Interim study results for GYNECARE INTERCEED™ Absorbable Adhesion Barrier in colorectal carcinoma patients undergoing two-phase laparoscopic colorectal surgery

A Dear Healthcare Professional Letter has been issued by Johnson & Johnson Pte Ltd to inform healthcare professionals of recent clinical study interim results which showed no statistically significant difference between the use of GYNECARE INTERCEED™ Absorbable Adhesion Barrier and not using an adhesion barrier, in preventing abdominal adhesions in patients with colorectal carcinoma undergoing two-phase laparoscopic hand-assisted colorectal resection. The study was terminated due to the lack of expected superior efficacy for INTERCEED™ as compared to Control (No Adhesion Barrier). No new safety issues were identified. In view of these results, the use of this product in general abdominal surgeries may cause the users to experience a lack of effect in terms of reducing the incidence, extent, and severity of adhesion formation. Additional medical or surgical intervention may be warranted to address or release the adhesions and prevent further injury. The study results do not impact or affect the safe and effective use of INTERCEED™ in open gynaecologic procedures. Healthcare professionals are advised to consider these study results in determining treatment of patients during general abdominal procedures. Healthcare professionals who have treated patients using this product according to its prescribing information are advised to follow those patients post-operatively in the usual manner with no additional action required. Please refer to the letter for details.
Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

25 May 2021

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on the MOH Alert System, which is accessible via the Health Professionals Portal (HPP). HPP is a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://www.hpp.moh.gov.sg/, and follow the procedures below to access the MOH Alert system.

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

Step 3: Click on the MOH Alert icon under the ‘Applications’ section.

Step 4: Click on the Drug Alert tab to view the DHCPLs.