NCT02685696

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 19, 2016

Completed
Last Updated

February 19, 2016

Status Verified

February 1, 2016

Enrollment Period

2.3 years

First QC Date

February 8, 2016

Last Update Submit

February 14, 2016

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (24)

  • Application Satisfaction Scale Scores

    Immediate Postoperative

  • Removal Satisfaction Scale Scores

    On the day of Surgery (Day 0)

  • Post Operative Pain Scale Scores at Discharge

    On the day of discharge (3-5 days)

  • Post Operative Pain at 6 Weeks

    6 weeks post operative

  • Patients with Wound Dehisence at Discharge

    On the day of discharge (3-5 days)

  • +19 more secondary outcomes

Study Arms (2)

Alexis O Retractor

EXPERIMENTAL

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

Device: Alexis O Retractor

Metal Retractor

ACTIVE COMPARATOR

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

Device: Metal Retractor

Interventions

Alexis O RetractorDEVICE

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.

Alexis O Retractor
Metal RetractorDEVICE

The traditional self-retaining metal Collins Caesarean Wound Retractor.

Also known as: Collins
Metal Retractor

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women
  • Elective Caesarean Section
  • First Caesarean Section

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 23490472BACKGROUND

  • 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.

    PMID: 20849290BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Larry Hinkson, MBBS,MRCOG

    Charité University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant in Obstetrics

Study Record Dates

First Submitted

February 8, 2016

First Posted

February 19, 2016

Study Start

October 1, 2013

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

February 19, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share