NCT02907892

Brief Summary

A randomized controlled trial to determine whether changing of gloves by the surgical team during cesarean section may decrease post-operative infectious morbidity and wound complications

Trial Health

87
On Track

Trial Health Score

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

Enrollment
554

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

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

July 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

August 17, 2018

Completed
Last Updated

August 17, 2018

Status Verified

December 1, 2017

Enrollment Period

1.3 years

First QC Date

September 16, 2016

Results QC Date

December 8, 2017

Last Update Submit

December 8, 2017

Conditions

Wound Complications

Outcome Measures

Primary Outcomes (1)

  • Composite Wound Complication

    Occurence of at least one of the following: wound seroma, wound hematoma, wound infection, skin separation of at least 1cm, or other incisional separation or abnormality requiring a bedside procedure to fix

    Within 8 weeks following cesarean section

Study Arms (2)

Control

NO INTERVENTION

Standard cesarean section surgical technique per surgeon preference

Glove Change

EXPERIMENTAL

Cesarean section including changing of sterile surgical gloves immediately prior to abdominal closure

Procedure: Glove change

Interventions

Glove changePROCEDURE

Intra-operative changing of sterile surgical gloves immediately prior to abdominal closure during cesarean section

Glove Change

Eligibility Criteria

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

You may qualify if:

  • Pregnant woman with singleton pregnancy and shared decision making with provider resulting in plan for cesarean section

You may not qualify if:

  • Severe immunocompromise (AIDS) or emergent nature of cesarean section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Results Point of Contact

Title
Dr. Rachel Vogel
Organization
University of Minnesota
isak0023@umn.edu
6513345982

Study Officials

  • Jonathan Scrafford, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2016

First Posted

September 20, 2016

Study Start

July 1, 2015

Primary Completion

November 1, 2016

Study Completion

January 1, 2017

Last Updated

August 17, 2018

Results First Posted

August 17, 2018

Record last verified: 2017-12

Locations

US(1)