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

NCT02664285 | Completed DMC

• 1 other identifier: ceserean section
• Study Type: interventional
• Target: 136
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Abdominal Delivery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of participants with wound seroma

  month

• Number of participants with postoperative pain

  24 hours

• Number of participants with postoperative fever

  48 hours

• Number of participants with cosmetic wound

  1 month

Study Arms (2)

closure of subcutaneous tissue

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.

Other: closure of subcutaneous tissue

No closure of subcutaneous tissue

OTHER

in diabetic patients, the subcutaneous fat will not sutured after cesarean section.

Other: No closure of subcutaneous tissue

Interventions

closure of subcutaneous tissue OTHER

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.

closure of subcutaneous tissue

No closure of subcutaneous tissue OTHER

the subcutaneous fat will not sutured after cesarean section in diabetic patients.

No closure of subcutaneous tissue

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Hemoglobin less than 10g/dl.
• Intra operative events that may themselves predispose to postoperative infection (e.g. operative time more than 90 minutes).
• Rupture of membrane more than 12 hours.
• Receive corticosteroid medications.
• Immunosuppressive disease or Auto immune disease.
• Concurrent infection (e.g. signs of pyelonephritis, chest infection).
• Previous history of two C.S.
• Previous laparotomy other than C.S.

Sponsors & Collaborators

• Ain Shams University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynaecology Faculty of Medicine, Ain Shams University

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: January 27, 2016
• Study Start: January 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 8, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share