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Role of Local Skin Incision Infiltration by Oxytocin On Wound Healing

Primary Purpose

Wound Heal, Scar; Previous Cesarean Section

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Oxytocin
Sponsored by
Egymedicalpedia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Heal focused on measuring wound healing, Oxytocin, caesarean Section scar, wound complications

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Primigravidae women, Age group from 20- 35 years old. Gestational age 37-41 weeks, and Elective caesarean section due to obstetrics indication. The patient signed an Informed Consent Form authorizing their inclusion Exclusion Criteria: Multiparous women, Assisted vaginal delivery, Normal vaginal delivery, Emergency caesarean section, Preterm pre labour rupture of membrane, Primiparous women with age above 35 years old, Primiparous women with known connective tissue disease and Women suffering from chronic diseases such as diabetes, hypertension, cardiovascular diseases, psychiatric diseases, cancer Smoking Women

Sites / Locations

  • Al Amerya hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

About 50 Patients Will receive 20 units of local oxytocin infiltration before skin closure . 10 units of oxytocin will be infiltrated at the upper skin edge and 10 units of oxytocin will be infilterated at the lower skin edges at equal intervals of 2 cm in between infiltration points.

About 50 Patients Will receive the 10 units of local oxytocin infiltration before skin closure . 5 units will be infiltrated at the upper skin edge and 5 units will be infiltrated at the lower skin edge at equal intervals of approximately 2 cm in between infiltration points.

Outcomes

Primary Outcome Measures

Wound healing after Oxytocin injecton
Injection of the Oxytocin hormon in the cesarean wound before closing it during cesarean delivery and close watching for healing process.
Pain Relief
The effect of oxytocin on pain relief using pain score scale, numerical pain score scale from 0-10 where 0 is no pain, from 1-3 is mild pain,4-6 moderate pain and from 7-10 is severe pain.

Secondary Outcome Measures

Full Information

First Posted
February 12, 2023
Last Updated
October 14, 2023
Sponsor
Egymedicalpedia
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1. Study Identification

Unique Protocol Identification Number
NCT05745935
Brief Title
Role of Local Skin Incision Infiltration by Oxytocin On Wound Healing
Official Title
Role of Local Skin Incision Infiltration by Oxytocin On Wound Healing of Caesarean Section Scar in Primiparous Women A Double Blind Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Egymedicalpedia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
caesarean section rate in Egypt has reached about 60% between primgravidae. Wound complications are of the most common morbidities following cesarean section. The prevalence of wound infection and disruption after cesarean has been reported as 3-15%, averagely speaking 6% and 2-42% in various studies. These complications affect mother's quality of life due to stress, anxiety, delay in mother's ability and health recovery
Detailed Description
Nowadays, cesarean is one of the most common surgical interventions and its prevalence has increased in most countries in the recent years. At present, all efforts are focused on the early and effective healing of caesarean skin wound and its associated complications. There is a wide range of topical and systemic treatments for the management of caesarean skin incision. Topical treatments have side effects and hence are not considered as the treatment of choice for such incisions. Oxytocin is a Nonapeptide hormone of a cyclic six amino-acid structure and a tail of three amino acids, responsible for initiation of the milk ejection reflex and stimulating the uterine contractions. However, other important roles of oxytocin include improvement of social life, exerting pain-relieving, anti anti-stress/anti-inflammatory and restorative effects, friendship and making social relationship with individual or group. However, other important roles of oxytocin include improvement of social life, exerting pain-relieving, anti anti-stress/anti-inflammatory and restorative effects, friendship and making social relationship with individual or group. In conclusion, oxytocin is linked to many different, sometimes opposite effects The intact cyclic molecule may act to initiate social interaction and associated psychophysiological effects, whereas linear oxytocin and C-terminal fragments may induce relaxation and anti-stress effects following social interaction. In this way, the principal hormone oxytocin and its fragments may take part in a behavioral sequence, ranging from approach and interaction to calm and relaxation. Linear fragments, with an exposed cysteine-residue, may exert anti-inflammatory and antioxidant effects and thereby contribute to the health-promoting effects of oxytocin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Heal, Scar; Previous Cesarean Section
Keywords
wound healing, Oxytocin, caesarean Section scar, wound complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
About 50 Patients Will receive 20 units of local oxytocin infiltration before skin closure . 10 units of oxytocin will be infiltrated at the upper skin edge and 10 units of oxytocin will be infilterated at the lower skin edges at equal intervals of 2 cm in between infiltration points.
Arm Title
Group B
Arm Type
Experimental
Arm Description
About 50 Patients Will receive the 10 units of local oxytocin infiltration before skin closure . 5 units will be infiltrated at the upper skin edge and 5 units will be infiltrated at the lower skin edge at equal intervals of approximately 2 cm in between infiltration points.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Syntoinon
Intervention Description
This study will include 100 elective cesarean section in parous women who will be randomized into two groups each of 50 patients,
Primary Outcome Measure Information:
Title
Wound healing after Oxytocin injecton
Description
Injection of the Oxytocin hormon in the cesarean wound before closing it during cesarean delivery and close watching for healing process.
Time Frame
from baseline to 6 days after the Cesarean operation
Title
Pain Relief
Description
The effect of oxytocin on pain relief using pain score scale, numerical pain score scale from 0-10 where 0 is no pain, from 1-3 is mild pain,4-6 moderate pain and from 7-10 is severe pain.
Time Frame
From base line to 6 hours postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primigravidae women, Age group from 20- 35 years old. Gestational age 37-41 weeks, and Elective caesarean section due to obstetrics indication. The patient signed an Informed Consent Form authorizing their inclusion Exclusion Criteria: Multiparous women, Assisted vaginal delivery, Normal vaginal delivery, Emergency caesarean section, Preterm pre labour rupture of membrane, Primiparous women with age above 35 years old, Primiparous women with known connective tissue disease and Women suffering from chronic diseases such as diabetes, hypertension, cardiovascular diseases, psychiatric diseases, cancer Smoking Women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Assem Anour, Professor
Phone
01118996837
Email
dramoussa77@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Assem Anour, Professor
Organizational Affiliation
Al-Azhar University, Faculty of medicine for boys
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al Amerya hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
EHAB ELTAYEB, Specialist
Phone
+201112455012
Email
ehab.eltayeb83@gmail.com
First Name & Middle Initial & Last Name & Degree
Ismail Talat El-Gharhi, Professor

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Role of Local Skin Incision Infiltration by Oxytocin On Wound Healing

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