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Completed

NCT Number: NCT01891006

Intervention for Postpartum Infections Following Caesarean Section

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Negative pressure wound therapy

Device

The Negative Pressure Wound Therapy are changed on the 2. day and removed on the 4. day after the re-operation.

Other names: RENASYS-G from Smith&Nephew

Standard wound dressing

Other

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

Primary outcomes

  1. The frequency of re-rupture in each study group

    Time frame: Within the first 30 days after surgery

Secondary outcomes

  1. Length of hospitalization

    Time frame: Within the first 30 days after Caesarean Section

  2. Readmission to hospital due to wound complications after the re-operation

    Time frame: Within the first 30 days after Caesarean Section

  3. Number of participants with a decreased health-related quality of life score as a measure of satisfaction and tolerability

    Time frame: Within the first 30 days after Caesarean Section

    A health-related quality of life measure, recorded in Quality Adjusted Life Years at the two interventions. The health-related quality of life score is measured on the 4 day after the re-operation and at the 6 and 12 months follow-up.

  4. The cosmetic outcome as a measure of satisfaction

    Time frame: A 6 and 12 months follow-up

    The scar will be evaluated by a plastic surgeon at a clinical examination 6 and 12 months after the re-operation. After study completion pictures of the scars will be evaluated by two blinded plastic surgeons, using two predefined scar scales.

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Hvidovre University Hospital
  • Region of Southern Denmark
  • Smith & Nephew, Inc.
  • University of Southern Denmark

Registry information

Official study title

Intervention for Postpartum Infections Following Caesarean Section - a Randomized Controlled Trial

Acronym: APIPICS

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Jul 2, 2013
Registry last updated
Oct 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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