NCT01700803

Brief Summary

The aim of this randomized clinical trial is to compare the efficiency of hand scrubbing by Povidone-Iodine solution 10% over 7.5% concentration in decreasing post-cesarean section wound infections \& compare side effects of both agents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,231

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_3

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2012

Completed
Last Updated

October 4, 2012

Status Verified

October 1, 2012

Enrollment Period

3 months

First QC Date

October 3, 2012

Last Update Submit

October 3, 2012

Conditions

Wound Infections

Keywords

BetadinePovidine IodineHand scrubbingCesarean section wound infectionspost cesarean section

Outcome Measures

Primary Outcomes (1)

  • The difference of incidence of surgical site infection between both groups

    Determine the difference in incidence of surgical site infection between Povidone Iodine 10% versus 7.5% hand scrub

    4 month

Secondary Outcomes (1)

  • The difference in the side effects between both groups e.g. dermatitis

    4 month

Study Arms (2)

Povidone Iodine 10%

EXPERIMENTAL

Using Povidone Iodine 10% hand scrub before caesarian section

Drug: Povidone Iodine 10% vand cesarean section wound infections

Povidone Iodine 7.5% hand scrub

EXPERIMENTAL

Using Povidone Iodine 7.5% hand scrub before caesarian section

Drug: Povidone Iodine 7.5% vand cesarean section wound infections

Interventions

Povidone Iodine 10% vand cesarean section wound infectionsDRUG
Povidone Iodine 10%
Povidone Iodine 7.5% vand cesarean section wound infectionsDRUG
Povidone Iodine 7.5% hand scrub

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • elective caesarian section (CS)

You may not qualify if:

  • diabetes,
  • immuno-compromised patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Wound Infection

Interventions

Povidone-Iodine

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

IodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 3, 2012

First Posted

October 4, 2012

Study Start

January 1, 2012

Primary Completion

April 1, 2012

Study Completion

May 1, 2012

Last Updated

October 4, 2012

Record last verified: 2012-10

Locations

EG(1)