Role of Local Skin Incision Infiltration by Oxytocin On Wound Healing

Role of Local Skin Incision Infiltration by Oxytocin On Wound Healing of Caesarean Section Scar in Primiparous Women A Double Blind Randomized Controlled Study

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

Study Overview

• Status: Recruiting
• Conditions: Wound Heal; Scar; Previous Cesarean Section
• Intervention / Treatment: Drug: Oxytocin

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Assem Anour, Professor; Phone Number: 01118996837; Email: dramoussa77@hotmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Al Amerya hospital
    • Contact: EHAB ELTAYEB, Specialist; Phone Number: +201112455012; Email: ehab.eltayeb83@gmail.com
    • Sub-Investigator: Ismail Talat El-Gharhi, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; 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.	Drug: Oxytocin; This study will include 100 elective cesarean section in parous women who will be randomized into two groups each of 50 patients,; Other Names: Syntoinon
Experimental: Group B; 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.	Drug: Oxytocin; This study will include 100 elective cesarean section in parous women who will be randomized into two groups each of 50 patients,; Other Names: Syntoinon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	from baseline to 6 days after the Cesarean operation
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.	From base line to 6 hours postoperatively

Collaborators and Investigators

• Sponsor: Egymedicalpedia
• Investigators: Principal Investigator: Assem Anour, Professor, Al-Azhar University, Faculty of medicine for boys

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 15, 2025

Study Registration Dates

• First Submitted: February 12, 2023
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 14, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Oxytocin; wound complications; wound healing; caesarean Section scar
• Additional Relevant MeSH Terms: Wounds and Injuries; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: Assem Anour

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No