Intervention for Postpartum Infections Following Caesarean Section
APIPICS
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 27, 2013
CompletedFirst Posted
Study publicly available on registry
July 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedOctober 18, 2016
October 1, 2016
3.5 years
June 27, 2013
October 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The frequency of re-rupture in each study group
Within the first 30 days after surgery
Secondary Outcomes (4)
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
Within the first 30 days after Caesarean Section
The cosmetic outcome as a measure of satisfaction
A 6 and 12 months follow-up
Study Arms (2)
Negative Pressure Wound Therapy
EXPERIMENTALNegative 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
A standard wound dressing
OTHERThe standard wound dressing is a hydrofiber or alginate dressing, used for open wound
Interventions
The Negative Pressure Wound Therapy are changed on the 2. day and removed on the 4. day after the re-operation.
The standard wound dressing is a a hydrofiber or alginate dressing used for open wounds
Eligibility Criteria
You may qualify if:
- Age ≥ 18 year
- Women, who can read and understand Danish
You may not qualify if:
- Serious illness requiring medical treatment, such as cancer
- Stillborn child
- If the fascia is ruptured
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Odense University Hospitallead
- Region of Southern Denmarkcollaborator
- University of Southern Denmarkcollaborator
- Hvidovre University Hospitalcollaborator
- Smith & Nephew, Inc.collaborator
Study Sites (1)
Odense University Hospital
Odense, 5000, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Student
Study Record Dates
First Submitted
June 27, 2013
First Posted
July 2, 2013
Study Start
May 1, 2011
Primary Completion
November 1, 2014
Study Completion
July 1, 2015
Last Updated
October 18, 2016
Record last verified: 2016-10