NCT02511600

Brief Summary

The goal of this clinical research study is to compare Progel® (a type of surgical sealant that is made from human blood products) to the standard of care (talcum powder) to learn if one method is better than the other for preventing air leaks in patients having a pleurectomy decortication.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Last Updated

December 15, 2015

Status Verified

December 1, 2015

Enrollment Period

3 years

First QC Date

July 28, 2015

Last Update Submit

December 14, 2015

Conditions

Lung DiseasesMesothelioma

Keywords

Lung DiseasesMesotheliomaPleurectomy decorticationProgelTalcum powderPain questionnairesSurveysIntraoperative air leaksIAL

Outcome Measures

Primary Outcomes (1)

  • Time to Resolve Air Lung Leak After Pleurectomy Decortication

    Primary outcome is T = time to resolve an air leak in the lungs, allowing the possibility that an air leak may not develop, represented by T=0.

    Participants followed for the duration of hospital stay, at least 5 days.

Study Arms (2)

Progel Sealant

EXPERIMENTAL

After pleurectomy decortication, Progel® sealant added to the surface of the lung prior to closure of the chest. Participants complete pain scale 3 times each day while in the hospital.

Other: Progel SealantBehavioral: Pain Questionnaire

Standard of Care

ACTIVE COMPARATOR

After pleurectomy decortication, talcum powder added to the surface of the lung prior to closure of the chest. Participants complete pain scale 3 times each day while in the hospital.

Other: Talcum PowderBehavioral: Pain Questionnaire

Interventions

Progel SealantOTHER

After pleurectomy decortication, Progel® sealant added to the surface of the lung prior to closure of the chest.

Progel Sealant
Talcum PowderOTHER

After pleurectomy decortication, talcum powder added to the surface of the lung prior to closure of the chest.

Standard of Care
Pain QuestionnaireBEHAVIORAL

Participants complete pain scale 3 times each day while in the hospital. Pain is rated on a pain scale of 0 - 10.

Also known as: Survey
Progel SealantStandard of Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with mesothelioma or other pathologies undergoing a pleurectomy decortication at MD Anderson Cancer Center
  • Adequate preoperative renal function documented by serum creatinine of \< 1.5 mg/dl or calculated creatinine clearance \> 50 ml/min

You may not qualify if:

  • Patients unable to consent for the procedure
  • Patients with a history of allergy to human proteins
  • Patients who may have insufficient renal capacity for clearance of Progel® polyethylene glycol load

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Lung DiseasesMesothelioma

Interventions

TalcSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Mesothelial

Intervention Hierarchy (Ancestors)

Magnesium SilicatesMagnesium CompoundsInorganic ChemicalsSilicatesMineralsSilicic AcidSilicon DioxideSilicon CompoundsData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Reza J. Mehran, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2015

First Posted

July 30, 2015

Study Start

December 1, 2015

Primary Completion

December 1, 2018

Last Updated

December 15, 2015

Record last verified: 2015-12