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Objective:
To investigate if the use of the newly designed Alexis O Retractor leads to improved intra-operative and post-operative surgical outcomes in the setting of planned elective Caesarean Sections.
Study Design:
This ethically approved study is designed as a prospective, randomized controlled trial in planned, first time Caesarean Sections with 200 patients randomized to either the Alexis-O Retractor group or the conventional group. Patients with wound healing problems, connective tissue disorders, insulin dependent diabetes, bleeding disorders, previous major abdominal surgery and chorioamnionitis are excluded. Outcomes include surgical site infection, intraoperative parameters such as tissue damage, postoperative analgesia requirements and patient satisfaction scores.
Full description
Main Hypothesis:
Does the use of the newly designed Alexis O Retractor lead to improved Surgical Site Infection rates intra-operative and post-operative surgical outcomes in the setting of planned elective first time Caesarean Sections in patients compared to the traditional self-retaining metal retractor?
Secondary Hypotheses:
Does the Alexis O Retractor lead to improved intra-operative and post-operative surgical outcomes in the setting of planned elective Caesarean Sections?
Study Design:
The Study is designed as a prospective, randomized controlled trial with 100 patients randomized to the Alexis O Retractor group and 100 patients to the conventional group.
All patients will be recruited following a thorough discussion about the purpose and methodology of the study and full documented consent will be obtained prior to randomization.
Patients with wound healing problems, connective tissue disorders, diabetes, bleeding disorders, previous abdominal surgery apart from laparoscopy and chorioamnionitis will be excluded.
All surgical operators are thoroughly trained in the use and application of the Alexis O Retractor prior to the start of the study and supported by regular teaching demonstrations. The Obstetric Theatre Team is informed and trained in use and application of the Alexis O Retractor within the Study Design.
Ethical Approval:
Ethical Approval has already been obtained from the Ethics committee at the Charité University Hospital Committee and in keeping with ethical standards.
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200 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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