Abdominal DeliveryNCT02664285
Closure Versus Non Closure of Subcutaneous Tissue After Cesarean Section in Diabetic Patients
A study testing closure of subcutaneous tissue and No closure of subcutaneous tissue in people with Abdominal Delivery, run by Ain Shams University.
Trial summary
The aim of this study is to determine the surgical site infection rate and the patient's satisfaction for closure of subcutaneous tissue versus non closure of subcutaneous tissue after cesarean delivery in women with diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abdominal Delivery
- What is being tested?
- closure of subcutaneous tissue and No closure of subcutaneous tissue
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Oct 2016
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women in childbearing period (18-45 years).
- Women planned for elective cesarean section.
- Pregnant women with gestational diabetes according to medical records.
Who cannot join
- Hemoglobin less than 10g/dl.
- Intra operative events that may themselves predispose to postoperative infection (e.g. operative time more than 90 minutes).
- Rupture of membrane more than 12 hours.
- Receive corticosteroid medications.
- Immunosuppressive disease or Auto immune disease.
- Concurrent infection (e.g. signs of pyelonephritis, chest infection).
- Previous history of two C.S.
- Previous laparotomy other than C.S.
About this study
The aim of this study is to determine the surgical site infection rate and the patient's satisfaction for closure of subcutaneous tissue versus non closure of subcutaneous tissue after cesarean delivery in women with diabetes mellitus.
Read the detailed description
This is a randomized prospective comparative clinical study will be conducted in Ain Shams University, Maternity Hospital.
This study will include a sample of (136) pregnant women with gestational diabetes mellitus and type 2 diabetes mellitus who underwent elective Cesarean section.
Patients will b divided into two groups:
Group A (closure group): will include 68 pregnant women who underwent elective Cesarean section with closure of subcutaneous tissue. Group B (non closure group): will include 68 pregnant women who underwent elective Cesarean section without closure of subcutaneous tissue.
- All participants in the study will have consent.
All included women will be subjected to the following:
- History Full history taking, (personal, present, past and obstetrics history).
- Clinical examination including:
General examination:
- Assessment of vital data
- Assessment of general condition.
- Cardiac and chest examination, to exclude any contraindication for anesthesia.
Abdominal examination:
Assessment of fundal level for fetal dating, fetal lie and fetal heart sound. 3. Investigations: Laboratory Complete blood picture.- Random blood sugar.
Ultrasonography:
Fetal biometry for fetal dating and fetal viability. 4. All participants operated under general or spinal anesthesia. Prophylactic antibiotic is given according to the approved protocol of Ain Shams Maternity Hospital (as two intravenous doses of broad spectrum penicillin (after clamping of the umbilical cord and 12 hours postoperatively. Oral antibiotic of the same group was then started for 3-5 days.
5.In group A (closure group)the subcutaneous fat will be closed with three to five interrupted sutures. The sutures were tied until the tissue was adequately re-approximated, but not as hard as possible to avoid necrosis. In group B (non closure group) the subcutaneous fat will not sutured.
6.In all participants Skin to be closed by subcuticular stitches using absorbable polyglactin 910 suture 7. Dressing is removed after 48hours postoperatively, to be disinfected with alcohol 70% antiseptic solution daily in both groups.
- The wound is to be inspected 48 hours, 7 days and one month after the cesarean section.
- Conditions
- Abdominal Delivery
- Being tested
- closure of subcutaneous tissue, No closure of subcutaneous tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closure of subcutaneous tissueOther
the subcutaneous fat will be closed with three to five interrupted sutures. The sutures were tied until the tissue was adequately re-approximated, but not as hard as possible to avoid necrosis after cesarean section in diabetic patients.
No closure of subcutaneous tissueOther
the subcutaneous fat will not sutured after cesarean section in diabetic patients.
| Study group | Role | What they receive |
|---|---|---|
| closure of subcutaneous tissue | Other | in diabetic patients, the subcutaneous fat will be closed with three to five interrupted sutures. The sutures were tied until the tissue was adequately re-approximated, but not as hard as possible to avoid necrosis after cesarean section. Receives: Other: closure of subcutaneous tissue |
| No closure of subcutaneous tissue | Other | in diabetic patients, the subcutaneous fat will not sutured after cesarean section. Receives: Other: No closure of subcutaneous tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with surgical site infection
Surgical site infection: including the following manifestations: Collection; inflammatory signs (pain, tenderness, edema, redness); dehiscence (wound separation) or positive culture.
Measured: 9 months
Secondary outcomes (4)
Number of participants with wound seroma
wound seroma, superficial wound breakdown (defined as skin and/or subcutaneous dehiscence with intact fascial layer).
Measured: month
Number of participants with postoperative pain
Postoperative pain (judged after 24 hours, through visual analogue scale (VAS); with 0 meaning no pain, and 10 meaning the worst pain).
Measured: 24 hours
Number of participants with postoperative fever
postoperative fever (defined as temperature more than thirty eight degree, 48 hours postoperative.
Measured: 48 hours
Number of participants with cosmetic wound
Is cosmetic wound outcome for one month postoperative good or no?
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal DeliveryStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Mohamed Abdelrahman, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664285
- Sponsor's protocol ID
- ceserean section
- Status last verified
- Nov 2016
- First submitted
- 20 Jan 2016
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The aim of this study is to determine the surgical site infection rate and the patient's satisfaction for closure of subcutaneous tissue versus non closure of subcutaneous tissue after cesarean delivery in women with diabetes mellitus.
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closure Versus Non Closure of Subcutaneous Tissue After Cesarean Section in Diabetic Patients
- ClinicalTrials.gov ID
- NCT02664285
- Acronym / sponsor ID
- ceserean section
- Conditions
- Abdominal Delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 27 Jan 2016 (estimated)
- 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.
The aim of this study is to determine the surgical site infection rate and the patient's satisfaction for closure of subcutaneous tissue versus non closure of subcutaneous tissue after cesarean delivery in women with diabetes mellitus.
Detailed description
This is a randomized prospective comparative clinical study will be conducted in Ain Shams University, Maternity Hospital.
This study will include a sample of (136) pregnant women with gestational diabetes mellitus and type 2 diabetes mellitus who underwent elective Cesarean section.
Patients will b divided into two groups:
Group A (closure group): will include 68 pregnant women who underwent elective Cesarean section with closure of subcutaneous tissue. Group B (non closure group): will include 68 pregnant women who underwent elective Cesarean section without closure of subcutaneous tissue.
- All participants in the study will have consent.
All included women will be subjected to the following:
- History Full history taking, (personal, present, past and obstetrics history).
- Clinical examination including:
General examination:
- Assessment of vital data
- Assessment of general condition.
- Cardiac and chest examination, to exclude any contraindication for anesthesia.
Abdominal examination:
Assessment of fundal level for fetal dating, fetal lie and fetal heart sound. 3. Investigations: Laboratory Complete blood picture.- Random blood sugar.
Ultrasonography:
Fetal biometry for fetal dating and fetal viability. 4. All participants operated under general or spinal anesthesia. Prophylactic antibiotic is given according to the approved protocol of Ain Shams Maternity Hospital (as two intravenous doses of broad spectrum penicillin (after clamping of the umbilical cord and 12 hours postoperatively. Oral antibiotic of the same group was then started for 3-5 days.
5.In group A (closure group)the subcutaneous fat will be closed with three to five interrupted sutures. The sutures were tied until the tissue was adequately re-approximated, but not as hard as possible to avoid necrosis. In group B (non closure group) the subcutaneous fat will not sutured.
6.In all participants Skin to be closed by subcuticular stitches using absorbable polyglactin 910 suture 7. Dressing is removed after 48hours postoperatively, to be disinfected with alcohol 70% antiseptic solution daily in both groups.
- The wound is to be inspected 48 hours, 7 days and one month after the cesarean section.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| closure of subcutaneous tissue | Other | Other: closure of subcutaneous tissuein diabetic patients, the subcutaneous fat will be closed with three to five interrupted sutures. The sutures were tied until the tissue was adequately re-approximated, but not as hard as possible to avoid necrosis after cesarean section. |
| No closure of subcutaneous tissue | Other | Other: No closure of subcutaneous tissuein diabetic patients, the subcutaneous fat will not sutured after cesarean section. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women in childbearing period (18-45 years).
- Women planned for elective cesarean section.
- Pregnant women with gestational diabetes according to medical records.
Key exclusion criteria (8 listed)
- Hemoglobin less than 10g/dl.
- Intra operative events that may themselves predispose to postoperative infection (e.g. operative time more than 90 minutes).
- Rupture of membrane more than 12 hours.
- Receive corticosteroid medications.
- Immunosuppressive disease or Auto immune disease.
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 |
|---|---|---|
| closure of subcutaneous tissuethe subcutaneous fat will be closed with three to five interrupted sutures. The sutures were tied until the tissue was adequately re-approximated, but not as hard as possible to avoid necrosis after cesarean section in diabetic patients. | Other | closure of subcutaneous tissue |
| No closure of subcutaneous tissuethe subcutaneous fat will not sutured after cesarean section in diabetic patients. | Other | No closure of subcutaneous tissue |
Primary outcome
Number of participants with surgical site infection
Time frame: 9 months
Surgical site infection: including the following manifestations: Collection; inflammatory signs (pain, tenderness, edema, redness); dehiscence (wound separation) or positive culture.
4 secondary outcomes
Number of participants with wound seroma
Time frame: month
Number of participants with postoperative pain
Time frame: 24 hours
Number of participants with postoperative fever
Time frame: 48 hours
Number of participants with cosmetic wound
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
- Individual participant dataSharing planned: Yes. The aim of this study is to determine the surgical site infection rate and the patient's satisfaction for closure of subcutaneous tissue versus non closure of subcutaneous tissue after cesarean delivery in women with diabetes mellitus.
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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 closure of subcutaneous tissue and No closure of subcutaneous tissue in people with Abdominal Delivery, run by Ain Shams 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 8 Nov 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with surgical site infection (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2016.