

  collaborator OTHER

• University of Southern Denmark

  collaborator OTHER

• Hvidovre University Hospital

  collaborator OTHER

• Smith & Nephew, Inc.

  collaborator INDUSTRY

• Odense University Hospital

  lead OTHER

Principal Investigators

• Nana Hyldig, PhD Student · Odense University Hospital, department of Plastic Surgery, University of Southern Denmark, Faculty of Health Sciences, institute of Clinical Research, research unit, department of Gynaecology and Obstetrics

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-09-10

Primary Completion

2016-10-13

Completion

2016-12-31

Countries

• Denmark

Study Locations