Early Bandage Removal Post-Cesarean Delivery | NCT01867567

Studies
Early Bandage Removal Post-Cesarean Delivery

NCT01867567

Sponsor

Ziv Hospital

Status

Completed

Last Update Posted

Dec 30, 2015Estimated

Enrollment

320Actual

Phase

Not Applicable

Conditions

Wound Disruption
Wound Infection

Interventions

abdominal bandage

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

May 26, 2013

First Submission Date that Met QC Criteria

Jun 3, 2013

First Posted Date

Jun 4, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2015

Last Update Posted Date

Dec 30, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Women undergoing their first second or third cesarean section will be randomized into two groups. One group will have the abdominal bandage removed at 6 hours post-surgery and the other group will have the bandage removed at 24 hours. Staple removal will be at 5 - 7 days for both groups. The incision will be inspected at the time of staple removal. The 2 groups will be compared for incision disruption and infection. Also, the women will be asked about their satisfaction for time of bandage removal.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

320Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
6 Hours	Experimental	Removal of bandage after 6 hours	Procedure: abdominal bandage
24 hours	Active Comparator	removal of bandage after 24 hours	Procedure: abdominal bandage

Interventions

Name	Type	Description	Arm Group Labels	Other Names
abdominal bandage	Procedure		24 hours 6 Hours

Measure	Description	Time Frame
Wound Disruption		5 - 7 days

Measure	Description	Time Frame
Wound Infection		5 - 7 days
Patient satisfaction		5 - 7 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age of 18 to 44
elective cesarean section, primary or repeat
low risk pregnancy

Exclusion Criteria:

under the age of 18 and above the age of 44
diabetes, preeclampsia or other pregnancy complications
unable or unwilling to give informed consent
chorioamnionitis
BMI over 35
more than 3 cesareans

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ziv Medical center		Safed		13100	Israel

Condition Browse Module

MeSH Terms

ID	Term
D014946	Wound Infection
D007239	Infections
D010549	Personal Satisfaction
D017060	Patient Satisfaction

Ancestor Terms

ID	Term
D001519	Behavior
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior

Browse Leaves

Not provided

Browse Branches

Not provided