Post Operative Wound InfectionNCT07451275
No Closure vs Interrupted vs Continuous Subcutaneous Closure: Operative Time and Wound Outcomes
A study testing Suture technique, Interrupted closure (3 sutures) and Suture technique, Continuous non-locking closure in people with Post Operative Wound Infection and Suture, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to research whether different methods of suturing during elective cesarean delivery affect surgery time and early wound healing. The study includes adults undergoing elective cesarean delivery with subcutaneous fat thickness of at least 2 centimetres. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post Operative Wound Infection, Suture, Suture Techniques
- What is being tested?
- Suture technique, Interrupted closure (3 sutures) and Suture technique, Continuous non-locking closure
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2022to 20 Oct 2022
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Scheduled for elective cesarean delivery via Pfannenstiel incision at the study site
- Subcutaneous adipose tissue thickness 2 cm or greater (measured intraoperatively/at time of surgery per protocol)
- Able and willing to provide written informed consent
- Willing to return for postoperative day 10 follow-up assessment (clinical exam and incision-site ultrasonography)
Who cannot join
- Any condition associated with impaired wound healing (e.g., diabetes mellitus, autoimmune disease)
- Current systemic corticosteroid use
- Suspected or confirmed infection at the time of delivery, including chorioamnionitis
- Premature rupture of membranes
- Refusal or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of No Subcutaneous Closure, Interrupted Closure, and Continuous Non-locking Closure at Elective Cesarean Delivery
The goal of this clinical trial is to research whether different methods of suturing during elective cesarean delivery affect surgery time and early wound healing. The study includes adults undergoing elective cesarean delivery with subcutaneous fat thickness of at least 2 centimetres.
The main questions it aims to answer are:
Read more
- Does the closure method change how long the surgery takes?
- Does the closure method change the chance of wound problems by day ten after surgery (such as fluid collection under the skin or wound infection)?
The investigators will compare three approaches-no subcutaneous suturing, three interrupted sutures, and one continuous non-locking suture-to research if one method improves wound outcomes without meaningfully increasing operative time.
Participants will:
Receive one of the three closure methods during their cesarean delivery Return around day ten after surgery for a standardised wound examination and an ultrasound evaluation of the incision area.
Read the detailed description
Postoperative wound morbidity after cesarean delivery, while relatively infrequent, contributes to maternal discomfort, delayed recovery, and increased health care utilization. Subcutaneous tissue management at closure is a potentially modifiable surgical step, and both the decision to approximate the subcutaneous layer and the suturing technique may influence early wound outcomes as well as operative efficiency. However, consensus is lacking regarding the optimal approach.
This prospective comparative study evaluates three standardized subcutaneous tissue closure strategies among adults undergoing elective cesarean delivery via Pfannenstiel incision with a subcutaneous adipose tissue thickness of at least two centimeters: (one) no subcutaneous suturing, (two) closure with three interrupted sutures, and (three) closure with a continuous non-locking single-layer suture. Participants are assigned in equal numbers to each strategy using a predefined sequential allocation based on operative order. The surgical technique and follow-up assessments are conducted according to a predefined protocol, and participants are blinded to group assignment.
The study focuses on two clinically relevant domains: operative duration and short-term wound outcomes. Operative efficiency is assessed using total surgery duration. Wound outcomes are assessed around postoperative day ten using both standardized clinical incision assessment (including signs suggestive of infection such as erythema, warmth, discharge, dehiscence, or separation) and incision-site ultrasonography to identify subcutaneous fluid collection and other wound-related findings. By comparing these commonly used closure strategies under standardized conditions, the study aims to determine whether subcutaneous closure technique meaningfully affects operative time and early wound morbidity following elective cesarean delivery.
- Being tested
- Suture technique, Interrupted closure (3 sutures), Suture technique, Continuous non-locking closure
- Keywords
- Cesarean Delivery, Subcutaneous Tissue Closure, Subcutaneous Suturing, Interrupted Suture, Continuous Non-locking Suture, Surgical Site Infection, Subcutaneous Fluid Collection
- 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.
Suture technique, Interrupted closure (3 sutures)Other
Interrupted closure (3 sutures):
Subcutaneous adipose tissue is sutured with three interrupted sutures placed along the incision before routine skin closure.
Suture technique, Continuous non-locking closureOther
Continuous non-locking closure:
Subcutaneous adipose tissue is approximated with a single-layer continuous, non-locking running suture along the incision before routine skin closure.
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous Closure (No Suturing) | No intervention | Participants undergo elective cesarean delivery with no subcutaneous closure prior to skin closure. |
| Interrupted Subcutaneous Closure (Three Interrupted Sutures) | Experimental | Participants undergo elective cesarean delivery with subcutaneous suturing using three interrupted sutures before skin closure. Receives: Other: Suture technique, Interrupted closure (3 sutures) |
| Continuous Non-locking Subcutaneous Closure (Single-layer Continuous Suture) | Experimental | Participants undergo elective cesarean delivery with single-layer subcutaneous tissue suturing using a continuous, non-locking suture technique prior to skin closure Receives: Other: Suture technique, Continuous non-locking closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall wound complications by postoperative day 10
Proportion of participants with any wound complication at day 10, defined as any abnormal incision-site ultrasonography finding (e.g., subcutaneous fluid collection/seroma, hematoma, abscess, cavity formation) and/or clinical wound infection findings on standardized exam (e.g., discharge, dehiscence, erythema, warmth). Outcome is recorded as present vs absent.
Measured: Postoperative day 10
Secondary outcomes (1)
Operative duration
Total surgery duration recorded in minutes (operative time).
Measured: Day of surgery (intraoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start30 Mar 2022
- Primary completion20 Oct 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post Operative Wound 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Metin Ayğar, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451275
- Sponsor's protocol ID
- YuzuncuYılUniversity_CS_Suture
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data will be shared with qualified researchers upon reasonable request after publication of the primary results, subject to approval by the study team and completion of a data use agreement, to protect participant confidentiality.
Publications
Carbonnel M, Brot D, Benedetti C, Kennel T, Murtada R, Revaux A, Ayoubi JM. Risks factors FOR wound complications after cesarean section. J Gynecol Obstet Hum Reprod. 2021 Sep;50(7):101987. doi: 10.1016/j.jogoh.2020.101987. Epub 2020 Nov 16.
PubMed 33212324Pergialiotis V, Prodromidou A, Perrea DN, Doumouchtsis SK. The impact of subcutaneous tissue suturing at caesarean section on wound complications: a meta-analysis. BJOG. 2017 Jun;124(7):1018-1025. doi: 10.1111/1471-0528.14593. Epub 2017 Apr 1.
PubMed 28176441
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of No Subcutaneous Closure, Interrupted Closure, and Continuous Non-locking Closure at Elective Cesarean Delivery
- ClinicalTrials.gov ID
- NCT07451275
- Acronym / sponsor ID
- YuzuncuYılUniversity_CS_Suture
- Keywords
- Cesarean Delivery, Subcutaneous Tissue Closure, Subcutaneous Suturing, Interrupted Suture, Continuous Non-locking Suture, Surgical Site Infection, Subcutaneous Fluid Collection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 5 Mar 2026 (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.
The goal of this clinical trial is to research whether different methods of suturing during elective cesarean delivery affect surgery time and early wound healing. The study includes adults undergoing elective cesarean delivery with subcutaneous fat thickness of at least 2 centimetres.
The main questions it aims to answer are:
- Does the closure method change how long the surgery takes?
- Does the closure method change the chance of wound problems by day ten after surgery (such as fluid collection under the skin or wound infection)?
The investigators will compare three approaches-no subcutaneous suturing, three interrupted sutures, and one continuous non-locking suture-to research if one method improves wound outcomes without meaningfully increasing operative time.
Participants will:
Receive one of the three closure methods during their cesarean delivery Return around day ten after surgery for a standardised wound examination and an ultrasound evaluation of the incision area.
Detailed description
Postoperative wound morbidity after cesarean delivery, while relatively infrequent, contributes to maternal discomfort, delayed recovery, and increased health care utilization. Subcutaneous tissue management at closure is a potentially modifiable surgical step, and both the decision to approximate the subcutaneous layer and the suturing technique may influence early wound outcomes as well as operative efficiency. However, consensus is lacking regarding the optimal approach.
This prospective comparative study evaluates three standardized subcutaneous tissue closure strategies among adults undergoing elective cesarean delivery via Pfannenstiel incision with a subcutaneous adipose tissue thickness of at least two centimeters: (one) no subcutaneous suturing, (two) closure with three interrupted sutures, and (three) closure with a continuous non-locking single-layer suture. Participants are assigned in equal numbers to each strategy using a predefined sequential allocation based on operative order. The surgical technique and follow-up assessments are conducted according to a predefined protocol, and participants are blinded to group assignment.
The study focuses on two clinically relevant domains: operative duration and short-term wound outcomes. Operative efficiency is assessed using total surgery duration. Wound outcomes are assessed around postoperative day ten using both standardized clinical incision assessment (including signs suggestive of infection such as erythema, warmth, discharge, dehiscence, or separation) and incision-site ultrasonography to identify subcutaneous fluid collection and other wound-related findings. By comparing these commonly used closure strategies under standardized conditions, the study aims to determine whether subcutaneous closure technique meaningfully affects operative time and early wound morbidity following elective cesarean delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous Closure (No Suturing) | No intervention | –Participants undergo elective cesarean delivery with no subcutaneous closure prior to skin closure. |
| Interrupted Subcutaneous Closure (Three Interrupted Sutures) | Experimental | Other: Suture technique, Interrupted closure (3 sutures)Participants undergo elective cesarean delivery with subcutaneous suturing using three interrupted sutures before skin closure. |
| Continuous Non-locking Subcutaneous Closure (Single-layer Continuous Suture) | Experimental | Other: Suture technique, Continuous non-locking closureParticipants undergo elective cesarean delivery with single-layer subcutaneous tissue suturing using a continuous, non-locking suture technique prior to skin closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- Scheduled for elective cesarean delivery via Pfannenstiel incision at the study site
- Subcutaneous adipose tissue thickness 2 cm or greater (measured intraoperatively/at time of surgery per protocol)
- Able and willing to provide written informed consent
- Willing to return for postoperative day 10 follow-up assessment (clinical exam and incision-site ultrasonography)
Key exclusion criteria (5 listed)
- Any condition associated with impaired wound healing (e.g., diabetes mellitus, autoimmune disease)
- Current systemic corticosteroid use
- Suspected or confirmed infection at the time of delivery, including chorioamnionitis
- Premature rupture of membranes
- Refusal or inability to provide informed consent
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 |
|---|---|---|
| Suture technique, Interrupted closure (3 sutures)Interrupted closure (3 sutures): Subcutaneous adipose tissue is sutured with three interrupted sutures placed along the incision before routine skin closure. | Other | Interrupted Subcutaneous Closure (Three Interrupted Sutures) |
| Suture technique, Continuous non-locking closureContinuous non-locking closure: Subcutaneous adipose tissue is approximated with a single-layer continuous, non-locking running suture along the incision before routine skin closure. | Other | Continuous Non-locking Subcutaneous Closure (Single-layer Continuous Suture) |
Primary outcome
Overall wound complications by postoperative day 10
Time frame: Postoperative day 10
Proportion of participants with any wound complication at day 10, defined as any abnormal incision-site ultrasonography finding (e.g., subcutaneous fluid collection/seroma, hematoma, abscess, cavity formation) and/or clinical wound infection findings on standardized exam (e.g., discharge, dehiscence, erythema, warmth). Outcome is recorded as present vs absent.
1 secondary outcome
Operative duration
Time frame: Day of surgery (intraoperative)
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 6 Mar 2026.
- Background: PubMed 33212324Carbonnel M, Brot D, Benedetti C, Kennel T, Murtada R, Revaux A, Ayoubi JM. Risks factors FOR wound complications after cesarean section. J Gynecol Obstet Hum Reprod. 2021 Sep;50(7):101987. doi: 10.1016/j.jogoh.2020.101987. Epub 2020 Nov 16.
- Background: PubMed 28176441Pergialiotis V, Prodromidou A, Perrea DN, Doumouchtsis SK. The impact of subcutaneous tissue suturing at caesarean section on wound complications: a meta-analysis. BJOG. 2017 Jun;124(7):1018-1025. doi: 10.1111/1471-0528.14593. Epub 2017 Apr 1.
- Individual participant dataSharing planned: No. De-identified individual participant data will be shared with qualified researchers upon reasonable request after publication of the primary results, subject to approval by the study team and completion of a data use agreement, to protect participant confidentiality.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suture technique, Interrupted closure (3 sutures) and Suture technique, Continuous non-locking closure in people with Post Operative Wound Infection and Suture, run by Yuzuncu Yil University 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 5 inclusion and 5 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 6 Mar 2026. 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?
Overall wound complications by postoperative day 10 (time frame: Postoperative day 10). 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 NCT07451275, which also lists 2 linked publications.
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 6 Mar 2026.