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

NCT01890720 | Completed

• 1 other identifier: S-20130010
• Study Type: interventional
• Target: 876
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Randomized Controlled Trial; Economical Evaluation; Caesarean Section; postoperative wound treatment; surgical site infections; wound infections; infectious morbidity; Negative Pressure Wound Therapy; Incisional Negative Pressure Wound Therapy; Obesity

Outcome Measures

Primary Outcomes (1)

• The incidence of post-CS wound infection in each study group

  Wound infection requiring antibiotic treatment To be able to collect information about symptoms of infection after discharge a self-administered questionnaire will be sent to all participants within 30 days post-CS. Furthermore data on postoperative infections, recorded by diagnoses codes or surgical procedures, will be obtained from the Danish National Patient Registry

  Within the first 30 days after surgery

Secondary Outcomes (6)

• Length of the primary and any secondary hospitalization

  Within the first 30 days after Caesarean Section

• Readmissions to hospital/contact to the general practitioner on suspicion of infection following caesarean section

  Within the first 30 days after Caesarean Section

• Number of Participants with a decreased health-related quality of life score as a measure of satisfaction and tolerability

  Within the first 30 days after Caesarean Section

• Antibiotic treatment on suspicion of infection after Caesarean Section

  Within the first 30 days after Caesarean Section

• The cosmetic outcome as a measure of satisfaction

  A 6 and 12 months follow-up

Study Arms (2)

iNPWT

EXPERIMENTAL

Negative Pressure Wound Therapy (NPWT) is a mechanical wound care treatment using controlled sub-atmospheric pressure to assist and accelerate wound healing. Incisional Negative Pressure Wound Therapy (iNPWT) is a new NPWT devices, which can be used over clean closed surgical incisions. The device behaves in a similar fashion to existing conventional NPWT devices, i.e. transmission of negative pressure levels at the wound bed, tissue contraction and establishing a characteristic pattern of peri-wound blood flow and that it reduces and normalises tissue stresses at the incision

Device: iNPWT

Standard wound dressing

ACTIVE COMPARATOR

The standard postoperative wound dressing is a normal wound dressing, used over clean closed incisions.

Other: Standard postoperative wound dressing

Interventions

iNPWT DEVICE

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.

Also known as: incisional Negative Pressure Wound Therapy

iNPWT

Standard postoperative wound dressing OTHER

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.

Standard wound dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 year
• Women who can read and understand Danish
• pregestational BMI ≥ 30 kg/m2

Sponsors & Collaborators

• Odense University Hospital: lead
• Region of Southern Denmark: collaborator
• University of Southern Denmark: collaborator
• Hvidovre University Hospital: collaborator
• Smith & Nephew, Inc.: collaborator

Study Sites (5)

Aarhus University Hospital

Aarhus, Jutland, 8200, Denmark

Location

Hospital South West Jutland

Esbjerg, Jutland, 6700, Denmark

Location

Hospital Lillebaelt, Kolding Hospital

Kolding, Jutland, 6000, Denmark

Location

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Surgical Wound Infection; Infections; Wounds and Injuries; Rupture; Wound Infection; Obesity

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Officials

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 2, 2013
• Study Start: September 10, 2013
• Primary Completion: October 13, 2016
• Study Completion: December 1, 2016
• Last Updated: January 31, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (5)