Surgical Site InfectionNCT01713751
Surgical Site Infection Rates in Obese Patients After Cesarean Delivery
A study testing Interrupted suturing and Subcuticular suturing in people with Surgical Site Infection, run by Ain Shams University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Interrupted suturing and Subcuticular suturing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age: any female in childbearing period.
- Women planned for elective Cesarean section.
- Obese women (BMI ≥ 30 Kg/m2). Our study calculated the BMI of patients from their weight and height at admission, because the pre-pregnancy BMI was not available for all patients, and we hypothesized that the BMI at admission was a better indicator of body mass during the at-risk time for development of SSI than was the pre-pregnancy BMI.
Who cannot join
- Women who had concurrent overt infection (e.g.chorioamnionitis, pyelonephritis or chest infection).
- Women who had intraoperative events that may themselves predispose to perioperative infection (e.g. bowel injury, operative time more than 90 minutes, major blood loss).
- Women who had hemoglobin less than 10g/dl, preeclampsia, diabetes, rupture of membranes more than 12 hours, corticosteroid therapy.
- Patients who had non Pfannenstiel incision.
About this study
Official title: Surgical Site Infection Rates of Two Different Skin Closure Methods Used in Obese Patients After Cesarean Delivery
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.
Read the detailed description
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.
- Conditions
- Surgical Site Infection
- Being tested
- Interrupted suturing, Subcuticular suturing
- Keywords
- Surgical site infection, Cesarean section
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interrupted suturingOther
Skin is closed with interrupted mattress stitches using non-absorbable polypropylene [Prolene®]
Subcuticular suturingOther
Skin is closed with subcuticular stitches using non-absorbable polypropylene [Prolene®]
| Study group | Role | What they receive |
|---|---|---|
| Interrupted suturing Group | Active comparator | Includes women who have their skin closed with interrupted mattress stitches using non-absorbable polypropylene [Prolene®] Receives: Other: Interrupted suturing |
| Subcuticular suturing Group | Active comparator | Includes women who have their skin closed with subcuticular stitches using non-absorbable polypropylene [Prolene®]. Receives: Other: Subcuticular suturing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
We used the definition devised and adopted by the Center for Disease Control and Prevention.
Measured: 30 days after the operative procedure
Secondary outcomes (4)
Skin closure time
Measured: 15 minutes
Postoperative pain
Measured by 10-cm visual analogue scale, zero being no pain and ten the worst possible pain
Measured: 48 hours
Short-term cosmetic wound outcome
We used Stony Brook Scar Evaluation Scale
Measured: 30 days
Overall women satisfaction
A questionnaire is used to check the patient satisfaction (satisfied versus unsatisfied) regarding the wound appearance and wound related pain
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ellaithy, Ain Shams University
- Investigators
- Moustafa I. Ibrahim, MD, Study director, Assistant Professor of Obstetrics & Gynecology Faculty of Medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713751
- Sponsor's protocol ID
- ASUOGRCT03-2012
- Status last verified
- Oct 2012
- First submitted
- 14 Oct 2012
- Last updated
- 25 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ibrahim MI, Moustafa GF, Al-Hamid AS, Hussein MR. Superficial incisional surgical site infection rate after cesarean section in obese women: a randomized controlled trial of subcuticular versus interrupted skin suturing. Arch Gynecol Obstet. 2014 May;289(5):981-6. doi: 10.1007/s00404-013-3098-z. Epub 2013 Nov 24.
PubMed 24272023
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Site Infection Rates of Two Different Skin Closure Methods Used in Obese Patients After Cesarean Delivery
- ClinicalTrials.gov ID
- NCT01713751
- Acronym / sponsor ID
- ASUOGRCT03-2012
- Conditions
- Surgical Site Infection
- Keywords
- Surgical site infection, Cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 25 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interrupted suturing Group | Active comparator | Other: Interrupted suturingIncludes women who have their skin closed with interrupted mattress stitches using non-absorbable polypropylene [Prolene®] |
| Subcuticular suturing Group | Active comparator | Other: Subcuticular suturingIncludes women who have their skin closed with subcuticular stitches using non-absorbable polypropylene [Prolene®]. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: any female in childbearing period.
- Women planned for elective Cesarean section.
- Obese women (BMI ≥ 30 Kg/m2). Our study calculated the BMI of patients from their weight and height at admission, because the pre-pregnancy BMI was not available for all patients, and we hypothesized that the BMI at admission was a better indicator of body mass during the at-risk time for development of SSI than was the pre-pregnancy BMI.
Key exclusion criteria (4 listed)
- Women who had concurrent overt infection (e.g.chorioamnionitis, pyelonephritis or chest infection).
- Women who had intraoperative events that may themselves predispose to perioperative infection (e.g. bowel injury, operative time more than 90 minutes, major blood loss).
- Women who had hemoglobin less than 10g/dl, preeclampsia, diabetes, rupture of membranes more than 12 hours, corticosteroid therapy.
- Patients who had non Pfannenstiel incision.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interrupted suturingSkin is closed with interrupted mattress stitches using non-absorbable polypropylene [Prolene®] | Other | Interrupted suturing Group |
| Subcuticular suturingSkin is closed with subcuticular stitches using non-absorbable polypropylene [Prolene®] | Other | Subcuticular suturing Group |
Primary outcome
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.
4 secondary outcomes
Skin closure time
Time frame: 15 minutes
Postoperative pain
Time frame: 48 hours
Short-term cosmetic wound outcome
Time frame: 30 days
Overall women satisfaction
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2012.
- Derived from this study: PubMed 24272023Ibrahim MI, Moustafa GF, Al-Hamid AS, Hussein MR. Superficial incisional surgical site infection rate after cesarean section in obese women: a randomized controlled trial of subcuticular versus interrupted skin suturing. Arch Gynecol Obstet. 2014 May;289(5):981-6. doi: 10.1007/s00404-013-3098-z. Epub 2013 Nov 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moustafa I. Ibrahim, MD study director
Assistant Professor of Obstetrics & Gynecology Faculty of Medicine, Ain Shams University
Questions about this trial
What is this clinical trial studying?
A study testing Interrupted suturing and Subcuticular suturing in people with Surgical Site Infection, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical site infection (time frame: 30 days after the operative procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01713751, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2012.