Role of Local Skin Incision Infiltration by Oxytocin On Wound Healing

Wound Heal Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05745935
• Other study ID #: Assem Anour
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: March 15, 2025

Study information

• Verified date: October 2023
• Source: Egymedicalpedia
• Contact: Assem Anour, Professor
• Phone: 01118996837
• Email: dramoussa77[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 15, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Scar; Previous Cesarean Section
• Wound Heal
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Egypt	Al Amerya hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Egymedicalpedia

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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