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

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 Overview

• Status: Completed
• Conditions: Abdominal Delivery
• Intervention / Treatment: Other: closure of subcutaneous tissue; Other: No closure of subcutaneous tissue

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 Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Other: 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.
Other: No closure of subcutaneous tissue; in diabetic patients, the subcutaneous fat will not sutured after cesarean section.	Other: No closure of subcutaneous tissue; the subcutaneous fat will not sutured after cesarean section in diabetic patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with wound seroma	wound seroma, superficial wound breakdown (defined as skin and/or subcutaneous dehiscence with intact fascial layer).	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).	24 hours
Number of participants with postoperative fever	postoperative fever (defined as temperature more than thirty eight degree, 48 hours postoperative.	48 hours
Number of participants with cosmetic wound	Is cosmetic wound outcome for one month postoperative good or no?	1 month

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: January 20, 2016
• First Submitted That Met QC Criteria: January 22, 2016
• First Posted (Estimate): January 27, 2016

Study Record Updates

• Last Update Posted (Estimate): November 8, 2016
• Last Update Submitted That Met QC Criteria: November 6, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: ceserean section

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.