Surgical Site Infection Rates in Obese Patients After Cesarean Delivery
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|ClinicalTrials.gov Identifier: NCT01713751|
Recruitment Status : Completed
First Posted : October 25, 2012
Last Update Posted : October 25, 2012
|Condition or disease||Intervention/treatment||Phase|
|Surgical Site Infection||Other: Interrupted suturing Other: Subcuticular suturing||Not Applicable|
This is a randomized controlled trial conducted in Ain-Shams University Maternity Hospital on the period from March 2012 till August 2012. It included 130 pregnant women who underwent elective Cesarean section.
The aim of this study is to determine the surgical site infection rate and patient satisfaction for subcuticular versus interrupted mattress suture in closure of skin at Cesarean delivery in obese patients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Surgical Site Infection Rates of Two Different Skin Closure Methods Used in Obese Patients After Cesarean Delivery|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||September 2012|
Active Comparator: Interrupted suturing Group
Includes women who have their skin closed with interrupted mattress stitches using non-absorbable polypropylene [Prolene®]
Other: Interrupted suturing
Skin is closed with interrupted mattress stitches using non-absorbable polypropylene [Prolene®]
Active Comparator: Subcuticular suturing Group
Includes women who have their skin closed with subcuticular stitches using non-absorbable polypropylene [Prolene®].
Other: Subcuticular suturing
Skin is closed with subcuticular stitches using non-absorbable polypropylene [Prolene®]
- Surgical site infection [ Time Frame: 30 days after the operative procedure ]We used the definition devised and adopted by the Center for Disease Control and Prevention.
- Skin closure time [ Time Frame: 15 minutes ]
- Postoperative pain [ Time Frame: 48 hours ]Measured by 10-cm visual analogue scale, zero being no pain and ten the worst possible pain
- Short-term cosmetic wound outcome [ Time Frame: 30 days ]We used Stony Brook Scar Evaluation Scale
- Overall women satisfaction [ Time Frame: 30 days ]A questionnaire is used to check the patient satisfaction (satisfied versus unsatisfied) regarding the wound appearance and wound related pain
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01713751
|Study Director:||Moustafa I. Ibrahim, MD||Assistant Professor of Obstetrics & Gynecology Faculty of Medicine, Ain Shams University|