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

Not Applicable

Completed

• Conditions: Patients Undergoing Clean Surgery
• Interventions: Device: Tape and Gauze; Device: OPSITE POST-OP VISIBLE

• Registration Number: NCT01577225
• Lead Sponsor: Smith & Nephew Medical (Shanghai) Ltd

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.

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2012-04
• Study First Submitted: 2012-04-12
• Study First Submitted QC: 2012-04-12
• Study First Posted: 2012-04-13
• Study Completion: 2012-08
• Status Verified: 2013-04
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tape&Gauze	Tape and 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.
OPSITE Post-Op Visible	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.

Primary Outcome Measures

Name	Time	Method
Average wear time per patient	0-14 days after surgery	Average wear time per patient = Sum of evaluation dressing wear times for a patient/number of dressing applications

Secondary Outcome Measures

Name	Time	Method
Dehiscence	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.
Wound closure	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	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.
Clinical signs of infection	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.
Exudate management	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.
Dressing removal parameters	0-14 days after surgery	The reasons for dressing change will be summarised by treatment and overall.
Wound visibility through the dressing (OPOV dressings only)	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.
Complications	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.
Dressing wear time	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.
Infection	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.
Condition of the surrounding skin (under the dressing)	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.
Dressing conformability	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	0-14 days after surgery	Ease of dressing application and ease of dressing will be summarised by treatment and overall.
Patient comfort	0-14 days after surgery	Whether the dressing was comfortable during wear will be summarised by treatment and overall.

Trial Locations

Locations (6)

Beijing Jishuitan Hospital; 🇨🇳 Beijing, China

Shanghai Sixth People's Hospital; 🇨🇳 Shanghai, China

The First Affiliated Hospital, Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, China

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China