NCT01577225

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

A Prospective, Open, Randomised Controlled Trial to Compare OPSITE Post-Op Visible Wound Dressings With Standard Therapy in the Treatment of Surgical Incisions.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Smith & Nephew Medical (Shanghai) Ltd · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OPSITE Post-Op Visible (OPOV) is a post-operative dressing that has been developed to protect the wound from bacteria in the environment and absorb blood or other fluid exuding from the wound. The honeycomb nature of the dressing pad allows direct visibility of the wound through the dressing, minimising the need to expose the wound to the environment and the patient to the trauma of a dressing change just for the clinician to inspect the wound. OPOV is unique in combining these features and offers a real benefit over other standard post-operative dressing regimes.

Conditions

• Patients Undergoing Clean Surgery

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-04-01
• Completion: 2012-08-01
• First posted: 2012-04-13
• Last updated: 2017-04-26

Locations

6 sites across 1 country: China