Closure Versus Non Closure of Subcutaneous Tissue After Cesarean Section in Diabetic Patients

Not Applicable

Completed

• Conditions: Abdominal Delivery
• Interventions: Other: closure of subcutaneous tissue; Other: No closure of subcutaneous tissue

• Registration Number: NCT02664285
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-20
• Study First Submitted QC: 2016-01-22
• Study First Posted: 2016-01-27
• Primary Completion: 2016-09
• Study Completion: 2016-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-06
• Last Update Posted: 2016-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 136

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
closure of subcutaneous tissue	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.
No closure of subcutaneous tissue	No closure of subcutaneous tissue	in diabetic patients, the subcutaneous fat will not sutured after cesarean section.

Primary Outcome Measures

Name	Time	Method
Number of participants with surgical site infection	9 months	Surgical site infection: including the following manifestations: Collection; inflammatory signs (pain, tenderness, edema, redness); dehiscence (wound separation) or positive culture.

Secondary Outcome Measures

Name	Time	Method
Number of participants with cosmetic wound	1 month	Is cosmetic wound outcome for one month postoperative good or no?
Number of participants with postoperative pain	24 hours	Postoperative pain (judged after 24 hours, through visual analogue scale (VAS); with 0 meaning no pain, and 10 meaning the worst pain).
Number of participants with postoperative fever	48 hours	postoperative fever (defined as temperature more than thirty eight degree, 48 hours postoperative.
Number of participants with wound seroma	month	wound seroma, superficial wound breakdown (defined as skin and/or subcutaneous dehiscence with intact fascial layer).