Surgical Site Infection (SSI)SUTURENCT07615517
Subcutaneous Suture Versus no Subcutaneous Suture for Abdominal Wound Closure
A study testing subcutaneous suture in people with Surgical Site Infection (SSI) and Wound Healing Complication, run by University Hospital Augsburg at 1 site in Germany.
Trial summary
Surgical site infections are among the most frequent complications after abdominal surgery and are associated with impaired wound healing, prolonged hospital stay, additional treatments, and increased healthcare costs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection (SSI), Wound Healing Complication
- What is being tested?
- subcutaneous suture
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 655 participants
- Where
- 1 siteGermany
- Study dates
- 23 Mar 2026to 30 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years)
- elective laparotomy (midline laparotomy, transverse laparotomy, subcostal incision, thoracoabdominal incision, or extended Pfannenstiel incision) or laparoscopically assisted abdominal surgery with a specimen extraction incision of at least 6 cm.
Who cannot join
- Emergency laparotomy.
- Anticipated or documented non-compliance with study procedures or follow-up.
- Patients in whom primary wound closure cannot be achieved at the end of surgery.
- Patients unable to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Augsburg
Augsburg, Bavaria
Florian Schepp, Dr. med., +490821400168803, florian.schepp@uk-augsburg.de
About this study
Official title: Subcutaneous Suture Versus no Subcutaneous Suture for Abdominal Wound Closure in Abdominal Surgery
Surgical site infections are among the most frequent complications after abdominal surgery and are associated with impaired wound healing, prolonged hospital stay, additional treatments, and increased healthcare costs. Closure of the subcutaneous tissue before skin closure is commonly performed in abdominal surgery, but the available evidence supporting this practice remains limited and heterogeneous, particularly outside caesarean section surgery.
The SUTURE trial is a prospective, randomized, patient- and assessor-blinded superiority trial evaluating whether subcutaneous tissue closure reduces the incidence of surgical site infections after abdominal surgery. Adult patients undergoing elective open or laparoscopically/robotically assisted abdominal surgery with an abdominal incision of at least 6 cm will be randomized intraoperatively after fascial closure to either subcutaneous tissue closure using interrupted Vicryl® 2-0 sutures or no subcutaneous tissue closure. The primary endpoint is the occurrence of surgical site infection according to CDC criteria grade I-II within 30 days after surgery.
The trial aims to provide high-quality evidence on whether routine subcutaneous tissue closure should be recommended as a standardized wound closure strategy in abdominal surgery.
Read the detailed description
Surgical site infections (SSI) remain a common and clinically relevant complication after abdominal surgery. They may lead to delayed wound healing, postoperative pain, prolonged hospital stay, additional outpatient or inpatient wound care, antibiotic therapy, reoperations, reduced patient satisfaction, and increased healthcare costs. Despite improvements in perioperative care, SSI prevention remains an important target in abdominal surgery.
One potentially modifiable factor is the technique of abdominal wall closure, particularly whether the subcutaneous tissue is closed before skin closure. Subcutaneous suturing is frequently used in clinical practice, especially in patients with thicker subcutaneous tissue layers. However, the available evidence regarding routine subcutaneous tissue closure in non-caesarean abdominal surgery remains limited and heterogeneous. Therefore, high-quality randomized data are needed to clarify whether subcutaneous tissue closure reduces postoperative SSI after abdominal surgery.
The SUTURE trial is a prospective, randomized, patient- and assessor-blinded, single-center superiority trial conducted at the University Hospital Augsburg. Adult patients scheduled for elective abdominal surgery with an abdominal incision of at least 6 cm are eligible for screening. This includes open abdominal surgery as well as laparoscopically or robotically assisted procedures requiring specimen extraction through an abdominal incision of at least 6 cm.
Randomization is performed intraoperatively after fascial closure and before skin closure. Patients are allocated in a 1:1 ratio to either subcutaneous tissue closure or no subcutaneous tissue closure. In the intervention group, the subcutaneous tissue is closed using interrupted Vicryl® 2-0 sutures. In the control group, no subcutaneous sutures are placed before skin closure. Skin closure is performed according to the standardized institutional approach, using skin staples for open laparotomy and continuous intracutaneous Monocryl® 3-0 sutures for laparoscopically or robotically assisted procedures.
Patients and postoperative outcome assessors are blinded to treatment allocation. The operating surgeon cannot be blinded due to the nature of the intervention. Postoperative wound assessments are performed during the inpatient stay and at the predefined 30-day follow-up visit. The primary endpoint is the occurrence of SSI according to CDC criteria grade I-II within 30 days after surgery.
Secondary endpoints include wound closure time, postoperative antibiotic therapy for SSI, wound healing disorders and their extent, wound dehiscence, reoperation related to wound complications, all SSI including CDC grade III, complete wound healing at follow-up, length of hospital stay, patient-reported scar assessment and quality of life, as well as wound-care-related healthcare resource utilization.
The aim of the trial is to determine whether routine subcutaneous tissue closure reduces the incidence of clinically relevant SSI after abdominal surgery and whether this technique should be recommended as a standardized component of abdominal wound closure.
- Being tested
- subcutaneous suture
- 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.
subcutaneous sutureProcedure or surgery
After standardized fascial closure according to institutional standards and subcutaneous irrigation with polyhexanide (Serasept®), patients are randomized to one of the following treatment groups:
Intervention group (subcutaneous suture group) Following fascial closure, the subcutaneous adipose tissue is approximated with interrupted absorbable sutures (Vicryl® 2-0).a
Skin closure is performed:
in open laparotomy using skin staples in laparoscopically assisted procedures using a continuous intracutaneous suture (Monocryl® 3-0)
| Study group | Role | What they receive |
|---|---|---|
| No subcutaneous suture | No intervention | After standardized fascial closure according to institutional standards, patients are randomized: Control group (no subcutaneous suture group) After fascial closure, no suturing of the subcutaneous tissue is performed. Skin closure is identical to the intervention group: in open laparotomy using skin staples in laparoscopically assisted procedures using a continuous intracutaneous suture (Monocryl® 3-0) |
| with subcutaneous suture | Experimental | After standardized fascial closure according to institutional standards, patients are randomized to one of the following treatment groups:
Intervention group (subcutaneous suture group) Following fascial closure, the subcutaneous adipose tissue is approximated with interrupted absorbable sutures (Vicryl® 2-0).a
Skin closure is performed:
in open laparotomy using skin staples in laparoscopically assisted procedures using a continuous intracutaneous suture (Monocryl® 3-0) Receives: Procedure: subcutaneous suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
SSI grade I or II according to CDC criteria within 30 days after surgery.
Occurrence of superficial or deep surgical site infection (SSI grade I or II according to CDC criteria) within 30 days after surgery, expressed as number and percentage of affected patients.
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start23 Mar 2026
- Primary completion1 Mar 2028 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site Infection (SSI)Studies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 655 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Augsburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johannes Lauscher, Prof. Dr. med., Principal investigator, Klinik für Allgemein-, Viszeral-, Transplantations- und Thoraxchirurgie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615517
- Sponsor's protocol ID
- 25-1085
- Other IDs
- DRKS00039310
- Acronym
- SUTURE
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available due to ethical, legal, and data protection restrictions. De-identified data may be made available from the principal investigator upon reasonable request and subject to institutional approval, if permitted by applicable regulations and participant consent.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Suture Versus no Subcutaneous Suture for Abdominal Wound Closure in Abdominal Surgery
- ClinicalTrials.gov ID
- NCT07615517
- Acronym / sponsor ID
- SUTURE / 25-1085
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 655 participants (estimated)
- Lead sponsor
- University Hospital AugsburgUniversity, hospital or other
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 29 May 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.
Surgical site infections are among the most frequent complications after abdominal surgery and are associated with impaired wound healing, prolonged hospital stay, additional treatments, and increased healthcare costs. Closure of the subcutaneous tissue before skin closure is commonly performed in abdominal surgery, but the available evidence supporting this practice remains limited and heterogeneous, particularly outside caesarean section surgery.
The SUTURE trial is a prospective, randomized, patient- and assessor-blinded superiority trial evaluating whether subcutaneous tissue closure reduces the incidence of surgical site infections after abdominal surgery. Adult patients undergoing elective open or laparoscopically/robotically assisted abdominal surgery with an abdominal incision of at least 6 cm will be randomized intraoperatively after fascial closure to either subcutaneous tissue closure using interrupted Vicryl® 2-0 sutures or no subcutaneous tissue closure. The primary endpoint is the occurrence of surgical site infection according to CDC criteria grade I-II within 30 days after surgery.
The trial aims to provide high-quality evidence on whether routine subcutaneous tissue closure should be recommended as a standardized wound closure strategy in abdominal surgery.
Detailed description
Surgical site infections (SSI) remain a common and clinically relevant complication after abdominal surgery. They may lead to delayed wound healing, postoperative pain, prolonged hospital stay, additional outpatient or inpatient wound care, antibiotic therapy, reoperations, reduced patient satisfaction, and increased healthcare costs. Despite improvements in perioperative care, SSI prevention remains an important target in abdominal surgery.
One potentially modifiable factor is the technique of abdominal wall closure, particularly whether the subcutaneous tissue is closed before skin closure. Subcutaneous suturing is frequently used in clinical practice, especially in patients with thicker subcutaneous tissue layers. However, the available evidence regarding routine subcutaneous tissue closure in non-caesarean abdominal surgery remains limited and heterogeneous. Therefore, high-quality randomized data are needed to clarify whether subcutaneous tissue closure reduces postoperative SSI after abdominal surgery.
The SUTURE trial is a prospective, randomized, patient- and assessor-blinded, single-center superiority trial conducted at the University Hospital Augsburg. Adult patients scheduled for elective abdominal surgery with an abdominal incision of at least 6 cm are eligible for screening. This includes open abdominal surgery as well as laparoscopically or robotically assisted procedures requiring specimen extraction through an abdominal incision of at least 6 cm.
Randomization is performed intraoperatively after fascial closure and before skin closure. Patients are allocated in a 1:1 ratio to either subcutaneous tissue closure or no subcutaneous tissue closure. In the intervention group, the subcutaneous tissue is closed using interrupted Vicryl® 2-0 sutures. In the control group, no subcutaneous sutures are placed before skin closure. Skin closure is performed according to the standardized institutional approach, using skin staples for open laparotomy and continuous intracutaneous Monocryl® 3-0 sutures for laparoscopically or robotically assisted procedures.
Patients and postoperative outcome assessors are blinded to treatment allocation. The operating surgeon cannot be blinded due to the nature of the intervention. Postoperative wound assessments are performed during the inpatient stay and at the predefined 30-day follow-up visit. The primary endpoint is the occurrence of SSI according to CDC criteria grade I-II within 30 days after surgery.
Secondary endpoints include wound closure time, postoperative antibiotic therapy for SSI, wound healing disorders and their extent, wound dehiscence, reoperation related to wound complications, all SSI including CDC grade III, complete wound healing at follow-up, length of hospital stay, patient-reported scar assessment and quality of life, as well as wound-care-related healthcare resource utilization.
The aim of the trial is to determine whether routine subcutaneous tissue closure reduces the incidence of clinically relevant SSI after abdominal surgery and whether this technique should be recommended as a standardized component of abdominal wound closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No subcutaneous suture | No intervention | –After standardized fascial closure according to institutional standards, patients are randomized: Control group (no subcutaneous suture group) After fascial closure, no suturing of the subcutaneous tissue is performed. Skin closure is identical to the intervention group: in open laparotomy using skin staples in laparoscopically assisted procedures using a continuous intracutaneous suture (Monocryl® 3-0) |
| with subcutaneous suture | Experimental | Procedure: subcutaneous sutureAfter standardized fascial closure according to institutional standards, patients are randomized to one of the following treatment groups: Intervention group (subcutaneous suture group) Following fascial closure, the subcutaneous adipose tissue is approximated with interrupted absorbable sutures (Vicryl® 2-0).a Skin closure is performed: in open laparotomy using skin staples in laparoscopically assisted procedures using a continuous intracutaneous suture (Monocryl® 3-0) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (≥18 years)
- elective laparotomy (midline laparotomy, transverse laparotomy, subcostal incision, thoracoabdominal incision, or extended Pfannenstiel incision) or laparoscopically assisted abdominal surgery with a specimen extraction incision of at least 6 cm.
Key exclusion criteria (4 listed)
- Emergency laparotomy.
- Anticipated or documented non-compliance with study procedures or follow-up.
- Patients in whom primary wound closure cannot be achieved at the end of surgery.
- Patients unable 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 |
|---|---|---|
| subcutaneous sutureAfter standardized fascial closure according to institutional standards and subcutaneous irrigation with polyhexanide (Serasept®), patients are randomized to one of the following treatment groups: Intervention group (subcutaneous suture group) Following fascial closure, the subcutaneous adipose tissue is approximated with interrupted absorbable sutures (Vicryl® 2-0).a Skin closure is performed: in open laparotomy using skin staples in laparoscopically assisted procedures using a continuous intracutaneous suture (Monocryl® 3-0) | Procedure or surgery | with subcutaneous suture |
Primary outcome
SSI grade I or II according to CDC criteria within 30 days after surgery.
Time frame: 30 days after surgery
Occurrence of superficial or deep surgical site infection (SSI grade I or II according to CDC criteria) within 30 days after surgery, expressed as number and percentage of affected patients.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available due to ethical, legal, and data protection restrictions. De-identified data may be made available from the principal investigator upon reasonable request and subject to institutional approval, if permitted by applicable regulations and participant consent.
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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.
Johannes Lauscher, Prof. Dr. med. principal investigator
Klinik für Allgemein-, Viszeral-, Transplantations- und Thoraxchirurgie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subcutaneous suture in people with Surgical Site Infection (SSI) and Wound Healing Complication, run by University Hospital Augsburg at 1 site in Germany.
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 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: looking for participants now, as of the sponsor's last update on 29 May 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florian Schepp, Dr. med. (+490821400168803, florian.schepp@uk-augsburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SSI grade I or II according to CDC criteria within 30 days after surgery. (time frame: 30 days after 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 29 May 2026.