Antibiotics for Prevention of SSI in Obese Women Undergoi... | NCT03736187

Studies
Antibiotics for Prevention of SSI in Obese Women Undergoing CS

NCT03736187

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

Nov 9, 2018Actual

Enrollment

280Estimated

Phase

Not Applicable

Conditions

Surgical Site Infection

Interventions

Cephalexin

Countries

Not provided

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

Nov 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2019Estimated

Primary Completion Date

Oct 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Mar 27, 2018

First Submission Date that Met QC Criteria

Nov 7, 2018

First Posted Date

Nov 9, 2018Actual

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

Nov 7, 2018

Last Update Posted Date

Nov 9, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Abeer mohammed abd allah elsayed, Cairo governorate,hadaik elqoba,elkhalig elmasry street, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Effect of cephalexin plus metronidazole on SSI better than cephalexin alone in obese women undergoing CS

Detailed Description

Comparison between efficacy of cephalexin alone and cephalexin plus metronidazole on surgical site infection in obese women undergoing CS and follow up of any signs of wound infection

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

280Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cephalexin	Experimental	Group a will receive cephalexin 1gm before skin incision intravenous	Drug: Cephalexin
Cephalexin &metronidazole	Experimental	Group b will receive cephalexin 1gm intravenous plus 1gm metronidazole rectally before skin incision	Drug: Cephalexin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cephalexin	Drug	Giving cephalexin and metronidazole in one group &cephalexin alone in another group	Cephalexin Cephalexin &metronidazole

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Wound infection	Fever, redness, ecchymosis and tenderness	One week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

obese women under elective CS

Exclusion Criteria:

immunodeficient women

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013530	Surgical Wound Infection

Ancestor Terms

ID	Term
D014946	Wound Infection
D007239	Infections
D011183	Postoperative Complications
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002506	Cephalexin
D008795	Metronidazole

Ancestor Terms

ID	Term
D002511	Cephalosporins
D047090	beta-Lactams
D007769	Lactams
D000577	Amides
D009930

Browse Leaves

Not provided

Browse Branches

Not provided