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The Use of Fibrin Sealant to Reduce Post Operative Pain in Cleft Palate Surgery

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ClinicalTrials.gov Identifier: NCT02953145
Recruitment Status : Recruiting
First Posted : November 2, 2016
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Brief Summary:

Cleft Palate is a condition which affects up to 1 in 500 live births. Current treatment is surgery to correct the underlying anomaly. Children born with cleft palate typically undergo surgery at age 12 months. Standard ways to stop surgical bleeding include direct pressure and the use of electrocautery (burning of the tissue). Other products are available to help lessen blood loss. One of these includes a fibrin sealant. Fibrin is the key component of a blood clot. When a fibrin sealant is applied there are a variety of potential benefits other than bleeding control. One of these is decreased pain post operatively It is the investigators belief that the use of a fibrin sealant, Tisseel, in cleft palate surgery will decrease pain and enhance the recovery of children who undergo cleft palate repair.

The proposed study will randomly select children undergoing cleft palate repair to have tisseel used on the incision. Through statistical tests 40 children will be recruited (20 to have tisseel used and 20 with no tisseel). The use of tisseel will be known to the surgeon but not to the recovery room or ward nursing staff. Post operatively, the FLACC pain scale will be used to score the pain of the children throughout their admission to the Stollery children's hospital. The amount of pain controlling medication required as well as time to discharge will also be recorded. Statistical analysis of the data will be performed using accepted methods. Overall, the investigators hope to show that fibrin sealant, tisseel, will less the amount of post operative pain experienced by children undergoing cleft palate repair.


Condition or disease Intervention/treatment Phase
Cleft Palate Drug: Tisseel Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Fibrin Sealant to Reduce Post Operative Pain in Cleft Palate Surgery
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tisseel applied
In this group, the fibrin sealant Tisseel will be applied as a hemostasis agent in patients undergoing primary palatoplasty
Drug: Tisseel
Tisseel will be applied to open areas lateral to the cleft palate repair
Other Name: fibrin sealant

No Intervention: No fibrin sealant
In this group, no fibrin sealant will be applied intra-operatively. Standard measures, such as electrocautery, will be used for hemostasis.



Primary Outcome Measures :
  1. Post operative pain [ Time Frame: time 1 hour post operation ]
    FLACC scores will be determined by blinded ward nurses and/or caregiver of the patient.

  2. Post operative pain [ Time Frame: time 2 hours post operation ]
    FLACC scores will be determined by blinded ward nurses and/or caregiver of the patient.

  3. Post operative pain [ Time Frame: time 4 hours post operation ]
    FLACC scores will be determined by blinded ward nurses and/or caregiver of the patient.

  4. Post operative pain [ Time Frame: time 6 hours post operation ]
    FLACC scores will be determined by blinded ward nurses and/or caregiver of the patient.

  5. Post operative pain [ Time Frame: time 12 hours post operation ]
    FLACC scores will be determined by blinded ward nurses and/or caregiver of the patient.

  6. Post operative pain [ Time Frame: time 24 hours post operation ]
    FLACC scores will be determined by blinded ward nurses and/or caregiver of the patient.

  7. Post operative pain [ Time Frame: time 48 hours post operation ]
    FLACC scores will be determined by blinded ward nurses and/or caregiver of the patient.

  8. Post operative pain [ Time Frame: time 72 hours post operation ]
    FLACC scores will be determined by blinded ward nurses and/or caregiver of the patient.


Secondary Outcome Measures :
  1. Requirement for analgesia [ Time Frame: From immediate post operative period up to 5 days ]
    Any analgesic given to the patient will be recorded and compared for the two groups.

  2. Time to discharge [ Time Frame: From immediate post operative period up to 5 days ]
    Patients are discharged from hospital when they are feeding adequately, pain is controlled and there are no other complications. The time when the patient meets discharge criteria as well as the time they actually leave the ward will be recorded and assessed in this study.

  3. Time to first feeding [ Time Frame: From immediate post operative period up to 5 days ]
    The time to successful feeding can be used as a marker for tolerable pain post operatively. The time when the patient first feeds successfully will be recorded and compared for the two groups.

  4. oronasal fistula [ Time Frame: Immediately post operatively until 2 years post operatively. ]
    Patients will be followed in the cleft lip and palate clinic . For the two years post operatively, repaired cleft palates will be examined for the presence of oronasal fistula.



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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing primary cleft palate repair (palatoplasty)
  • Informed consent from parent(s) or guardian(s)

Exclusion Criteria:

  • Allergy to any component of Tisseel
  • failure to obtain informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02953145


Contacts
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Contact: Curtis R Budden, MD MEd 780-232-2237 budden@ualberta.ca
Contact: Jaret L Olson, MD FRCSC 780-407-8108 jolson@ualberta.ca

Locations
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Canada, Alberta
Stollery Alberta Children's hospital Recruiting
Edmonton, Alberta, Canada, T6G2B7
Contact    7804071591      
Principal Investigator: Jaret L Olson, MD FRCSC         
Sub-Investigator: Curtis R Budden, MD B.Sc         
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Jaret L Olson, MD FRCSC University of Alberta

Publications:
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT02953145     History of Changes
Other Study ID Numbers: 45664
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cleft Palate
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Mouth Abnormalities
Mouth Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities
Fibrin Tissue Adhesive
Hemostatics
Coagulants