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

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

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.

Study Overview

• Status: Completed
• Conditions: Patients Undergoing Clean Surgery
• Intervention / Treatment: Device: OPSITE POST-OP VISIBLE; Device: Tape and Gauze

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100730
    • Peking Union Medical College Hospital
  • Beijing, China, 100035
    • Beijing Jishuitan Hospital
  • Shanghai, China, 200092
    • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Shanghai, China, 200233
    • Shanghai Sixth People's Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital, Sun Yat-sen University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: OPSITE POST-OP VISIBLE; Patient will be treated with OPSITE POST-OP VISIBLE dressing up to 14 days post surgery
Active Comparator: 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.	Device: Tape and Gauze; Patient will be treated with tape and gauze up to 14 days post surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dressing wear time	Dressing wear time will be summarised by centre, type of surgical procedure, location of incision, incision length (≤ / > median) and level of exudate at the previous assessment for each treatment and overall.	0-14 days after surgery
Infection	Whether or not the wound was infected and if yes, whether it was superficial incisional, deep incisional or organ/space will be summarised at each dressing change, final assessment and 30 day post-surgery follow up by treatment and overall.	0-30 days after surgery
Clinical signs of infection	Clinical signs of infection will be summarised at each dressing change and final assessment will be summarised by centre, type of surgical procedure, incision length (≤ / > median), treatment and overall.	0-30 days after surgery
Dehiscence	Incidence of dehiscence during the treatment period, during the follow up period and during the study period and whether incidence of dehiscence was related to infection will be summarised by centre, type of surgical procedure, incision length (≤ / > median), treatment and overall.	0-14 days after surgery
Exudate management	The level of secretion/exudate will be summarised at each dressing change, final assessment and 30 day post-surgery follow up by centre, treatment and overall.	0-14 days after surgery
Condition of the surrounding skin (under the dressing)	Condition of the surrounding skin will be summarised at each dressing change and final assessment by centre, treatment and overall.	0-14 days after surgery
Patient comfort	Whether the dressing was comfortable during wear will be summarised by treatment and overall.	0-14 days after surgery
Dressing removal parameters	The reasons for dressing change will be summarised by treatment and overall.	0-14 days after surgery
Dressing conformability	Whether the dressing conformed to the area around the incision site upon dressing application and at dressing assessments will be summarised by treatment and overall.	0-14 days after surgery
Ease of application and removal	Ease of dressing application and ease of dressing will be summarised by treatment and overall.	0-14 days after surgery
Wound visibility through the dressing (OPOV dressings only)	Wound visibility through the dressing will be summarised at each dressing change assessment by treatment and overall. Additionally, this will be summarised by the level of exudate/secretion at the previous assessment.	0-14 days after surgery
Wound closure	Wound closure by 30 day post-surgery follow up treatment will be summarised by centre, type of surgical procedure, location of incision, incision length (≤ / > median), treatment and overall.	0-30 days after surgery
Length of hospital stay	Length of hospital stay will be summarised by baseline terms for centre, type of surgical procedure, location of incision and incision length (≤ / > median) for each treatment and overall.	0-14 days after surgery
Complications	Additional procedures as a result of complications (due to infection, dehiscence, haematoma, other) will be summarised by treatment and overall.	0-30 days after surgery

Collaborators and Investigators

• Sponsor: Smith & Nephew Medical (Shanghai) Ltd
• Investigators: Study Chair: Bingfang Zeng, Shanghai 6th people's hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: April 12, 2012
• First Submitted That Met QC Criteria: April 12, 2012
• First Posted (Estimate): April 13, 2012

Study Record Updates

• Last Update Posted (Actual): April 26, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Clean surgery
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: CT10/02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No