OPSITE POST-OP VISIBLE
DevicePatient will be treated with OPSITE POST-OP VISIBLE dressing up to 14 days post surgery
Completed
NCT Number: NCT01577225
OPSITE Post-Op Visible Wound Dressings in 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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–90 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China
Loading trial locations.
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Tape and Gauze
DevicePatient will be treated with tape and gauze up to 14 days post surgery
Primary outcomes
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Average wear time per patient
Time frame: 0-14 days after surgery
Average wear time per patient = Sum of evaluation dressing wear times for a patient/number of dressing applications
Secondary outcomes
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Dressing wear time
Time frame: 0-14 days after surgery
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.
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Infection
Time frame: 0-30 days after surgery
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.
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Clinical signs of infection
Time frame: 0-30 days after surgery
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
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
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.
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Condition of the surrounding skin (under the dressing)
Time frame: 0-14 days after surgery
Condition of the surrounding skin will be summarised at each dressing change and final assessment by centre, treatment and overall.
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Patient comfort
Time frame: 0-14 days after surgery
Whether the dressing was comfortable during wear will be summarised by treatment and overall.
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Dressing removal parameters
Time frame: 0-14 days after surgery
The reasons for dressing change will be summarised by treatment and overall.
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Dressing conformability
Time frame: 0-14 days after surgery
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
Ease of dressing application and ease of dressing will be summarised by treatment and overall.
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Wound visibility through the dressing (OPOV dressings only)
Time frame: 0-14 days after surgery
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.
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Wound closure
Time frame: 0-30 days after surgery
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
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.
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Complications
Time frame: 0-30 days after surgery
Additional procedures as a result of complications (due to infection, dehiscence, haematoma, other) will be summarised by treatment and overall.
Sponsors and collaborators
Lead sponsor
Smith & Nephew Medical (Shanghai) Ltd
Industry
Registry information
Official study title
A Prospective, Open, Randomised Controlled Trial to Compare OPSITE Post-Op Visible Wound Dressings With Standard Therapy in the Treatment of Surgical Incisions.
Acronym: OPOV
Important dates
- Study start
- 2011
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Apr 13, 2012
- Registry last updated
- Apr 26, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.