NCT01891006

Intervention for Postpartum Infections Following Caesarean Section

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgical Wound Infection
• Infection; Cesarean Section
• Cesarean Section; Dehiscence
• Complications; Cesarean Section
• Complications; Cesarean Section, Wound, Dehiscence
• Wound; Rupture, Surgery, Cesarean Section

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-11-01
• Completion: 2015-07-01
• First posted: 2013-07-02
• Last updated: 2016-10-18

Locations

1 site across 1 country: Denmark