Removal Versus Non Removal of Ceserean Section Scar .

NCT05150678 | Unknown

• 1 other identifier: obstetric and gynacology
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Cesarean Wound; Dehiscence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the cosmotic appereance of the scar

  through the study duration an average one year

Study Arms (2)

removal of cs scar

EXPERIMENTAL

gruop 1 will remove the scar

Procedure: removal of ceserean section scar; Procedure: non removal of cesearean section scar

non removal of the scar

EXPERIMENTAL

gruop2 will not remove the scar

Procedure: removal of ceserean section scar; Procedure: non removal of cesearean section scar

Interventions

removal of ceserean section scar PROCEDURE

we will remove the previous scar in group A

non removal of the scar; removal of cs scar

non removal of cesearean section scar PROCEDURE

we will open in the previous cesearean scar in group B

non removal of the scar; removal of cs scar

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• women with repeated ceserean section
• pregnant women \>32 wk

You may not qualify if:

• DM bleeding tendency preeclampsia previous history of wound infection chronic steroid use women refused to participate in Randomized clinical trial

Sponsors & Collaborators

• Assiut University: lead

Related 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.

  PMID: 19646316 BACKGROUND

• 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.

  PMID: 28690864 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: there are two gruops in the study ;one with removal of the scar 2nd with non removal in repeated cs

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: December 9, 2021
• Study Start: April 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 1, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share