Clinical trial NCT01577225: OPSITE Post-Op Visible Wound Dressings in Treatment of Surgical Incisions
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
Overall status: COMPLETED
Phase: NA
Conditions: Patients Undergoing Clean Surgery
Keywords: Clean surgery
Lead sponsor: Smith & Nephew Medical (Shanghai) Ltd
Sponsor class: INDUSTRY
First posted: 2012-04-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Average wear time per patient
timeFrame: 0-14 days after surgery
Secondary outcomes:
measure: Dressing wear time
timeFrame: 0-14 days after surgery
measure: Infection
timeFrame: 0-30 days after surgery
measure: Clinical signs of infection
timeFrame: 0-30 days after surgery
measure: Dehiscence
timeFrame: 0-14 days after surgery
measure: Exudate management
timeFrame: 0-14 days after surgery
measure: Condition of the surrounding skin (under the dressing)
timeFrame: 0-14 days after surgery
measure: Patient comfort
timeFrame: 0-14 days after surgery
measure: Dressing removal parameters
timeFrame: 0-14 days after surgery
measure: Dressing conformability
timeFrame: 0-14 days after surgery
measure: Ease of application and removal
timeFrame: 0-14 days after surgery
measure: Wound visibility through the dressing (OPOV dressings only)
timeFrame: 0-14 days after surgery
measure: Wound closure
timeFrame: 0-30 days after surgery
measure: Length of hospital stay
timeFrame: 0-14 days after surgery
measure: Complications
timeFrame: 0-30 days after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Shanghai
country: China
facility: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
Study officials:
affiliation: Shanghai 6th People's Hospital
name: Bingfang Zeng
role: STUDY_CHAIR
References: