Intervention for Postpartum Infections Following Caesarean Section

Not Applicable

Completed

• Conditions: Surgical Wound Infection; Complications; Cesarean Section; Complications; Cesarean Section, Wound, Dehiscence; Cesarean Section; Dehiscence; Infection; Cesarean Section; Wound; Rupture, Surgery, Cesarean Section
• Interventions: Other: Standard wound dressing; Device: Negative Pressure Wound Therapy

• Registration Number: NCT01891006
• Lead Sponsor: Odense University Hospital

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2013-06-27
• Study First Submitted QC: 2013-07-01
• Study First Posted: 2013-07-02
• Primary Completion: 2014-11
• Study Completion: 2015-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-14
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

Inclusion Criteria

• Age ≥ 18 year
• Women, who can read and understand Danish

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Exclusion Criteria

• Serious illness requiring medical treatment, such as cancer
• Stillborn child
• If the fascia is ruptured

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A standard wound dressing	Standard wound dressing	The standard wound dressing is a hydrofiber or alginate dressing, used for open wound
Negative Pressure Wound Therapy	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

Primary Outcome Measures

Name	Time	Method
The frequency of re-rupture in each study group	Within the first 30 days after surgery

Secondary Outcome Measures

Name	Time	Method
Readmission to hospital due to wound complications after the re-operation	Within the first 30 days after Caesarean Section
Length of hospitalization	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	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	A 6 and 12 months follow-up	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.

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark