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

NCT ID: NCT01577225

Last Updated: 2017-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OPSITE Post-Op Visible

Subject is randomized to OPSITE Post-Op Visible group or Tape\&Gauze group. Dressing should be used right after surgery and changed as needed.

Group Type: EXPERIMENTAL

OPSITE POST-OP VISIBLE

Intervention Type: DEVICE

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

Tape&Gauze

Subject is randomized to OPSITE Post-Op Visible group or Tape\&Gauze group. Tape and Gauze should be used right after surgery and changed as per routin practice.

Group Type: ACTIVE_COMPARATOR

Tape and Gauze

Intervention Type: DEVICE

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

Interventions

OPSITE POST-OP VISIBLE

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

Intervention Type: DEVICE

Tape and Gauze

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients undergoing "clean surgery" in an operating room
• Patients whose wounds will be closed surgically and not left to heal by secondary intention.
• Patients who are in-patients and are expected to be so for at least 5 days or are willing to return to the site for dressing changes.
• Patients who are at least 18 years of age.Patients who understand the trial and are willing to consent to the trial
• Patients who are willing to attend the post-discharge follow-up assessment.
• Patients whose wounds are up to 27cm in length (as measured from end to end in a straight line)
• Patients whose wounds are expected to have low to moderate exudate.

Exclusion Criteria

• Pregnant or lactating females
• Patients undergoing chemotherapy, radiation therapy or taking any medication which is known to adversely affect wound healing
• Patients with a known medical condition or status known to delay or prevent normal wound healing such as diabetes, HIV, collagen vascular disorders and primary immune disorders
• Patients with a known sensitivity to any components of the investigational products or other similar dressings/products
• Patients with a history of poor compliance with medical treatment
• Patients who have participated in the study and who healed or were withdrawn.
• Patients who are unable to understand the aims and objectives of the trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew Medical (Shanghai) Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bingfang Zeng

Role: STUDY_CHAIR

Shanghai 6th People's Hospital

Locations

The First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Beijing Jishuitan Hospital

Beijing, , China

Peking Union Medical College Hospital

Beijing, , China

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Shanghai Sixth People's Hospital

Shanghai, , China

Countries

China

Other Identifiers

CT10/02

Identifier Type: -

Identifier Source: org_study_id