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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02685696
• Other study ID #: AlexisO1
• Status: Completed
• Phase: N/A
• First received: February 8, 2016
• Last updated: February 14, 2016
• Start date: October 2013
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

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

Intervention

Device:
• 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.
• Metal Retractor
The traditional self-retaining metal Collins Caesarean Wound Retractor.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

References & Publications (2)

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of surgical site infection in low risk women having a first time planned Caesarean Section using the Alexis O Retractor compared to the traditional Metal Retractor.		6-8 Weeks after Surgery	Yes
Secondary	Application Satisfaction Scale Scores		Immediate Postoperative	Yes
Secondary	Removal Satisfaction Scale Scores		On the day of Surgery (Day 0)	Yes
Secondary	Post Operative Pain Scale Scores at Discharge		On the day of discharge (3-5 days)	No
Secondary	Post Operative Pain at 6 Weeks		6 weeks post operative	No
Secondary	Patients with Wound Dehisence at Discharge		On the day of discharge (3-5 days)	Yes
Secondary	Patients with either open wounds, infected wounds, bleeding wounds or painful wound at 6 Weeks		6 weeks post operative	Yes
Secondary	Blood Loss Volume		On the day of Surgery (Day 0)	No
Secondary	Visual Field Satisfaction Scores		On the day of Surgery (Day 0)	No
Secondary	Freedom of Movement Satisfaction Scores		On the day of Surgery (Day 0)	No
Secondary	No. Patients with Prolapsing Bowel in the operative field at the time of Caesarean Section		On the day of Surgery (Day 0)	No
Secondary	No. of Patients needing repositioning of prolapsing bowel at the time of Caesarean		On the day of Surgery (Day 0)	No
Secondary	No. of Patients with bowel injury sustained at the time of Caesarean Section		On the day of Surgery (Day 0)	Yes
Secondary	No. of Patients sustaining bladder injury at the time of Caesarean Section		On the day of Surgery (Day 0)	Yes
Secondary	No. of Patients where bowel packing with abdominal swabs was performed at the time of Caesarean Section		On the day of Surgery (Day 0)	No
Secondary	No. of Patients where suction of Blood and Liquor from the parabolic gutters was necessary at the time of Caesarean Section		On the day of Surgery (Day 0)	No
Secondary	No. of Patients where the Uterus was exteriorized at the time of Caesarean Section		On the day of Surgery (Day 0)	No
Secondary	No. of Patients with Rectus Sheath Fascial Tears at the time of Caesarean Section		On the day of Surgery (Day 0)	Yes
Secondary	No. of Patients with Rectus Muscle Tearing at the time of Caesarean Section		On the day of Surgery (Day 0)	Yes
Secondary	No. of Patients where Rectus Muscle Suturing was performed at the time of Caesarean		On the day of Surgery (Day 0)	No
Secondary	No. of Patients where Subcutaneous Electro-Coagulation was performed at the time of Caesarean Section		On the day of Surgery (Day 0)	No
Secondary	No. of Patients with lacerations to the skin wound edges at the time of Caesarean Section		On the day of Surgery (Day 0)	Yes
Secondary	No. of Patients where the Baby was cut at the time of Caesarean Section		On the day of Surgery (Day 0)	Yes
Secondary	Wound Healing Satisfaction at 6 Weeks		6 weeks post operative.	No
Secondary	Time to Discharge		3-5 Days	Yes