Cesarean Wound; DehiscencecsNCT05150678
Removal Versus Non Removal of Ceserean Section Scar .
A study testing removal of ceserean section scar and non removal of cesearean section scar in people with Cesarean Wound; Dehiscence, run by Assiut University.
Trial summary
EXCISION of cs section skin scar and subcutaneous release versus non removal in repeated cs .aRandomized controlled trial . Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Wound; Dehiscence
- What is being tested?
- removal of ceserean section scar and non removal of cesearean section scar
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to Dec 2023
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- women with repeated ceserean section
- pregnant women >32 wk
Who cannot join
- DM bleeding tendency preeclampsia previous history of wound infection chronic steroid use women refused to participate in Randomized clinical trial
About this study
Official title: 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 .
Read the 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 .
- Conditions
- Cesarean Wound; Dehiscence
- Being tested
- removal of ceserean section scar, non removal of cesearean section scar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
removal of ceserean section scarProcedure or surgery
we will remove the previous scar in group A
non removal of cesearean section scarProcedure or surgery
we will open in the previous cesearean scar in group B
| Study group | Role | What they receive |
|---|---|---|
| removal of cs scar | Experimental | gruop 1 will remove the scar Receives: 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 Receives: Procedure: removal of ceserean section scar; Procedure: non removal of cesearean section scar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: through the study duration AVERAGE ONE YEAR.
Secondary outcomes (1)
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 .
Measured: through the study duration an average one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study startApr 2022 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cesarean Wound; DehiscenceStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- there are two gruops in the study ;one with removal of the scar 2nd with non removal in repeated cs
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mayada aboelmagd mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150678
- Sponsor's protocol ID
- obstetric and gynacology
- Acronym
- cs
- Status last verified
- Nov 2021
- First submitted
- 17 Sep 2021
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 19646316Kawakita 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.
PubMed 28690864
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXCISION of CAESAREAN SECTION SKIN SCAR AND SUBCUTANEOUS RELEASE VERSUS NON REMOVAL IN REPEATED CAESAREAN SECTION.
- ClinicalTrials.gov ID
- NCT05150678
- Acronym / sponsor ID
- cs / obstetric and gynacology
- Conditions
- Cesarean Wound; Dehiscence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 9 Dec 2021 (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.
EXCISION of cs section skin scar and subcutaneous release versus non removal in repeated cs .aRandomized controlled trial .
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- there are two gruops in the study ;one with removal of the scar 2nd with non removal in repeated cs
| Arm | Type | Receives |
|---|---|---|
| removal of cs scar | Experimental | Procedure: removal of ceserean section scar, Procedure: non removal of cesearean section scargruop 1 will remove the scar |
| non removal of the scar | Experimental | Procedure: removal of ceserean section scar, Procedure: non removal of cesearean section scargruop2 will not remove the scar |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- women with repeated ceserean section
- pregnant women >32 wk
Key exclusion criteria (1 listed)
- DM bleeding tendency preeclampsia previous history of wound infection chronic steroid use women refused to participate in Randomized clinical trial
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 |
|---|---|---|
| removal of ceserean section scarwe will remove the previous scar in group A | Procedure or surgery | non removal of the scar, removal of cs scar |
| non removal of cesearean section scarwe will open in the previous cesearean scar in group B | Procedure or surgery | non removal of the scar, removal of cs scar |
Primary outcome
the healing score
Time frame: 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 .
1 secondary outcome
the cosmotic appereance of the scar
Time frame: through the study duration an average one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Background: PubMed 19646316Altman 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.
- Background: PubMed 28690864Kawakita 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing removal of ceserean section scar and non removal of cesearean section scar in people with Cesarean Wound; Dehiscence, run by Assiut University.
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 2 inclusion and 1 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 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the healing score (time frame: through the study duration AVERAGE ONE YEAR.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05150678, which also lists 2 linked publications.
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 1 Feb 2022.