Subcutaneous Suture Versus no Subcutaneous Suture for Abdominal Wound Closure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Augsburg
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
subcutaneous suture
Procedure/SurgeryAfter 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)
Treatment groups
655 Participants
are divided into 2 treatment groupsGroup A: No subcutaneous sutureNo intervention 0 interventions
Group B: with subcutaneous sutureExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
30 days after surgerySponsors and contacts
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Source ClinicalTrials.gov