cs: Removal Versus Non Removal of Ceserean Section Scar .

• Sponsor: Assiut University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05150678
• Collaborator: (none)
• Enrollment: 600
• Arms: 2
• Anticipated Duration (Months): 20

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cesarean Wound; Dehiscence	Procedure: removal of ceserean section scar; Procedure: non removal of cesearean section scar	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: there are two gruops in the study ;one with removal of the scar 2nd with non removal in repeated csthere are two gruops in the study ;one with removal of the scar 2nd with non removal in repeated cs
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: EXCISION of CAESAREAN SECTION SKIN SCAR AND SUBCUTANEOUS RELEASE VERSUS NON REMOVAL IN REPEATED CAESAREAN SECTION.
• Anticipated Study Start Date: Apr 1, 2022
• Anticipated Primary Completion Date: Nov 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. the healing score [through the study duration AVERAGE ONE YEAR.]

   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 .

Secondary Outcome Measures

1. the cosmotic appereance of the scar [through the study duration an average one year]

   we will follow up the scar healing postoperative by the observer scale assessment score and the patient scar assessment scale .

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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. Review.
• 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.

• Responsible Party: mayada aboelmagd mohamed, principle investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT05150678
• Other Study ID Numbers: obstetric and gynacology
• First Posted: Dec 9, 2021
• Last Update Posted: Feb 1, 2022
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 1, 2022