Surgical Site Infection in Caesarean Section Using Alexis O Compared to Metal Retractors

Surgical Site Infection Clinical Trial

Official title: To Investigate the Incidence of Surgical Site Infection in Low Risk Women Having a First Time Planned Caesarean Section Using the Alexis O Retractor and the Traditional Metal Retractor

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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.

Statistics:

• Data analysis and statistical comparisons will be performed by the appropriate robust statistical methodology.

• Comparisons to be investigated

• Subjective Assessment of the Ease of Application of Retractor Instrument

• Incision to Delivery Time

• Incision to Skin Suture Time

• Subjective Assessment of Visualized Operative Field

• Subjective Assessment of Freedom of Surgical Movement

• Interference from Descending Bowel or Adnexal Tissue

• Bowel and Bladder Trauma

• Need for Bowel Packing

• Need for Paracolic Cleaning of Blood and Amniotic Fluid

• Need for Uterus Exteriorization Intraoperatively

• Fascial Trauma

• Muscle Trauma

• Muscle Suturing

• Coagulation of the Subcutaneous Tissue

• Subcutaneous Tissue Thickness

• Skin Lacerations

• Trauma to the Baby

• Estimated Blood Loss

• Ease of Retractor Removal

• Analgesia Requirements Post Operative

• Wound Healing Problems on Discharge and at 6 Weeks (Telephone Interview)

• Wound Infections (As defined by Centers for Disease Control)

• Time to Hospital Discharge

• 6-Week Scar Pain Scores (Telephone Interview)

• Patient Satisfaction with Wound Healing (Telephone Interview) ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection
• Surgical Site Infection
• Surgical Wound Infection

• NCT number: NCT02685696
• Study type: Interventional
• Source: Charite University, Berlin, Germany
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Completion date: February 2016