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

Odense University Hospital

Status: Completed

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

Treatments: Other: Standard postoperative wound dressing; Device: iNPWT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01890720

S-20130010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 876 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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876 participants in 2 patient groups

iNPWT

Experimental group

Description:

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

Treatment:

Device: iNPWT

Standard wound dressing

Active Comparator group

Description:

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

Treatment:

Other: Standard postoperative wound dressing