Subcutaneous suture versus no subcutaneous suture for abdominal wound closure

Subcutaneous suture versus no subcutaneous suture for abdominal wound closure - SUTURE

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00039310

Enrollment

655

Registered

2026-02-17

Start date

2026-03-23

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SSI grade I or II according to CDC criteria

Interventions

Group 1: After standardized fascial closure according to institutional standards and subcutaneous irrigation with polyhexanide (Serasept®), patients are randomized to one of the following treatment gr

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult patients (=18 years) undergoing 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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
- Duration of wound closure (minutes; median; interquartile range [IQR]) - Requirement for postoperative antibiotic therapy due to surgical site infection (n; %) - Cosmetic outcome assessed by the Patient and Observer Scar Assessment Scale (POSAS) and/or the Patient Scar Assessment Questionnaire (PSAQ); - Global health-related quality of life assessed by the EORTC QLQ-C30 - Size and extent of wound healing disorder at 30 days postoperatively (length and width in cm) - Reoperation rate (n; %) - All surgical site infections (CDC grade I–III) - Complete wound healing at the end of follow-up (yes/no; n; %) - Hospital costs: total costs, costs related to treatment of wound healing disorder during hospital stay, and costs for dressing materials (€; median; IQR) - Length of hospital stay (days; median; IQR) - Association between intraoperative microbiological swab results and postoperative surgical site infection	—

Measure

Time frame

- Duration of wound closure (minutes; median; interquartile range [IQR]) - Requirement for postoperative antibiotic therapy due to surgical site infection (n; %) - Cosmetic outcome assessed by the Patient and Observer Scar Assessment Scale (POSAS) and/or the Patient Scar Assessment Questionnaire (PSAQ); - Global health-related quality of life assessed by the EORTC QLQ-C30 - Size and extent of wound healing disorder at 30 days postoperatively (length and width in cm) - Reoperation rate (n; %) - All surgical site infections (CDC grade I–III) - Complete wound healing at the end of follow-up (yes/no; n; %) - Hospital costs: total costs, costs related to treatment of wound healing disorder during hospital stay, and costs for dressing materials (€; median; IQR) - Length of hospital stay (days; median; IQR) - Association between intraoperative microbiological swab results and postoperative surgical site infection

—

Countries

Germany

Contacts

Public ContactJohannes Lauscher

Klinik für Allgemein-, Viszeral-, Transplantations- und Thoraxchirurgie

johannes.lauscher@uk-augsburg.de+49 8214002653

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026