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Skin closure by subcuticular suture or skin stapling after elective hepatobiliary and pancreatic surgery: a single-center, open-label parallel randomized clinical trial

Randomized clinical trial of prevention of superficial surgical-site infection in hepatobiliary and pancreatic surgery: skin closure by subcuticular suture vs. skin stapling

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN37315612
Enrollment
320
Registered
2020-01-14
Start date
2020-01-31
Completion date
Unknown
Last updated
2023-01-30

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

Conditions

Superficial surgical-site infection (sSSI) in elective oncological and non-oncological hepatobiliary and pancreatic surgery Surgery

Interventions

Fascial closure will be performed according to the most recent evidence in order to minimize the risk of dehiscence and fascial site infection. For fascial closure continuous suture with synthetic abs

Sponsors

Hospital Universitario Donostia
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult patients undergoing elective oncological and non-oncological hepatobiliary and/or pancreatic surgery that have approved and signed the informed consent document

Exclusion criteria

Exclusion criteria: 1. Emergency surgery 2. Contaminated surgery according to WHO criteria and CDC definition for surgery 3. Active intraabdominal infectious process at the time of the surgery 4. Requirement for re-intervention due to a major postoperative intraabdominal complication 5. Non-compliance of the previously defined and standardized skin closure protocol including WHO recommendations for prevention of surgical site infection 6. Patients declined to participate

Design outcomes

Primary

MeasureTime frame
sSSI rate measured by review of clinical records (i.e. medical history, daily medical records, complementary tests such as microbiological wound tests) at 30 days of follow-up

Secondary

MeasureTime frame
1. Incidence of sSSI measured using clinical records at 30 days of follow-up 2. Risk factors associated with sSSI measured using review of medical records, including baseline characteristics, previous medical background and variables related to the surgical procedure, at 30 days of follow-up 3. Hospital admission days measured using medical records at 30 days of follow-up

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 10, 2026