Role of Local Skin Incision Infiltration by Oxytocin On Wound Healing

Sponsor
Egymedicalpedia (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05745935
Collaborator
(none)
120
1
2
24.5
4.9

Study Details

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

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Mar 15, 2025

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Wound healing after Oxytocin injecton [from baseline to 6 days after the Cesarean operation]

      Injection of the Oxytocin hormon in the cesarean wound before closing it during cesarean delivery and close watching for healing process.

    2. Pain Relief [From base line to 6 hours postoperatively]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Al Amerya hospital Cairo Egypt

    Sponsors and Collaborators

    • Egymedicalpedia

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Egymedicalpedia
    ClinicalTrials.gov Identifier:
    NCT05745935
    Other Study ID Numbers:
    • Assem Anour
    First Posted:
    Feb 27, 2023
    Last Update Posted:
    Feb 27, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Egymedicalpedia
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 27, 2023