NCT01619137

Brief Summary

Comparison of the effect of water and soap irrigation with Povidone-iodine And normal salin treatment of patients with ununion laparatomy or episiotomy wound ( a pilot study)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2012

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 14, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

October 10, 2012

Status Verified

October 1, 2012

Enrollment Period

1.2 years

First QC Date

January 19, 2012

Last Update Submit

October 5, 2012

Conditions

Wound

Keywords

ununion woundsoapirrigationPovidone-iodinenormal salin

Outcome Measures

Primary Outcomes (1)

  • number of admission day

    number of days the patients in each group admitted in hospital

    1 month

Secondary Outcomes (1)

  • complication of each treatment

    1 months

Study Arms (2)

Povidone-iodine And normal salin

ACTIVE COMPARATOR

40 patients with complaint of ununion wound of laparatomy or episiotomy coming to Gynecologist's office or hospital enrolled to this study randomly recieve Povidone-iodine And normal salin treatment.

Drug: Povidone-iodine And normal salin treatment

water and soap

ACTIVE COMPARATOR

40 patients coming to Gynecologist's offices or hospital with complaint of ununion wound of laparatomy or episiotomy in Bandarabbas enrolled to this study and randomly recieve water and soap to irrigation of the wound (it's not require to be at hospital), washing is for each 6-8 hours per day. and if not difference seen after 4 day, treatment change to Povidone-iodine And normal salin.

Drug: water and soap

Interventions

water and soapDRUG

water and soap for 6-8 hours per day.

water and soap
Povidone-iodine And normal salin treatmentDRUG

use of Povidone-iodine And normal salin treatment for irrigation of ununion laparatomy or episiotomy wound.

Povidone-iodine And normal salin

Eligibility Criteria

Age10 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • all the women coming to Shariati hospital or Gynecologist's office with complain of ununion wound of laparatomy or episiotomy enroll to this study

You may not qualify if:

  • patients not satisfacted to participant in the study exclude of it

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bandarabbas

Bandarabbas, Hormozgan, Iran

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Interventions

WaterSoapsPovidone-Iodine

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsDetergentsSurface-Active AgentsSpecialty Uses of ChemicalsChemical Actions and UsesHousehold ProductsTechnology, Industry, and AgricultureIodophorsIodine CompoundsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured Materials

Study Officials

  • Aida Najafian

    Hormozgan University of Medical Science (HUMS)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aida Najafian, Specialist

CONTACT

+989133090692dr.aidanajafian@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Specialist

Study Record Dates

First Submitted

January 19, 2012

First Posted

June 14, 2012

Study Start

August 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

October 10, 2012

Record last verified: 2012-10

Locations

IR(1)