Intervention for Postpartum Infections Following Caesarean Section (APIPICS)
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|ClinicalTrials.gov Identifier: NCT01891006|
Recruitment Status : Completed
First Posted : July 2, 2013
Last Update Posted : October 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|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||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intervention for Postpartum Infections Following Caesarean Section - a Randomized Controlled Trial|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||July 2015|
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
- The frequency of re-rupture in each study group [ Time Frame: Within the first 30 days after surgery ]
- Length of hospitalization [ Time Frame: Within the first 30 days after Caesarean Section ]
- Readmission to hospital due to wound complications after the re-operation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01891006
|Odense University Hospital|
|Odense, Denmark, 5000|
|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|