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

NCT ID: NCT01890720

Last Updated: 2017-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 876 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-10
• Study Completion Date: 2016-12-31

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.

Detailed Description

This study is a non-blinded randomised controlled trial and a concurrent Health Economic Evaluation. The study examines the effect on wound healing using incisional Negative Pressure Wound Therapy (iNPWT) compared with standard postoperative dressings in women with a BMI >= 30, who has a Caesarean Section (CS). We expect to find a lower frequency of wound complications when using iNPWT directly on primary suturing compared to standard postoperative dressings in this high-risk subpopulation.

Women, who have given informed consent, will be randomised to either intervention or control group via a computer-generated randomisation program. Elective and emergency CS will be stratified to ensure roughly equal numbers in each category of CS in each arm of the study and permit valid separate and pooled analysis. The analysis will be carried out on an intention to treat basis.

The iNPWT or standard postoperative dressings will be applied in theatre immediately following the operation. In the intervention group the therapy will be left in situ for five days corresponding to the date of removal of stitches. In the control group the dressing will be left in situ for at least 24 hours as standard procedure. Women, who do not wish to participate, will be asked for permission to use their data in the analysis.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

iNPWT

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

Group Type: EXPERIMENTAL

iNPWT

Intervention Type: 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.

Standard wound dressing

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

Group Type: ACTIVE_COMPARATOR

Standard postoperative wound dressing

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

incisional Negative Pressure Wound Therapy

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Region of Southern Denmark

OTHER

Sponsor Role: collaborator

University of Southern Denmark

OTHER

Sponsor Role: collaborator

Hvidovre University Hospital

OTHER

Sponsor Role: collaborator

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nana Hyldig

PhD Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nana Hyldig, PhD Student

Role: STUDY_CHAIR

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

Locations

Aarhus University Hospital

Aarhus, Jutland, Denmark

Hospital South West Jutland

Esbjerg, Jutland, Denmark

Hospital Lillebaelt, Kolding Hospital

Kolding, Jutland, Denmark

Hvidovre Hospital

Hvidovre, , Denmark

Odense University Hospital

Odense, , Denmark

Countries

Denmark

Other Identifiers

S-20130010

Identifier Type: -

Identifier Source: org_study_id