Wound HealNCT05745935
Role of Local Skin Incision Infiltration by Oxytocin On Wound Healing
A study testing Oxytocin in people with Wound Heal and Scar; Previous Cesarean Section, run by Egymedicalpedia at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Wound Heal, Scar; Previous Cesarean Section
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 9Show fewer
- Primiparous women with known connective tissue disease and
- Women suffering from chronic diseases such as diabetes, hypertension, cardiovascular diseases, psychiatric diseases, cancer
- Smoking Women
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al Amerya hospital
Cairo
EHAB ELTAYEB, Specialist, +201112455012, ehab.eltayeb83@gmail.com
Ismail Talat El-Gharhi, Professor
About this study
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
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
Read the 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
- Being tested
- Oxytocin
- Keywords
- wound healing, Oxytocin, caesarean Section scar, wound complications
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Syntoinon
This study will include 100 elective cesarean section in parous women who will be randomized into two groups each of 50 patients,
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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. Receives: Drug: Oxytocin |
| Group B | Experimental | 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. Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From base line to 6 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Mar 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Assem Anour, Professor, Principal investigator, Al-Azhar University, Faculty of medicine for boys
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745935
- Sponsor's protocol ID
- Assem Anour
- Status last verified
- Oct 2023
- First submitted
- 12 Feb 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05745935
- Acronym / sponsor ID
- Assem Anour
- Conditions
- Wound Heal, Scar; Previous Cesarean Section
- Keywords
- wound healing, Oxytocin, caesarean Section scar, wound complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: OxytocinAbout 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 B | Experimental | Drug: OxytocinAbout 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Multiparous women,
- Assisted vaginal delivery,
- Normal vaginal delivery,
- Emergency caesarean section,
- Preterm pre labour rupture of membrane,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinAlso: SyntoinonThis study will include 100 elective cesarean section in parous women who will be randomized into two groups each of 50 patients, | Drug | Group A, Group B |
Primary outcome
Wound healing after Oxytocin injecton
Time frame: 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.
Pain Relief
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Assem Anour, Professor principal investigator
Al-Azhar University, Faculty of medicine for boys
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin in people with Wound Heal and Scar; Previous Cesarean Section, run by Egymedicalpedia at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Assem Anour, Professor (01118996837, dramoussa77@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing after Oxytocin injecton (time frame: from baseline to 6 days after the Cesarean operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.