Overview

This trial has been completed.

Condition abdominal delivery
Treatments closure of subcutaneous tissue, no closure of subcutaneous tissue
Sponsor Ain Shams University
Start date January 2016
End date September 2016
Trial size 136 participants
Trial identifier NCT02664285, ceserean section

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose prevention
Arm
(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.
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)
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.

Primary Outcomes

Measure
Number of participants with surgical site infection
time frame: 9 months

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants from 18 years up to 45 years old.

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.

Additional Information

Official title Closure Versus Non Closure of Subcutaneous Tissue After Cesarean Section in Diabetic Patients
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Ain Shams University.