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Reduction Of Surgical Site Infection using a Novel Intervention

Reduction Of Surgical Site Infection using a Novel Intervention: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN40402832
Enrollment
769
Registered
2009-10-14
Start date
2010-02-22
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Wound infection Injury, Occupational Diseases, Poisoning Complications of procedures, not elsewhere classified

Interventions

The intervention is the use of a 'wound edge protector', a device which is placed in the wound during surgery and aims to reduce contamination of the wound edges and therefore reduce post-operative wo

Sponsors

University Hospitals Birmingham NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All adults (greater than 18 years of age, either sex) undergoing laparotomy via a midline incision (for any surgical indication), including both elective and emergency operations.

Exclusion criteria

Exclusion criteria: 1. Patients less than 18 years of age, or unable to give informed consent 2. Laparoscopic-assisted cases

Design outcomes

Primary

MeasureTime frame
Incidence of post-operative wound infection, assessed at 7 and 30 days

Secondary

MeasureTime frame
Assessed at 30 days: 1. Health related quality of life 2. Length of hospital stay 3. Cost effectiveness 4. The effect on the efficacy of a wound edge protection device in reducing wound infection of: 4.1. Degee of abdominal contamination 4.2. Comorbidity 4.3. Duration of surgery 4.4. Grade of surgeon closing the wound

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 28, 2026