MedTrace Logo

OPSITE Post-Op Visible Wound Dressings in Treatment of Surgical Incisions

NCT01577225 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-04-26

No results posted yet for this study

Summary

OPSITE Post-Op Visible is a tri-layer dressing made up of a low adherent wound contact layer, lattice shaped absorbent pad and a top film that is waterproof and a bacterial barrier and is coated with a water-based adhesive. The comparator is a standard care treatment regime comprising tape and gauze.

This study requires 100 eligible patients which will be recruited from the patients routinely see by the study investigators at each study site. Eligible patients will undergo surgery that results in a surgical wound of 27cm or less that is expected to have low or moderate levels of exudate and will have received at least one randomised study treatment. The primary objective is to compare OPOV and tape/gauze in terms of wear time per patient.

Conditions

  • Patients Undergoing Clean Surgery

Interventions

DEVICE

OPSITE POST-OP VISIBLE

Patient will be treated with OPSITE POST-OP VISIBLE dressing up to 14 days post surgery

DEVICE

Tape and Gauze

Patient will be treated with tape and gauze up to 14 days post surgery

Sponsors & Collaborators

  • Smith & Nephew Medical (Shanghai) Ltd

    lead INDUSTRY

Principal Investigators

  • Bingfang Zeng · Shanghai 6th People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-04-30
Completion
2012-08-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01577225 on ClinicalTrials.gov