Intervention for Postpartum Infections Following Caesarean Section (APIPICS)

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

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.

Study Overview

• Status: Completed
• Conditions: Surgical Wound Infection; Cesarean Section; Dehiscence; Complications; Cesarean Section; Infection; Cesarean Section; Complications; Cesarean Section, Wound, Dehiscence; Wound; Rupture, Surgery, Cesarean Section
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: RENASYS-G from Smith&Nephew
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The frequency of re-rupture in each study group	Within the first 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospitalization		Within the first 30 days after Caesarean Section
Readmission to hospital due to wound complications after the re-operation		Within the first 30 days after Caesarean Section
Number of participants with a decreased health-related quality of life score as a measure of satisfaction and tolerability	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.	Within the first 30 days after Caesarean Section
The cosmetic outcome as a measure of satisfaction	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.	A 6 and 12 months follow-up

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: Hvidovre University Hospital; Smith & Nephew, Inc.; University of Southern Denmark; Region of Southern Denmark

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: June 27, 2013
• First Submitted That Met QC Criteria: July 1, 2013
• First Posted (Estimate): July 2, 2013

Study Record Updates

• Last Update Posted (Estimate): October 18, 2016
• Last Update Submitted That Met QC Criteria: October 14, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Cesarean Section; Caesarean Section; Negative Pressure Wound Therapy; Economical Evaluation; Postoperative Wound Treatment; Surgical Site Infections; Wound Infections; Infectious Morbidity
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Infections; Communicable Diseases; Wounds and Injuries; Rupture; Surgical Wound; Surgical Wound Infection; Wound Infection
• Other Study ID Numbers: S-20120163