Wound Infection in Obese Women After Cesarean Delivery
Surgical Site Infection in Obese Women After Cesarean Section; A Randomized Controlled Trial of Absorbable Versus Non Absorbable Sutures for Skin Closure.
1 other identifier
interventional
200
1 country
1
Brief Summary
The purpose of this study is to determine the surgical site infection rate and patient satisfaction for absorbable versus non absorbable suture in closure of skin at cesarean section in obese women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 3, 2012
CompletedFirst Posted
Study publicly available on registry
September 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedMay 24, 2013
May 1, 2013
9 months
September 3, 2012
May 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Surgical site infection
Diagnosis consists of infection of an anatomic plane by one of the following manifestations: collection; inflammatory signs (pain, tenderness, edema, redness); dehiscence(Wound separation was defined as any separation of the wound that was identified as such by the patient or the medical record and varied in size from small skin defects to separation of the entire wound; or positive culture.
Within 30 days of surgery
Secondary Outcomes (1)
Skin closure time
30 days
Other Outcomes (1)
Postoperative pain
7 Days
Study Arms (2)
Absorbable suture group
ACTIVE COMPARATORInclude women who have their skin closed with subcuticular stitches using \[Polyglactin 910 absorbable, synthetic, braided suture\].
Non absorbable suture group
ACTIVE COMPARATORInclude women who have their skin closed with subcuticular stitches using \[Polypropylene non absorbable monofilament suture\].
Interventions
Skin is closed with subcuticular stitches using \[Polyglactin 910 absorbable, synthetic, braided suture\]
Skin is closed with subcuticular stitches using Polypropylene non absorbable monofilament suture
Eligibility Criteria
You may qualify if:
- Pregnant female in child bearing period
- Mode of delivery is by cesarean section (CS)
- Obese women, Body Mass Index (BMI) \>30kg/m\^2
- Viable fetus
- Gestational age \>34 weeks
You may not qualify if:
- Hemoglobin (Hb)less than 10g/dl.
- Previous laparotomy other than CS.
- Rupture of membranes for more than 12 hours.
- Presence of signs of systemic or local infection on admission (e.g. fever, tender uterus).
- Prolonged operative time \>90 minutes.
- Previous two CS or more.
- Autoimmune disease.
- Immune suppressive disease.
- Corticosteroid medications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain shams university
Cairo, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gamal F. Mostafa, MD
Assistant Professor of Obstetrics & Gynecology Faculty of Medicine, Ain Shams University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Obstetrics & Gynecology
Study Record Dates
First Submitted
September 3, 2012
First Posted
September 6, 2012
Study Start
July 1, 2012
Primary Completion
April 1, 2013
Study Completion
May 1, 2013
Last Updated
May 24, 2013
Record last verified: 2013-05