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Soap Versus Normal Salin Plus Povidone-iodine in Ununion Wound

Primary Purpose

Wound

Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
water and soap
Povidone-iodine And normal salin treatment
Sponsored by
Aida Najafian
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound focused on measuring ununion wound, soap, irrigation, Povidone-iodine, normal salin

Eligibility Criteria

10 Years - 60 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • BandarabbasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Povidone-iodine And normal salin

water and soap

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

number of admission day
number of days the patients in each group admitted in hospital

Secondary Outcome Measures

complication of each treatment
complications include of : infection, reopening of wound, and measurment of opening of wound.

Full Information

First Posted
January 19, 2012
Last Updated
October 5, 2012
Sponsor
Aida Najafian
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1. Study Identification

Unique Protocol Identification Number
NCT01619137
Brief Title
Soap Versus Normal Salin Plus Povidone-iodine in Ununion Wound
Official Title
Comparison of the Effect of Water and Soap Irrigation With With Povidone-iodine And Normal Salin Treatment of Patients With Ununion Laparatomy or Episiotomy Wound ( a Pilot Study)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aida Najafian

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)
Detailed Description
IN 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), We use soap in one group and Povidone-iodine And normal salin in other group for irrigation of ununion laparatomy or episiotomy wound.it's require the patients in Povidone-iodine And normal salin group be at hospital till wound be able to closed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound
Keywords
ununion wound, soap, irrigation, Povidone-iodine, normal salin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Povidone-iodine And normal salin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
water and soap
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
water and soap
Intervention Description
water and soap for 6-8 hours per day.
Intervention Type
Drug
Intervention Name(s)
Povidone-iodine And normal salin treatment
Intervention Description
use of Povidone-iodine And normal salin treatment for irrigation of ununion laparatomy or episiotomy wound.
Primary Outcome Measure Information:
Title
number of admission day
Description
number of days the patients in each group admitted in hospital
Time Frame
1 month
Secondary Outcome Measure Information:
Title
complication of each treatment
Description
complications include of : infection, reopening of wound, and measurment of opening of wound.
Time Frame
1 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all the women coming to Shariati hospital or Gynecologist's office with complain of ununion wound of laparatomy or episiotomy enroll to this study Exclusion Criteria: patients not satisfacted to participant in the study exclude of it
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aida Najafian, Specialist
Phone
+989133090692
Email
dr.aidanajafian@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aida Najafian
Organizational Affiliation
Hormozgan University of Medical Science (HUMS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bandarabbas
City
Bandarabbas
State/Province
Hormozgan
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aida Najafian, specialist
Phone
+989133090692
Email
dr.aidanajafian@yahoo.com
First Name & Middle Initial & Last Name & Degree
Aida Najafian, specialist

12. IPD Sharing Statement

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Soap Versus Normal Salin Plus Povidone-iodine in Ununion Wound

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