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Intervention for Postpartum Infections Following Caesarean Section (APIPICS)

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ClinicalTrials.gov Identifier: NCT01891006
Recruitment Status : Completed
First Posted : July 2, 2013
Last Update Posted : October 18, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Surgical Wound Infection Infection; Cesarean Section Cesarean Section; Dehiscence Complications; Cesarean Section Complications; Cesarean Section, Wound, Dehiscence Wound; Rupture, Surgery, Cesarean Section Device: Negative Pressure Wound Therapy Other: Standard wound dressing

Detailed 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intervention for Postpartum Infections Following Caesarean Section - a Randomized Controlled Trial
Study Start Date : May 2011
Primary Completion Date : November 2014
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Negative Pressure Wound Therapy
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
Device: Negative Pressure Wound Therapy
The Negative Pressure Wound Therapy are changed on the 2. day and removed on the 4. day after the re-operation.
Other Name: RENASYS-G from Smith&Nephew
A standard wound dressing
The standard wound dressing is a hydrofiber or alginate dressing, used for open wound
Other: Standard wound dressing
The standard wound dressing is a a hydrofiber or alginate dressing used for open wounds

Outcome Measures

Primary Outcome Measures :
  1. The frequency of re-rupture in each study group [ Time Frame: Within the first 30 days after surgery ]

Secondary Outcome Measures :
  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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01891006

Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Region of Southern Denmark
University of Southern Denmark
Hvidovre University Hospital
Smith & Nephew, Inc.
Study Chair: 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
More Information

Additional Information:
Responsible Party: Nana Hyldig, PhD Student, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01891006     History of Changes
Other Study ID Numbers: S-20120163
First Posted: July 2, 2013    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016

Keywords provided by Nana Hyldig, Odense University Hospital:
Randomized Controlled Trial
Economical Evaluation
Caesarean Section
Cesarean Section
Postoperative Wound Treatment
Surgical Site Infections
Wound Infections
Infectious Morbidity
Negative Pressure Wound Therapy

Additional relevant MeSH terms:
Communicable Diseases
Wounds and Injuries
Wound Infection
Surgical Wound
Surgical Wound Infection
Postoperative Complications
Pathologic Processes