Removal Versus Non Removal of Ceserean Section Scar . (cs)

EXCISION of CAESAREAN SECTION SKIN SCAR AND SUBCUTANEOUS RELEASE VERSUS NON REMOVAL IN REPEATED CAESAREAN SECTION.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cesarean Wound; Dehiscence
• Intervention / Treatment: Procedure: removal of ceserean section scar; Procedure: non removal of cesearean section scar

Detailed 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 .

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: removal of cs scar; gruop 1 will remove the scar	Procedure: removal of ceserean section scar; we will remove the previous scar in group A; Procedure: non removal of cesearean section scar; we will open in the previous cesearean scar in group B
Experimental: non removal of the scar; gruop2 will not remove the scar	Procedure: removal of ceserean section scar; we will remove the previous scar in group A; Procedure: non removal of cesearean section scar; we will open in the previous cesearean scar in group B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: November 26, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): February 1, 2022
• Last Update Submitted That Met QC Criteria: January 17, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: obstetric and gynacology

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No