Clinical trial NCT01891006: Intervention for Postpartum Infections Following Caesarean Section
Official title: Intervention for Postpartum Infections Following Caesarean Section - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound Infection
Infection; Cesarean Section
Cesarean Section; Dehiscence
Complications; Cesarean Section
Complications; Cesarean Section, Wound, Dehiscence
Wound; Rupture, Surgery, Cesarean Section
Keywords: Randomized Controlled Trial
Economical Evaluation
Caesarean Section
Cesarean Section
Postoperative Wound Treatment
Surgical Site Infections
Wound Infections
Infectious Morbidity
Negative Pressure Wound Therapy
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Region of Southern Denmark
name: University of Southern Denmark
name: Hvidovre University Hospital
name: Smith & Nephew, Inc.
First posted: 2013-07-02
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: The frequency of re-rupture in each study group
timeFrame: Within the first 30 days after surgery
Secondary outcomes:
measure: Length of hospitalization
timeFrame: Within the first 30 days after Caesarean Section
measure: Readmission to hospital due to wound complications after the re-operation
timeFrame: Within the first 30 days after Caesarean Section
measure: Number of participants with a decreased health-related quality of life score as a measure of satisfaction and tolerability
timeFrame: Within the first 30 days after Caesarean Section
measure: The cosmetic outcome as a measure of satisfaction
timeFrame: A 6 and 12 months follow-up
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: 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
name: Nana Hyldig, PhD Student
role: STUDY_CHAIR
References: