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Recruiting NCT07615517

Subcutaneous Suture Versus no Subcutaneous Suture for Abdominal Wound Closure

No phase Interventional Surgical Site Infection (SSI) Wound Healing Complication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: subcutaneous suture.
Who it may be relevant to
Registry conditions: Surgical Site Infection (SSI), Wound Healing Complication. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Subcutaneous Suture Versus no Subcutaneous Suture for Abdominal Wound Closure in Abdominal Surgery

Overview

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.

Interventions

  • Procedure subcutaneous suture
    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 in

Primary outcome measures

  • SSI grade I or II according to CDC criteria within 30 days after surgery. [Time frame: 30 days after surgery]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Germany · 1 center
  • University Hospital Augsburg — Augsburg

Identifiers

NCT: NCT07615517 · 25-1085 · DRKS00039310

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗