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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05150678
Other study ID # obstetric and gynacology
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2022
Est. completion date December 2023

Study information

Verified date November 2021
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

EXCISION of cs section skin scar and subcutaneous release versus non removal in repeated cs .aRandomized controlled trial .


Description:

All eligible participants will randimized into two groups ; gruop 1 skin removal in which we will going to remove skin scar gruop 2 skin non removal ;direct open in the middle of the previous scar Follow up will be recorded for each participant aphoto will be taken postoperative to score the healing of the wound the follow up will be at one week ,then one month ,then three month acomparison between the two groups will be done .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 600
Est. completion date December 2023
Est. primary completion date November 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: 1. women with repeated ceserean section 2. pregnant women >32 wk Exclusion Criteria: - DM bleeding tendency preeclampsia previous history of wound infection chronic steroid use women refused to participate in Randomized clinical trial

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
removal of ceserean section scar
we will remove the previous scar in group A
non removal of cesearean section scar
we will open in the previous cesearean scar in group B

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (2)

Altman AD, Allen VM, McNeil SA, Dempster J. Pfannenstiel incision closure: a review of current skin closure techniques. J Obstet Gynaecol Can. 2009 Jun;31(6):514-520. doi: 10.1016/S1701-2163(16)34213-X. Review. — View Citation

Kawakita T, Landy HJ. Surgical site infections after cesarean delivery: epidemiology, prevention and treatment. Matern Health Neonatol Perinatol. 2017 Jul 5;3:12. doi: 10.1186/s40748-017-0051-3. eCollection 2017. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary the healing score we will follow up the scar postoperative to compare the healing score by observer scar assessment scale maximaum score 5and patient scar assessment scale.maximum score 10.means WORST scale . through the study duration AVERAGE ONE YEAR.
Secondary the cosmotic appereance of the scar we will follow up the scar healing postoperative by the observer scale assessment score and the patient scar assessment scale . through the study duration an average one year
See also
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Completed NCT05166174 - Lower Uterine Segment Following a Cesarean Section With Barbed Suture
Completed NCT04198324 - Isthmocele After Endometrial and Non-endometrial Suturing in Cesarean Section N/A
Completed NCT04371549 - Skin Closures at Cesarean Delivery, Glue vs Subcuticular Sutures. N/A
Completed NCT03609281 - Cesarean Scar Characteristics After Scheduled and Emergency Cesarean Deliveries
Completed NCT03414762 - PICO Negative Pressure Wound Therapy in Obese Women Undergoing Elective Cesarean Delivery. Phase 3