PerClot Compared to Usual Care in Gynaecology Procedures

Not Applicable

Completed

• Conditions: Uterine Fibroids; Ovarian Cyst; Cancer; Endometriosis; Menorrhagia
• Interventions: Device: PerClot; Device: Floseal, Surgicel, Surgiflo, Arista; Procedure: Electrocautery/Diatermy

• Registration Number: NCT02835391
• Lead Sponsor: CryoLife Europa

Brief Summary

This study is a post market, multi-centre, randomised study evaluating PerClot compared to usual care. PerClot is a CE marked device and is currently used as a haemostat in gynaecological surgery throughout Europe. The purpose of this study is to collect additional post market data on its use in this indication.

Detailed Description

This study is a post market, multi-centre, randomised study evaluating PerClot compared to usual care.

All subjects in this randomized study will undergo a laparoscopic or open gynecological procedure such as hysterectomy, cystectomy, myomectomy, endometrial excision or ablation. Subjects will be randomized to receive PerClot or usual care.

This research will utilize a multi-center, prospective, randomized controlled study. The study will be conducted in2 study sites in Europe. An assumed sample of 90 subjects will be enrolled to evaluate the time to haemostasis. The enrollment of subjects to receive treatment will be based upon specific inclusion and exclusion criteria. Subjects will be randomized on a 1:1 basis to receive either PerClot or usual care. Data collected from both arms will be compared.

Usual care will be at the discretion of the surgeon and may include any other haemostat or diathermy/electrocautery.

Study Timeline

• Study First Submitted: 2015-07-31
• Study Start: 2015-11
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-13
• Study First Posted: 2016-07-18
• Primary Completion: 2017-07
• Study Completion: 2017-08
• Last Update Submitted: 2017-08-31
• Last Update Posted: 2017-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• Subject is ≥ 18 years of age
• Subject is undergoing gynecological procedure
• Subject is willing and able to comply with the protocol and follow up period
• Subject is willing and able to give written informed consent

Exclusion Criteria

• • Subject with a history of pelvic or abdominal radiotherapy (within 8 weeks)

  • Subject is pregnant or actively breastfeeding
  • Subject has a ruptured ectopic pregnancy
  • Subject has a medical history of abnormal coagulopathy or bleeding
  • Subject has a sensitivity to starch or starch derived materials
  • Subject has active or potential infection at the surgical site
  • Subject is currently enrolled in another study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PerClot	PerClot	PerClot® Polysaccharide Hemostatic System (PerClot) is a medical device composed of absorbable polysaccharide particles (AMPs) and delivery applicators. Investigators will have the option to choose 3g or 5g dependent on the requirements of the patient
Usual Care	Floseal, Surgicel, Surgiflo, Arista	Usual care will consist of any other haemostat the Investigator would normally use in the control of bleeding i.e arista, Floseal, surgical, surgiflo. If the Investigator would not normally use a haemostat to control bleeding then electrocautery or diathermy may be used in this arm
Usual Care	Electrocautery/Diatermy	Usual care will consist of any other haemostat the Investigator would normally use in the control of bleeding i.e arista, Floseal, surgical, surgiflo. If the Investigator would not normally use a haemostat to control bleeding then electrocautery or diathermy may be used in this arm

Primary Outcome Measures

Name	Time	Method
achievement of haemostasis (yes/no).	measured up to 10 minutes after application	visual observation of cessation of bleeding

Secondary Outcome Measures

Name	Time	Method
Absence of re-intervention for post-operative bleeding	within 30 days of initial surgery	No return to OR for bleeding

Trial Locations

Locations (1)

Bellvitge Hospital; 🇪🇸 Barcelona, Spain