Closure Versus Non Closure of Subcutaneous Tissue After Cesarean Section in Diabetic Patients
NCT ID: NCT02664285
Last Updated: 2016-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
136 participants
INTERVENTIONAL
2016-01-31
2016-10-31
Brief Summary
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Detailed Description
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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:
1. History Full history taking, (personal, present, past and obstetrics history).
2. Clinical examination including:
General examination:
1. Assessment of vital data
2. Assessment of general condition.
3. 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.
8\. The wound is to be inspected 48 hours, 7 days and one month after the cesarean section.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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closure of subcutaneous tissue
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.
closure of subcutaneous tissue
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 tissue
in diabetic patients, the subcutaneous fat will not sutured after cesarean section.
No closure of subcutaneous tissue
the subcutaneous fat will not sutured after cesarean section in diabetic patients.
Interventions
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closure of subcutaneous tissue
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 tissue
the subcutaneous fat will not sutured after cesarean section in diabetic patients.
Eligibility Criteria
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Inclusion Criteria
2. Women planned for elective cesarean section.
3. Pregnant women with gestational diabetes according to medical records.
Exclusion Criteria
2. Intra operative events that may themselves predispose to postoperative infection (e.g. operative time more than 90 minutes).
3. Rupture of membrane more than 12 hours.
4. Receive corticosteroid medications.
5. Immunosuppressive disease or Auto immune disease.
6. Concurrent infection (e.g. signs of pyelonephritis, chest infection).
7. Previous history of two C.S.
8. Previous laparotomy other than C.S.
18 Years
45 Years
FEMALE
Yes
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Rehab Mohamed Abdelrahman
Lecturer of Obstetrics and Gynaecology Faculty of Medicine, Ain Shams University
Other Identifiers
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ceserean section
Identifier Type: -
Identifier Source: org_study_id