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Intervention for Postpartum Infections Following Caesarean Section (APIPICS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Odense University Hospital
Sponsor:
Collaborators:
Region Southern Denmark
University of Southern Denmark
Hvidovre University Hospital
Smith & Nephew, Inc.
Information provided by (Responsible Party):
Nana Hyldig, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01891006
First received: June 27, 2013
Last updated: July 1, 2013
Last verified: June 2013
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intervention for Postpartum Infections Following Caesarean Section - a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • The frequency of re-rupture in each study group [ Time Frame: Within the first 30 days after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of hospitalization [ Time Frame: Within the first 30 days after Caesarean Section ] [ Designated as safety issue: No ]
  • Readmission to hospital due to wound complications after the re-operation [ Time Frame: Within the first 30 days after Caesarean Section ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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.

  • The cosmetic outcome as a measure of satisfaction [ Time Frame: A 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: May 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01891006

Contacts
Contact: Nana Hyldig, PhD Student 65415156 ext 0045 nana.hyldig@rsyd.dk
Contact: Jan Stener Joergensen, MD, PhD 65412346 ext 0045 jan.stener.joergensen@rsyd.dk

Locations
Denmark
Hvidovre Hospital Not yet recruiting
Hvidovre, Denmark, 2650
Contact: Tom Weber, MD    40136306 ext 0045    tom.weber@dadlnet.dk   
Principal Investigator: Tom Weber, MD         
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Nana Hyldig, PhD Student    65415156 ext 0045    nana.hyldig@rsyd.dk   
Principal Investigator: Nana Hyldig, PhD Student         
Sponsors and Collaborators
Odense University Hospital
Region Southern Denmark
University of Southern Denmark
Hvidovre University Hospital
Smith & Nephew, Inc.
Investigators
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:
No publications provided

Responsible Party: Nana Hyldig, PhD Student, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01891006     History of Changes
Other Study ID Numbers: S-20120163
Study First Received: June 27, 2013
Last Updated: July 1, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Comittee on Biomedical Research Ethics

Keywords provided by 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:
Surgical Wound Infection
Wound Infection
Rupture
Infection
Postoperative Complications
Pathologic Processes
Wounds and Injuries

ClinicalTrials.gov processed this record on August 25, 2014