Surgical Site InfectionNCT01679379
Wound Infection in Obese Women After Cesarean Delivery
A study testing Absorbable suture group and Non absorbable suture group in people with Surgical Site Infection, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Absorbable suture group and Non absorbable suture group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2012to May 2013
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- Autoimmune disease.
- Immune suppressive disease.
- Corticosteroid medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Site Infection in Obese Women After Cesarean Section; A Randomized Controlled Trial of Absorbable Versus Non Absorbable Sutures for Skin Closure.
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.
Read the detailed description
Cesarean section (CS) is the commonest major operation performed on women in the world. Approximately one in 4 women in the United States is delivered by cesarean section, and it is well established that operative abdominal delivery is associated with a significant risk of infection compared with vaginal delivery. These risks are increased with preexisting operative site infection, breaks in sterile technique, prolonged preoperative admissions that may result in colonization with resistant microbes, prolonged operative duration, use of electrocautery, obesity, advanced age, inadequate host immunocompetence.
Obese women may have increased susceptibility to infections because of the effects of obesity on the immune system, skin barriers, wound healing, mobility, and coexisting chronic diseases including diabetes, which could increase infection risk by itself. Cohort studies have shown that women with a body mass index (BMI)>30kg/m^2 have a two to three folds increased risk of post cesarean infections, such as wound infection, urinary tract infection UTI), endometritis, or pneumonia, compared with non-obese women. Other studies found that obesity doubled the risk specifically for post-cesarean wound infection.
Wound complications are a major source of morbidity after CS and contribute to prolonged hospital stay and rates of readmission. Age, (BMI), length of incision, and timing of prophylactic antibiotic administration have all been associated with post cesarean surgical site infection (SSI).
A surgical site infection is an infection that occurs after surgery in the part of the body where the surgery took place. SSI can sometimes be superficial infections involving the skin only. Other surgical site infections are more serious and can involve tissues under the skin, organs, or implanted material. SSI has a great impact on the economy and health care resources. Infection has always been a feature of modern surgery and continues to be a significant problem for health care practitioners across the world.
The ideal skin closure would be safe and effective, associated with minimal patient discomfort, and have a good cosmetic result. It would also be inexpensive and require fewer health care resources by being fast and easy to apply, require minimal follow-up evaluation, and be associated with a low rate of complications.
Methods for closing the skin at the time of cesarean delivery include stainless steel staples, subcuticular absorbable staples, subcuticular suture, adhesive closure strips, and tissue adhesives (cyanoacrylates). Each of the methods has its postulated benefits for wound outcomes; however, none of these have been compared in a prospective trial.
The role of skin closure suture material on wound complication rates in Obstetrics is poorly studied. And when we are talking about obese patients we did not find any recommendation regarding the suture material of skin closure although most of Obstetricians use different sutures materials.
Does closure of skin by absorbable compared to non absorbable suture affect the rate of surgical site infection in obese patients undergoing caesarian section? Our hypothesis is that no difference between absorbable compared to non absorbable suture.
- Conditions
- Surgical Site Infection
- Being tested
- Absorbable suture group, Non absorbable suture group
- Keywords
- Cesarean Section, Obese Women, Surgical Site Infection
- 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.
Absorbable suture groupProcedure or surgery
Skin is closed with subcuticular stitches using [Polyglactin 910 absorbable, synthetic, braided suture]
Non absorbable suture groupProcedure or surgery
Skin is closed with subcuticular stitches using Polypropylene non absorbable monofilament suture
| Study group | Role | What they receive |
|---|---|---|
| Absorbable suture group | Active comparator | Include women who have their skin closed with subcuticular stitches using [Polyglactin 910 absorbable, synthetic, braided suture]. Receives: Procedure: Absorbable suture group |
| Non absorbable suture group | Active comparator | Include women who have their skin closed with subcuticular stitches using [Polypropylene non absorbable monofilament suture]. Receives: Procedure: Non absorbable suture group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 30 days of surgery
Secondary outcomes (1)
Skin closure time
Complete wound closure
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 posted6 Sep 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 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
- Gamal F. Mostafa, MD, Study director, Assistant Professor of Obstetrics & Gynecology Faculty of Medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679379
- Sponsor's protocol ID
- ASU-07-2012
- Status last verified
- May 2013
- First submitted
- 3 Sep 2012
- Last updated
- 24 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Site Infection in Obese Women After Cesarean Section; A Randomized Controlled Trial of Absorbable Versus Non Absorbable Sutures for Skin Closure.
- ClinicalTrials.gov ID
- NCT01679379
- Acronym / sponsor ID
- ASU-07-2012
- Conditions
- Surgical Site Infection
- Keywords
- Cesarean Section, Obese Women, Surgical Site Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 6 Sep 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 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.
Detailed description
Cesarean section (CS) is the commonest major operation performed on women in the world. Approximately one in 4 women in the United States is delivered by cesarean section, and it is well established that operative abdominal delivery is associated with a significant risk of infection compared with vaginal delivery. These risks are increased with preexisting operative site infection, breaks in sterile technique, prolonged preoperative admissions that may result in colonization with resistant microbes, prolonged operative duration, use of electrocautery, obesity, advanced age, inadequate host immunocompetence.
Obese women may have increased susceptibility to infections because of the effects of obesity on the immune system, skin barriers, wound healing, mobility, and coexisting chronic diseases including diabetes, which could increase infection risk by itself. Cohort studies have shown that women with a body mass index (BMI)>30kg/m^2 have a two to three folds increased risk of post cesarean infections, such as wound infection, urinary tract infection UTI), endometritis, or pneumonia, compared with non-obese women. Other studies found that obesity doubled the risk specifically for post-cesarean wound infection.
Wound complications are a major source of morbidity after CS and contribute to prolonged hospital stay and rates of readmission. Age, (BMI), length of incision, and timing of prophylactic antibiotic administration have all been associated with post cesarean surgical site infection (SSI).
A surgical site infection is an infection that occurs after surgery in the part of the body where the surgery took place. SSI can sometimes be superficial infections involving the skin only. Other surgical site infections are more serious and can involve tissues under the skin, organs, or implanted material. SSI has a great impact on the economy and health care resources. Infection has always been a feature of modern surgery and continues to be a significant problem for health care practitioners across the world.
The ideal skin closure would be safe and effective, associated with minimal patient discomfort, and have a good cosmetic result. It would also be inexpensive and require fewer health care resources by being fast and easy to apply, require minimal follow-up evaluation, and be associated with a low rate of complications.
Methods for closing the skin at the time of cesarean delivery include stainless steel staples, subcuticular absorbable staples, subcuticular suture, adhesive closure strips, and tissue adhesives (cyanoacrylates). Each of the methods has its postulated benefits for wound outcomes; however, none of these have been compared in a prospective trial.
The role of skin closure suture material on wound complication rates in Obstetrics is poorly studied. And when we are talking about obese patients we did not find any recommendation regarding the suture material of skin closure although most of Obstetricians use different sutures materials.
Does closure of skin by absorbable compared to non absorbable suture affect the rate of surgical site infection in obese patients undergoing caesarian section? Our hypothesis is that no difference between absorbable compared to non absorbable suture.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absorbable suture group | Active comparator | Procedure: Absorbable suture groupInclude women who have their skin closed with subcuticular stitches using [Polyglactin 910 absorbable, synthetic, braided suture]. |
| Non absorbable suture group | Active comparator | Procedure: Non absorbable suture groupInclude women who have their skin closed with subcuticular stitches using [Polypropylene non absorbable monofilament suture]. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Absorbable suture groupSkin is closed with subcuticular stitches using [Polyglactin 910 absorbable, synthetic, braided suture] | Procedure or surgery | Absorbable suture group |
| Non absorbable suture groupSkin is closed with subcuticular stitches using Polypropylene non absorbable monofilament suture | Procedure or surgery | Non absorbable suture group |
Primary outcome
Surgical site infection
Time frame: Within 30 days of surgery
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.
1 secondary outcome
Skin closure time
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 24 May 2013.
Related trials for Surgical Site Infection
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
RecruitingObservational study
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Surgical Site Infection
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
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.
Gamal F. Mostafa, MD study director
Assistant Professor of Obstetrics & Gynecology Faculty of Medicine, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Absorbable suture group and Non absorbable suture group in people with Surgical Site Infection, run by Ain Shams University at 1 site in Egypt.
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 5 inclusion and 9 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 24 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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: Within 30 days of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2013.