Cesarean Section; InfectionNCT03536832
Subcuticular Skin Closure at Cesarean Delivery
A study testing Cesarean Section with Vicryl and Cesarean Section with Prolen in people with Cesarean Section; Infection, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Subcuticular skin closure with suture after cesarean has been shown to result in lower rates of wound complications than with staple closure. However, the optimal choice of suture material for subcuticular skin closure is unclear. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section; Infection
- What is being tested?
- Cesarean Section with Vicryl and Cesarean Section with Prolen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2018to 1 Nov 2018
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-40
- women undergoing cesarean section
Who cannot join
- body mass index>30
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Suture Materials for Subcuticular Skin Closure at Cesarean Delivery
Subcuticular skin closure with suture after cesarean has been shown to result in lower rates of wound complications than with staple closure. However, the optimal choice of suture material for subcuticular skin closure is unclear. Vicryl vs Prolen suture materials will be used for subcuticular closure of transverse skin incisions after cesarean section. Patients will be controlled for superficial surgical site infections 1 week after the cesarean section.
Read the detailed description
Cesarean section is the most common abdominal surgery worldwide. Subcuticular skin closure with suture after cesarean has been shown to result in lower rates of wound complications than with staple closure. However, the optimal choice of suture material for subcuticular skin closure is unclear. Vicryl vs Prolen suture materials will be used for subcuticular closure of transverse skin incisions after cesarean section. Patients will be controlled for superficial surgical site infections 1 week after the cesarean section.
- Conditions
- Cesarean Section; Infection
- Being tested
- Cesarean Section with Vicryl, Cesarean Section with Prolen
- Keywords
- Cesarean Section; Complications, suture material
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cesarean Section with VicrylProcedure or surgery
Pfnannenstiel incision will be done under general or spinal anaesthesia. The abdomen will be opened and fetus and plasenta will be delivered. Then abdomen will be closed. Skin will be closed with Vicryl.
Cesarean Section with ProlenProcedure or surgery
Pfnannenstiel incision will be done under general or spinal anaesthesia. The abdomen will be opened and fetus and plasenta will be delivered. Then abdomen will be closed. Skin will be closed with prolen.
| Study group | Role | What they receive |
|---|---|---|
| cesarean section with Vicryl | Active comparator | Women undergoing cesarean section with low transverse skin incisions will be closed with 3-0 Vicryl. Receives: Procedure: Cesarean Section with Vicryl |
| cesarean section with prolene | Active comparator | Women undergoing cesarean section with low transverse skin incisions will be closed with 3-0 Prolen. Receives: Procedure: Cesarean Section with Prolen |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical site infection
infection
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start15 Apr 2018
- Primary completion15 Oct 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section; InfectionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Berna Aslan A Çetin, Principal investigator, KSSTRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536832
- Sponsor's protocol ID
- 2018.4.20
- Status last verified
- Oct 2018
- First submitted
- 9 May 2018
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Suture Materials for Subcuticular Skin Closure at Cesarean Delivery
- ClinicalTrials.gov ID
- NCT03536832
- Acronym / sponsor ID
- 2018.4.20
- Conditions
- Cesarean Section; Infection
- Keywords
- Cesarean Section; Complications, suture material
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 25 May 2018 (actual)
- 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.
Subcuticular skin closure with suture after cesarean has been shown to result in lower rates of wound complications than with staple closure. However, the optimal choice of suture material for subcuticular skin closure is unclear. Vicryl vs Prolen suture materials will be used for subcuticular closure of transverse skin incisions after cesarean section. Patients will be controlled for superficial surgical site infections 1 week after the cesarean section.
Detailed description
Cesarean section is the most common abdominal surgery worldwide. Subcuticular skin closure with suture after cesarean has been shown to result in lower rates of wound complications than with staple closure. However, the optimal choice of suture material for subcuticular skin closure is unclear. Vicryl vs Prolen suture materials will be used for subcuticular closure of transverse skin incisions after cesarean section. Patients will be controlled for superficial surgical site infections 1 week after the cesarean section.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cesarean section with Vicryl | Active comparator | Procedure: Cesarean Section with VicrylWomen undergoing cesarean section with low transverse skin incisions will be closed with 3-0 Vicryl. |
| cesarean section with prolene | Active comparator | Procedure: Cesarean Section with ProlenWomen undergoing cesarean section with low transverse skin incisions will be closed with 3-0 Prolen. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-40
- women undergoing cesarean section
Key exclusion criteria (1 listed)
- body mass index>30
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 |
|---|---|---|
| Cesarean Section with VicrylPfnannenstiel incision will be done under general or spinal anaesthesia. The abdomen will be opened and fetus and plasenta will be delivered. Then abdomen will be closed. Skin will be closed with Vicryl. | Procedure or surgery | cesarean section with Vicryl |
| Cesarean Section with ProlenPfnannenstiel incision will be done under general or spinal anaesthesia. The abdomen will be opened and fetus and plasenta will be delivered. Then abdomen will be closed. Skin will be closed with prolen. | Procedure or surgery | cesarean section with prolene |
Primary outcome
surgical site infection
Time frame: 1 week
infection
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 16 Nov 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Cesarean Section; Infection
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
RecruitingPhase 1
Restoration of the Gut Microbiome After Cesarean Section
Microbial Colonization
Not yet recruitingObservational study
Timing of Cesarean Wound Dressing Removal on Wound Healing in Women With BMI ≥ 30 kg/m²
Cesarean Section, Surgical Wound Infection
Enrolling by invitation
A Randomized Controlled Trial Comparing the Incidence of Surgical Site Infections in Cesarean Section With and Without Subcutaneous Drain Placement at Queen Savang Vadhana Memorial Hospital
Surgical Site Infection (SSI)
Not yet recruiting
Intraperitoneal Saline Irrigation in Cesarean Section
Cesarean Section
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.
Berna Aslan A Çetin principal investigator
KSSTRH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cesarean Section with Vicryl and Cesarean Section with Prolen in people with Cesarean Section; Infection, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 1 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 16 Nov 2018. 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 Turkey (Türkiye). 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: 1 week). 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 16 Nov 2018.