Role of Local Skin Incision Infiltration by Oxytocin On Wound Healing

NCT ID: NCT05745935

Last Updated: 2023-10-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-03-15

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.

Conditions

Wound Heal; Scar; Previous Cesarean Section

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

This study will include 100 elective cesarean section in parous women who will be randomized into two groups each of 50 patients,

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.

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

This study will include 100 elective cesarean section in parous women who will be randomized into two groups each of 50 patients,

Interventions

Oxytocin

This study will include 100 elective cesarean section in parous women who will be randomized into two groups each of 50 patients,

Intervention Type: DRUG

Other Intervention Names

Syntoinon

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Egymedicalpedia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Assem Anour, Professor

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University, Faculty of medicine for boys

Locations

Al Amerya hospital

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Assem Anour, Professor

Role: CONTACT

dramoussa77@hotmail.com

01118996837

Facility Contacts

EHAB ELTAYEB, Specialist

Role: primary

ehab.eltayeb83@gmail.com

+201112455012

Other Identifiers

Assem Anour

Identifier Type: -

Identifier Source: org_study_id