Short summary

Objective:
To assess the effectiveness of incisional Negative Pressure Wound Therapy on closed surgical incisions

Design:
An unblinded parallel randomised controlled multicentre trial and a concurrent Health Economic Evaluation.

Setting:
Obstetrics departments at Odense, Aarhus, Kolding, Esbjerg and Hvidovre Hospital, Denmark.

Population:
Women (BMI>30) giving birth by caesarean section.

Methods:
Women are randomly assigned into two groups. The Negative Pressure Wound Therapy dressing or standard postoperative dressings will be applied in theatre immediately following the operation.

Main outcome:
Measure Incidences of post-caesarean wound complications in each study group.

Rationale

Women undergoing caesarean section (CS) have an increased risk of postpartum infections compared to women undergoing vaginal delivery. The most common post-CS infections are endometritis, urinary tract infections and wound infections.

Negative Pressure Wound Therapy (NPWT) is a mechanical wound care treatment using controlled sub-atmospheric pressure to assist and accelerate wound healing. The rationale for using NPWT is that it mechanically stimulates the formation of new tissue, alters blood flow at the wound edges, and removes wound fluid and infectious material. NPWT has been used worldwide in wound management in both chronic and acute wounds over the past 15-20 years. Since 2010 two simplified NPWT dressings has been available. An advantage of these simplified NPWT dressings is that they can be applied prophylactically on primary closed surgical incision in order to prevent surgical wound complications such as wound infection, wound dehiscence and seroma. As wound complications have an impact on hospital costs and the patient's quality of life it is important to investigate the effectiveness and cost of the prophylactic use of incisional NPWT, on closed surgical incisions, in a population of women at high-risk of post-CS wound complications.

Description of the cohort

Women with a BMI > 30 giving birth by caesarean section.

Data and biological material

Wounds will be evaluated at day 5 following caesarean section.

Information about symptoms of infection after discharge and HRQoL will be obtained by a questionnaire sent electronically to all participants. The questionnaire data will subsequently be compared with hospital diagnostic codes and any prescriptions of antibiotics.

A sub-group will have their scar evaluated by a plastic surgeon at a clinical examination 6 and 12 months after their caesarean section.

Collaborating researchers and departments

Department of Plastic Surgery and Department of Gynaecology and Obstetrics, Odense University Hospital

• PhD-student Nana Hyldig, MHSc

Department of Business and Economics, University of Southern Denmark

• Senior Advisor Marie Kruse, MSc, PhD

Department of Plastic Surgery, Odense University Hospital

• Associate Professor Camilla Bille, MD, PhD
• Professor Jens Ahm Sørensen, MD, PhD

Department of Gynaecology and Obstetrics, Odense University Hospital

• Christina Vinter, MD, PhD
• Professor Ole Mogensen, MD
• Professor Jan Stener Jørgensen, MD, PhD