Clinical trial NCT02664285: Closure Versus Non Closure of Subcutaneous Tissue After Cesarean Section in Diabetic Patients
Official title: Closure Versus Non Closure of Subcutaneous Tissue After Cesarean Section in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Delivery
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 136
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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:

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.

Eligibility criteria: Inclusion Criteria:

1. Pregnant women in childbearing period (18-45 years).
2. Women planned for elective cesarean section.
3. Pregnant women with gestational diabetes according to medical records.

Exclusion Criteria:

1. Hemoglobin less than 10g/dl.
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.

Primary outcomes:
measure: Number of participants with surgical site infection
timeFrame: 9 months
Secondary outcomes:
measure: Number of participants with wound seroma
timeFrame: month
measure: Number of participants with postoperative pain
timeFrame: 24 hours
measure: Number of participants with postoperative fever
timeFrame: 48 hours
measure: Number of participants with cosmetic wound
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References: