Intervention for Postpartum Infections Following Caesarean Section (APIPICS)

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: Device: Negative Pressure Wound Therapy; Other: Standard wound dressing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01891006

S-20120163

Details and patient eligibility

About

The purpose of this study is to examine whether Negative Pressure Wound Therapy is an effective wound treatment compared to conventional wound treatment in the period of time from reoperation to re-suturing in women having surgical wound rupture after Caesarean Section.

Full description

This study is a non-blinded randomized controlled trial and a concurrent Health Economic. The study examines the effect on wound healing using NPWT compared with conventional wound treatment in women, who experience spontaneous dehiscence or where a surgeon deliberately opens the wound after Caesarean Section (CS).

Women, who have given informed consent, will be randomized to either intervention or control group via a computer-generated randomization program. It is not possible to blind either participants or therapists. The analysis will be carried out on an intention to treat basis.

Women with post-CS wound infection will be hospitalized and the wound will be reopened and cleaned under general anaesthesia. In the intervention group women will be treated with NPWT. The change of wound dressing on the second day takes place in the obstetrical or plastic surgery ward. On the fourth day, the NPWT material will be removed and the wound evaluated before re-suturing. In the control group the wound will be treated with a hydrofiber or alginate dressing. Changes of wound dressing will take place on the second and fourth days as in the intervention group. In both groups, when the wound is evaluated on the second and fourth day, it will be described and measured (depth, width, length). After four days of treatment, the wound will be re-sutured in both groups. It is expected that some wounds are not suitable for re-suturing on the fourth day. If a woman does not want to participate, she will receive the conventional treatment, which corresponds to the treatment in the control group. Women, who do not wish to participate, will be asked for permission to use their data in the analysis.

Enrollment: 26 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 year
• Women, who can read and understand Danish

Exclusion criteria

• Serious illness requiring medical treatment, such as cancer
• Stillborn child
• If the fascia is ruptured

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Negative Pressure Wound Therapy

Experimental group

Description:

Negative Pressure Wound Therapy (NPWT) is an alternative method of conservative wound management, which uses negative pressure to promote wound healing in both chronic and acute wounds. The rationale for using NPWT is that it mechanically stimulates the formation of new tissue and removes wound fluid and infectious material

Treatment:

Device: Negative Pressure Wound Therapy

A standard wound dressing

Other group

Description:

The standard wound dressing is a hydrofiber or alginate dressing, used for open wound

Treatment:

Other: Standard wound dressing