Intervention for Postpartum Infections Following Caesarean Section

Surgical Wound Infection Clinical Trial

— APIPICS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01891006
• Other study ID #: S-20120163
• Status: Completed
• Phase: N/A
• First received: June 27, 2013
• Last updated: October 14, 2016
• Start date: May 2011
• Est. completion date: July 2015

Study information

• Verified date: October 2016
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cesarean Section; Dehiscence
• Communicable Diseases
• Complications; Cesarean Section
• Complications; Cesarean Section, Wound, Dehiscence
• Infection
• Infection; Cesarean Section
• Rupture
• Surgical Wound Infection
• Wound Infection
• Wound; Rupture, Surgery, Cesarean Section
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (5)

Lead Sponsor	Collaborator
Odense University Hospital	Hvidovre University Hospital, Region of Southern Denmark, Smith & Nephew, Inc., University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The frequency of re-rupture in each study group		Within the first 30 days after surgery	No
Secondary	Length of hospitalization		Within the first 30 days after Caesarean Section	No
Secondary	Readmission to hospital due to wound complications after the re-operation		Within the first 30 days after Caesarean Section	No
Secondary	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	No
Secondary	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	No

External Links

•   A website for use by the project participants