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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPSITE POST-OP VISIBLE | Device | Patient will be treated with OPSITE POST-OP VISIBLE dressing up to 14 days post surgery |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bingfang Zeng | Shanghai 6th People's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Sun Yat-Sen University | Guangzhou | Guangdong | 510080 | China | ||
| West China Hospital of Sichuan University |
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| Tape and Gauze | Device | Patient will be treated with tape and gauze up to 14 days post 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. |
| 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 |
| Chengdu |
| Sichuan |
| 610041 |
| China |
| Beijing Jishuitan Hospital | Beijing | 100035 | China |
| Peking Union Medical College Hospital | Beijing | 100730 | China |
| Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | 200092 | China |
| Shanghai Sixth People's Hospital | Shanghai | 200233 | China |