Clinical trial NCT05745935: 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
Overall status: RECRUITING
Phase: NA
Conditions: Wound Heal
Scar; Previous Cesarean Section
Keywords: wound healing
Oxytocin
caesarean Section scar
wound complications
Lead sponsor: Egymedicalpedia
Sponsor class: INDUSTRY
First posted: 2023-02-27
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Wound healing after Oxytocin injecton
timeFrame: from baseline to 6 days after the Cesarean operation
measure: Pain Relief
timeFrame: From base line to 6 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al Amerya hospital
Study officials:
affiliation: Al-Azhar University, Faculty of medicine for boys
name: Assem Anour, Professor
role: PRINCIPAL_INVESTIGATOR
References: