Antiseptic Sutures and Wound Infection

University Hospital, Saarland

Status: Completed

Conditions: Wound Infection

Treatments: Device: Vicryl plus

Study type: Interventional

Funder types: Other

Identifiers

NCT00932503

Vicryl plus 1

Details and patient eligibility

About

The aim of this study was to ascertain if the use of Vicryl plus® reduced the number of wound infections after transverse laparotomy comparing to polydioxanon suture.

Full description

All patients are treated using clinical pathways (CP) to standardise surgical procedures in our high volume centre. Part of the clinical process management was the standardisation of wound incision and abdominal wall closure.

Wound closure is achieved by a two-layer technique using continuous absorbable loop suture. The suture length to incision length ratio is at least 4:1. The running sutures are 1 cm apart and at least 1.5 cm from the wound edge 14. In the first timeperiod (TP1), the CP step for fascia closure foresees a PDS loop suture (PDS II®, 150 cm, Ethicon GmbH, Norderstedt, Germany). After the recruitment of 400 patients, that CP step is altered to the use of a triclosan-coated polyglactin 910 loop suture (Vicryl plus®, 150 cm, Ethicon GmbH, Norderstedt, Germany). The primary outcome is the number of wound infections. Patients demographic and disease as well as procedure related data are collected in a clinical information system (ISHmed on SAP platform, GSD, Berlin, Germany) prospectively. Risk factors for poor wound healing, such as operation time, patients age, sex, body mass index, blood loss, peritonitis, antibiotics, and performance level classified according to the American Society of Anesthesiologists (ASA), are collected prospectively to compare the two groups.

Enrollment: 839 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• surgical pathologies accessed via transverse abdominal incision
• primary fascial closure

Exclusion criteria

• pregnancy
• age under 18 years
• open abdominal treatment
• known hypersensitivity agains PDS/Vicryl/Triclosan

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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839 participants in 2 patient groups

PDS II

No Intervention group

Description:

PDS II® loop suture was used for abdominal wall closure

Vicryl plus

Active Comparator group

Description:

antiseptic coated "Vicryl plus" was used for abdominal wall closure

Treatment:

Device: Vicryl plus