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

NCT01577225 | Completed

• 1 other identifier: CT10/02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

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.

Conditions

Patients Undergoing Clean Surgery

Keywords

Clean surgery

Outcome Measures

Primary Outcomes (1)

• Average wear time per patient

  Average wear time per patient = Sum of evaluation dressing wear times for a patient/number of dressing applications

  0-14 days after surgery

Secondary Outcomes (14)

• Dressing wear time

  0-14 days after surgery

• Infection

  0-30 days after surgery

• Clinical signs of infection

  0-30 days after surgery

• Dehiscence

  0-14 days after surgery

• Exudate management

  0-14 days after surgery

Study Arms (2)

OPSITE Post-Op Visible

EXPERIMENTAL

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

Device: OPSITE POST-OP VISIBLE

Tape&Gauze

ACTIVE COMPARATOR

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.

Device: Tape and Gauze

Interventions

OPSITE POST-OP VISIBLE DEVICE

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

OPSITE Post-Op Visible

Tape and Gauze DEVICE

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

Tape&Gauze

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Smith & Nephew Medical (Shanghai) Ltd: lead

Study Sites (6)

The First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Beijing Jishuitan Hospital

Beijing, 100035, China

Location

Peking Union Medical College Hospital

Beijing, 100730, China

Location

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

Shanghai, 200092, China

Location

Shanghai Sixth People's Hospital

Shanghai, 200233, China

Location

Study Officials

• Bingfang Zeng

  Shanghai 6th People's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2012
• First Posted: April 13, 2012
• Study Start: November 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: August 1, 2012
• Last Updated: April 26, 2017

Record last verified: 2013-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)