The objective of this study was the effect of Hypericum Perforatum (Perforan) on wound healing of episiotomy. 120 primiparous mothers with singleton pregnancy for whom episiotomy had been done after uncomplicated normal vaginal delivery were randomly allocated into either intervention or control group. Subjects with any acute or chronic systemic diseases, hypersensitivity, severe wound infection at fifth day after delivery or allergy to Hypericum Perforatum derivatives were excluded. Intervention under study was using Hypericum Perforatum ointment (three times a day for to 10 days) and Patients in control group received placebo ointment. Main outcome measures were pain on wound site, wound site edema, wound infection, suppurative secretion, number of remained sutures at fifth and tenth day after delivery, and wound dehiscence.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT201505061557N5
Registration date:2015-06-27, 1394/04/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-27, 1394/04/06
Registrant information
Name
Katayon Vakilian
Name of organization / entity
Arak University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 86 1417 3502
Email address
k_vakili@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2014-10-07, 1393/07/15
Expected recruitment end date
2015-03-06, 1393/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Hypericum Perforatum (Perforan) on wound healing episiotomy in women
Public title
Clinical trial the effect of Hypericum Perforatum (Perforan) on wound healing episiotomy in women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: singleton pregnancy;primiparous; episiotomy
Exclusion criteria: severe infection in 5th day after episiotomy; any acute or chronic diseases or allergy to Hypericum Perforatum
Age
From 16 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
random allocation
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Educational Complex campus, Basij Square, Sardasht, arak, Markazi, Iran, Islamic Republic Of
City
Arak
Postal code
3848176941
Approval date
2014-02-03, 1392/11/14
Ethics committee reference number
92-158-8
Health conditions studied
1
Description of health condition studied
Episiotomy during vaginal delivery
ICD-10 code
o90.1
ICD-10 code description
Disruption of wound of; episiotomy
Primary outcomes
1
Description
pain
Timepoint
Before intervention, 5 and 10 day after intervention
Method of measurement
visual analogue scale
2
Description
Discharge
Timepoint
Before the intervention, 5 and 10 days after the intervention
Method of measurement
Presence of suppurative vaginal discharge
3
Description
remained sutures
Timepoint
Before the intervention, 5 and 10 days after the intervention
Method of measurement
number of remained sutures
4
Description
Dehiscence
Timepoint
10th day after intervention
Method of measurement
Incidence of wound dehiscence
5
Description
Edema
Timepoint
Before the intervention, 5 and 10 days after the intervention
Method of measurement
Diameter of edema on wound site in Centimiter
6
Description
Redness
Timepoint
Before the intervention, 5 and 10 days after the intervention
Method of measurement
Diameter of redness in millimeter
Secondary outcomes
1
Description
Infection
Timepoint
Before the intervention, 5 and 10 days after the intervention
Method of measurement
Presence of infective discharge and dehiscence of wound
Intervention groups
1
Description
intervention group:Hypericum Perforatum (Perforan) ointment, Combined Vaseline with Hypericum Perforatum extracts, 25% concentration, three times daily for 10 days, POURSINA PHARMACEUTICAL COMPANY
Category
Prevention
2
Description
Control group: Vaseline ointment, three times daily for 10 days, POURSINA PHARMACEUTICAL COMPANY