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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew Medical (Shanghai) Ltd
ClinicalTrials.gov Identifier:
NCT01577225
First received: April 12, 2012
Last updated: April 2, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Patients Undergoing "Clean Surgery"
Device: OPSITE POST-OP VISIBLE
Device: Tape and Gauze
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Further study details as provided by Smith & Nephew Medical (Shanghai) Ltd:

Primary Outcome Measures:
  • Average wear time per patient [ Time Frame: 0-14 days after surgery ] [ Designated as safety issue: No ]
    Average wear time per patient = Sum of evaluation dressing wear times for a patient/number of dressing applications


Secondary Outcome Measures:
  • Dressing wear time [ Time Frame: 0-14 days after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0-30 days after surgery ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 0-30 days after surgery ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 0-14 days after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0-14 days after surgery ] [ Designated as safety issue: No ]
    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) [ Time Frame: 0-14 days after surgery ] [ Designated as safety issue: No ]
    Condition of the surrounding skin will be summarised at each dressing change and final assessment by centre, treatment and overall.

  • Patient comfort [ Time Frame: 0-14 days after surgery ] [ Designated as safety issue: No ]
    Whether the dressing was comfortable during wear will be summarised by treatment and overall.

  • Dressing removal parameters [ Time Frame: 0-14 days after surgery ] [ Designated as safety issue: No ]
    The reasons for dressing change will be summarised by treatment and overall.

  • Dressing conformability [ Time Frame: 0-14 days after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0-14 days after surgery ] [ Designated as safety issue: No ]
    Ease of dressing application and ease of dressing will be summarised by treatment and overall.

  • Wound visibility through the dressing (OPOV dressings only) [ Time Frame: 0-14 days after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0-30 days after surgery ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 0-14 days after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0-30 days after surgery ] [ Designated as safety issue: Yes ]
    Additional procedures as a result of complications (due to infection, dehiscence, haematoma, other) will be summarised by treatment and overall.


Enrollment: 100
Study Start Date: November 2011
Study Completion Date: August 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01577225

Locations
China, Guangdong
The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510080
China, Sichuan
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
China
Peking Union Medical College Hospital
Beijing, China, 100730
Beijing Jishuitan Hospital
Beijing, China, 100035
Shanghai Sixth People's Hospital
Shanghai, China, 200233
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200092
Sponsors and Collaborators
Smith & Nephew Medical (Shanghai) Ltd
Investigators
Study Chair: Bingfang Zeng Shanghai Sixth People's Hospital
  More Information

No publications provided

Responsible Party: Smith & Nephew Medical (Shanghai) Ltd
ClinicalTrials.gov Identifier: NCT01577225     History of Changes
Other Study ID Numbers: CT10/02
Study First Received: April 12, 2012
Last Updated: April 2, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Smith & Nephew Medical (Shanghai) Ltd:
Clean surgery

ClinicalTrials.gov processed this record on September 16, 2014