Patients Undergoing Clean SurgeryOPOVNCT01577225
OPSITE Post-Op Visible Wound Dressings in Treatment of Surgical Incisions
A study testing OPSITE POST-OP VISIBLE and Tape and Gauze in people with Patients Undergoing Clean Surgery, run by Smith & Nephew Medical (Shanghai) Ltd at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Patients Undergoing Clean Surgery
- What is being tested?
- OPSITE POST-OP VISIBLE and Tape and Gauze
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 6 sitesChina
- Study dates
- Nov 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Beijing Jishuitan Hospital
Beijing, 100035
Peking Union Medical College Hospital
Beijing, 100730
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510080
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200092
Shanghai Sixth People's Hospital
Shanghai, 200233
About this study
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.
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.
Read the 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.
- Conditions
- Patients Undergoing Clean Surgery
- Being tested
- OPSITE POST-OP VISIBLE, Tape and Gauze
- Keywords
- Clean surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPSITE POST-OP VISIBLEDevice
Patient will be treated with OPSITE POST-OP VISIBLE dressing up to 14 days post surgery
Tape and GauzeDevice
Patient will be treated with tape and gauze up to 14 days post surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Tape and Gauze |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average wear time per patient
Average wear time per patient = Sum of evaluation dressing wear times for a patient/number of dressing applications
Measured: 0-14 days after surgery
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0-14 days after surgery
Patient comfort
Whether the dressing was comfortable during wear will be summarised by treatment and overall.
Measured: 0-14 days after surgery
Dressing removal parameters
The reasons for dressing change will be summarised by treatment and overall.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0-30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startNov 2011
- Primary completionApr 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Clean SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew Medical (Shanghai) Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bingfang Zeng, Study chair, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577225
- Sponsor's protocol ID
- CT10/02
- Acronym
- OPOV
- Status last verified
- Apr 2013
- First submitted
- 12 Apr 2012
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01577225
- Acronym / sponsor ID
- OPOV / CT10/02
- Conditions
- Patients Undergoing Clean Surgery
- Keywords
- Clean surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Smith & Nephew Medical (Shanghai) LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 13 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPSITE Post-Op Visible | Experimental | Device: OPSITE POST-OP VISIBLESubject is randomized to OPSITE Post-Op Visible group or Tape\&Gauze group. Dressing should be used right after surgery and changed as needed. |
| Tape&Gauze | Active comparator | Device: Tape and GauzeSubject 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPSITE POST-OP VISIBLEPatient will be treated with OPSITE POST-OP VISIBLE dressing up to 14 days post surgery | Device | OPSITE Post-Op Visible |
| Tape and GauzePatient will be treated with tape and gauze up to 14 days post surgery | Device | Tape&Gauze |
Primary outcome
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
14 secondary outcomes
Dressing wear time
Time frame: 0-14 days after surgery
Infection
Time frame: 0-30 days after surgery
Clinical signs of infection
Time frame: 0-30 days after surgery
Dehiscence
Time frame: 0-14 days after surgery
Exudate management
Time frame: 0-14 days after surgery
Condition of the surrounding skin (under the dressing)
Time frame: 0-14 days after surgery
Patient comfort
Time frame: 0-14 days after surgery
Dressing removal parameters
Time frame: 0-14 days after surgery
Dressing conformability
Time frame: 0-14 days after surgery
Ease of application and removal
Time frame: 0-14 days after surgery
Wound visibility through the dressing (OPOV dressings only)
Time frame: 0-14 days after surgery
Wound closure
Time frame: 0-30 days after surgery
Length of hospital stay
Time frame: 0-14 days after surgery
Complications
Time frame: 0-30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bingfang Zeng study chair
Shanghai 6th People's Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPSITE POST-OP VISIBLE and Tape and Gauze in people with Patients Undergoing Clean Surgery, run by Smith & Nephew Medical (Shanghai) Ltd at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average wear time per patient (time frame: 0-14 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.