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

NCT ID: NCT02685696

Last Updated: 2016-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-02-29

Brief 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.

Detailed 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)

Conditions

Surgical Site Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Alexis O Retractor

Group 1 received the Alexis-O-Retractor at thet time of first Caesarean Section

Group Type: EXPERIMENTAL

Alexis O Retractor

Intervention Type: DEVICE

A newly developed abdominal wall retractor for Caesarean Section is the Alexis O Ring which is formed of 2 rings and a interconnecting plastic polyurethane sheath where the flexible inner ring is placed into the abdomen and where the rigid outer ring is rolled to create tension on the plastic sheath providing 360° abdominal wound retraction with simultaneously a tamponade effect whilst covering the abdominal wound during the Caesarean Section and delivery of the baby.

Metal Retractor

Group 2 received the traditional self retaining metal Retractor at thet time of first Caesarean Section

Group Type: ACTIVE_COMPARATOR

Metal Retractor

Intervention Type: DEVICE

The traditional self-retaining metal Collins Caesarean Wound Retractor.

Interventions

Alexis O Retractor

A newly developed abdominal wall retractor for Caesarean Section is the Alexis O Ring which is formed of 2 rings and a interconnecting plastic polyurethane sheath where the flexible inner ring is placed into the abdomen and where the rigid outer ring is rolled to create tension on the plastic sheath providing 360° abdominal wound retraction with simultaneously a tamponade effect whilst covering the abdominal wound during the Caesarean Section and delivery of the baby.

Intervention Type: DEVICE

Metal Retractor

The traditional self-retaining metal Collins Caesarean Wound Retractor.

Intervention Type: DEVICE

Other Intervention Names

Collins

Eligibility Criteria

Inclusion Criteria

• Women
• Elective Caesarean Section
• First Caesarean Section

Exclusion Criteria

• Diabetes
• Chronic auto immune diseases
• Lupus
• Immune deficiency diseases
• HIV
• known bleeding disorders
• full anti-coagulation therapy
• wound healing problems
• previous Caesarean Section
• major abdominal surgery
• laparotomy
• active phase of labor
• suspected chorioamnionitis
• confirmed chorioamnionitis

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Larry Hinkson

Consultant in Obstetrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Larry Hinkson, MBBS,MRCOG

Role: PRINCIPAL_INVESTIGATOR

Charité University Hospital

References

Klingel ML, Patel SV. A meta-analysis of the effect of inspired oxygen concentration on the incidence of surgical site infection following cesarean section. Int J Obstet Anesth. 2013 Apr;22(2):104-12. doi: 10.1016/j.ijoa.2013.01.001. Epub 2013 Mar 13.

Reference Type: BACKGROUND

PMID: 23490472 (View on PubMed)

Horiuchi T, Tanishima H, Tamagawa K, Sakaguchi S, Shono Y, Tsubakihara H, Tabuse K, Kinoshita Y. A wound protector shields incision sites from bacterial invasion. Surg Infect (Larchmt). 2010 Dec;11(6):501-3. doi: 10.1089/sur.2009.072. Epub 2010 Sep 17.

Reference Type: BACKGROUND

PMID: 20849290 (View on PubMed)

Other Identifiers

AlexisO1

Identifier Type: -

Identifier Source: org_study_id