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The effect of spray silver nano-particles (Nyvasha) on cesarean section wound healing in women

Protocol summary

Summary
The present study analyses the effect of silver nano-particles spray on healing of caesarian section wound. This study is done on 90 women referred to Omol-Banin and Imam Reza educational hospital of Mashhad for caesarian section surgery. The women's consent to participate in this research has been acquired. The groups under research are chosen on the basis of entry criterion (by available sampling method) and, then, based on a random allocation method (by the use of SPSS software), they fall into two intervention and one control group. Inclusion criteria include: Patient's consent to participate in this study; have minimum level of literacy; iranian; term pregnancy (37-42 weeks); 18 to 35 years of age; cesarean with beneath cut; initial cesarean section; body mass index in the range of 18.5-25 in early pregnancy; no complications of pregnancy (eclampsia, preclampsia , corioamniotitis, twin pregnancy, poly hydroamnios ); no acute or chronic illness; no-disruptive healing (disease i.e diabetes, kidney disease, anemia, liver disease, mental; not having any abnormality in the fetus ; non-consumption of drugs and tobacco; non-use of drugs affecting wound healing (glucocorticoids, anticoagulants, immunosuppressant drugs and chemotherapy). Exclusion criteria include: Unwillingness to continue cooperation; major bleeding or need for blood transfusion, hysterectomy and myomectomy with cesarean section; prolonged operation for more than 60 minutes; wound infection; irregular spray use and as directed; complications arising from the use of spray; infancy in NICU.. The first two invention groups receive Nyvasha and placebo spray on the caesarian wound twice a day for 10 consecutive days and each time 3 puffs. The control group does not receive any drugs; they just receive routine care. The researcher sees them on 5th and 10th days after the caesarian section surgery. Just after the caesarian section (24 ± 4 hours) and on the 5th and 10th days after it, the healing process of sutures are checked out on the basis of Reeda's scale. The results will be put in Reeda's scale form.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017043033716N1
Registration date: 2017-11-16, 1396/08/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-11-16, 1396/08/25
Registrant information
Name
Zakieh Boroumand
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3768 4212
Email address
boroumandz941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Mashhad University of Medical Sciences
Expected recruitment start date
2017-07-06, 1396/04/15
Expected recruitment end date
2017-10-07, 1396/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of spray silver nano-particles (Nyvasha) on cesarean section wound healing in women
Public title
The effect of Nyvasha spray on cesarean wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria include: Patient's consent to participate in this study; have minimum level of literacy; Iranian; term pregnancy (37-42 weeks); 18 to 35 years of age; cesarean with beneath cut; initial cesarean section; body mass index in the range of 18.5-25 in early pregnancy; no complications of pregnancy (eclampsia, preclampsia , corioamniotitis, twin pregnancy, poly hydroamnios ); no acute or chronic illness; no-disruptive healing (disease i.e diabetes, kidney disease, anemia, liver disease, mental; not having any abnormality in the fetus ; non-consumption of drugs and tobacco; non-use of drugs affecting wound healing (glucocorticoids, anticoagulants, immunosuppressant drugs and chemotherapy). Exclusion criteria include: Unwillingness to continue cooperation; major bleeding or need for blood transfusion, hysterectomy and myomectomy with cesarean section; prolonged operation for more than 60 minutes; wound infection; irregular spray use and as directed; complications arising from the use of spray; infancy in NICU.
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Scienes
Street address
Ghoreshi building, Daneshgah street
City
Mashhad
Postal code
9138813944
Approval date
2017-06-12, 1396/03/22
Ethics committee reference number
IR.MUMS.REC.1396.8

Health conditions studied

1

Description of health condition studied
Cesarean
ICD-10 code
090.0
ICD-10 code description
Disruption of caesarean section wound

Primary outcomes

1

Description
Wound healing
Timepoint
After cesarean section (24 ±4 hours) and 5th and 10th days after the caesarian section
Method of measurement
Reeda Scale

Secondary outcomes

1

Description
Pain
Timepoint
After cesarean section (24 ±4 hours) and 5th and 10th days after the caesarian section
Method of measurement
Pain visual analog scale

Intervention groups

1

Description
Intervention group 1: The silver nano-particles spray (Nyvasha) is put at a distance of 10 cm from caesarian wound; three puffs are sprayed on the beginning, middle and end of the wound respectively. Twice a day for 10 consecutive days, and each time 3 puffs, is prescribed.
Category
Treatment - Drugs

2

Description
Intervention group 2: Spray serum that contains a simple base wash (placebo) is put on caesarean section wound at a distance of 10 cm from the wound. Three puffs are sprayed on the beginning, middle and end of the scar respectively. Twice a day for 10 consecutive days, and each time 3 puffs, is prescribed.
Category
Placebo

3

Description
Control group: Control group do not receive any drugs; they just receive routine care. The researcher sees them on 5th and 10th days after the caesarian section surgery.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Omol-Banin Hospital
Full name of responsible person
Bibi Hasanzadeh
Street address
Ayatolah Bahjat Street
City
Mashhad

2

Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Ghadernia
Street address
Ebnesina Street
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ethics committee of Mashhad University of Medical Scienes
Full name of responsible person
Mohsen Tafaghodi
Street address
Ghoreshi building, Daneshgah street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ethics committee of Mashhad University of Medical Scienes
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zakieh Boroumand
Position
Midwifery Master
Other areas of specialty/work
Street address
Ebnesina Street, School of Nursing and Midwifery
City
Mashhad
Postal code
Phone
+98 51 3768 4212
Fax
Email
Boroumandz941@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Golmakani
Position
Midwifery Master, Assistant Professor
Other areas of specialty/work
Street address
Ebnesina Street, Mashhad
City
Mashhad
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 1859 7313
Email
Golmakanin@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zakieh Boroumand
Position
Midwifery Master
Other areas of specialty/work
Street address
Ebnesina Street, School of Nursing and Midwifery
City
Mashhad
Postal code
Phone
+98 51 3768 4212
Fax
Email
Boroumandz941@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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