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

Primary Purpose

Patients Undergoing Clean Surgery

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
OPSITE POST-OP VISIBLE
Tape and Gauze
Sponsored by
Smith & Nephew Medical (Shanghai) Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients Undergoing Clean Surgery focused on measuring Clean surgery

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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  • Patients who have participated in the study and who healed or were withdrawn.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.

Sites / Locations

  • The First Affiliated Hospital, Sun Yat-Sen University
  • West China Hospital of Sichuan University
  • Beijing Jishuitan Hospital
  • Peking Union Medical College Hospital
  • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Shanghai Sixth People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OPSITE Post-Op Visible

Tape&Gauze

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
Patient comfort
Whether the dressing was comfortable during wear will be summarised by treatment and overall.
Dressing removal parameters
The reasons for dressing change will be summarised by treatment and overall.
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.
Ease of application and removal
Ease of dressing application and ease of dressing will be summarised by treatment and overall.
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.
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.
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.
Complications
Additional procedures as a result of complications (due to infection, dehiscence, haematoma, other) will be summarised by treatment and overall.

Full Information

First Posted
April 12, 2012
Last Updated
April 24, 2017
Sponsor
Smith & Nephew Medical (Shanghai) Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01577225
Brief Title
OPSITE Post-Op Visible Wound Dressings in Treatment of Surgical Incisions
Acronym
OPOV
Official Title
A Prospective, Open, Randomised Controlled Trial to Compare OPSITE Post-Op Visible Wound Dressings With Standard Therapy in the Treatment of Surgical Incisions.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smith & Nephew Medical (Shanghai) Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients Undergoing Clean Surgery
Keywords
Clean surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OPSITE Post-Op Visible
Arm Type
Experimental
Arm Description
Subject is randomized to OPSITE Post-Op Visible group or Tape&Gauze group. Dressing should be used right after surgery and changed as needed.
Arm Title
Tape&Gauze
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
OPSITE POST-OP VISIBLE
Intervention Description
Patient will be treated with OPSITE POST-OP VISIBLE dressing up to 14 days post surgery
Intervention Type
Device
Intervention Name(s)
Tape and Gauze
Intervention Description
Patient will be treated with tape and gauze up to 14 days post surgery
Primary Outcome Measure Information:
Title
Average wear time per patient
Description
Average wear time per patient = Sum of evaluation dressing wear times for a patient/number of dressing applications
Time Frame
0-14 days after surgery
Secondary Outcome Measure Information:
Title
Dressing wear time
Description
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.
Time Frame
0-14 days after surgery
Title
Infection
Description
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.
Time Frame
0-30 days after surgery
Title
Clinical signs of infection
Description
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.
Time Frame
0-30 days after surgery
Title
Dehiscence
Description
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.
Time Frame
0-14 days after surgery
Title
Exudate management
Description
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.
Time Frame
0-14 days after surgery
Title
Condition of the surrounding skin (under the dressing)
Description
Condition of the surrounding skin will be summarised at each dressing change and final assessment by centre, treatment and overall.
Time Frame
0-14 days after surgery
Title
Patient comfort
Description
Whether the dressing was comfortable during wear will be summarised by treatment and overall.
Time Frame
0-14 days after surgery
Title
Dressing removal parameters
Description
The reasons for dressing change will be summarised by treatment and overall.
Time Frame
0-14 days after surgery
Title
Dressing conformability
Description
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.
Time Frame
0-14 days after surgery
Title
Ease of application and removal
Description
Ease of dressing application and ease of dressing will be summarised by treatment and overall.
Time Frame
0-14 days after surgery
Title
Wound visibility through the dressing (OPOV dressings only)
Description
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.
Time Frame
0-14 days after surgery
Title
Wound closure
Description
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.
Time Frame
0-30 days after surgery
Title
Length of hospital stay
Description
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.
Time Frame
0-14 days after surgery
Title
Complications
Description
Additional procedures as a result of complications (due to infection, dehiscence, haematoma, other) will be summarised by treatment and overall.
Time Frame
0-30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bingfang Zeng
Organizational Affiliation
Shanghai 6th People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
The First Affiliated Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Beijing Jishuitan Hospital
City
Beijing
ZIP/Postal Code
100035
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
ZIP/Postal Code
200092
Country
China
Facility Name
Shanghai Sixth People's Hospital
City
Shanghai
ZIP/Postal Code
200233
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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