Clinical trial · Interventional

Betadine Pleurodesis Via Tunneled Pleural Catheters

Efficacy of Povidone-Iodine Instillation Via Tunneled Pleural Catheters in Achieving Pleurodesis: A Randomized Controlled Trial

NCT02975921CI-TRIAL-00036485withdrawnPhase 4ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): The site decided not to proceed with the protocol.

Summary

Brief summary (as posted)

The purpose of this study is to determine whether betadine (povidone-iodine) instillation during routine indwelling Tunneled Pleural Catheter (TPC) placement is efficacious in promoting pleurodesis and thus reducing the time to TPC removal.

Conditions

Conditions (6)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Malignant Pleural Effusion	—	UNRESOLVED	—
Pleural Effusion	—	UNRESOLVED	—
Pleural Effusion Due to Congestive Heart Failure	—	UNRESOLVED	—
Pleural Effusion in Conditions Classified Elsewhere	—	UNRESOLVED	—
Pleural Effusions, Chronic	—	UNRESOLVED	—
Pleurodesis	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Povidone-Iodine	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (4)

type
NO_INTERVENTION
label
Malignant Effusion - Usual Care
description
Patients who had a pleural effusion secondary to a malignant etiology and subsequently underwent tunneled pleural catheter (TPC) placement and had usual care during and afterwards. Usual care is the TPC only with no intrapleural medications. They would have nursing care in the recovery area afterwards and home nursing three times weekly.
type
EXPERIMENTAL
label
Malignant Effusion with Pleurodesis
description
Patients who had a pleural effusion secondary to a malignant etiology and subsequently underwent tunneled pleural catheter (TPC) placement and had intrapleural Povidone-Iodine administered at time of placement (100mL of 2% solution). They would have nursing care in the recovery area afterwards and home nursing three times weekly.
interventionNames
1. Drug: Povidone-Iodine
type
NO_INTERVENTION
label

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Requiring Tunneled Catheter Placement for a Pleural Effusion

Exclusion Criteria:

* Patient with a nonexpandable lung
* Non-english speaker

References

Publications (7)

BACKGROUNDAgarwal R, Khan A, Aggarwal AN, Gupta D. Efficacy & safety of iodopovidone pleurodesis: a systematic review & meta-analysis. Indian J Med Res. 2012 Mar;135(3):297-304. PMID 22561614
BACKGROUNDAhmed L, Ip H, Rao D, Patel N, Noorzad F. Talc pleurodesis through indwelling pleural catheters for malignant pleural effusions: retrospective case series of a novel clinical pathway. Chest. 2014 Dec;146(6):e190-e194. doi: 10.1378/chest.14-0394. PMID 25451360
BACKGROUNDHak CC, Sivakumar P, Ahmed L. Safety of indwelling pleural catheter use in patients undergoing chemotherapy: a five-year retrospective evaluation. BMC Pulm Med. 2016 Mar 11;16:41. doi: 10.1186/s12890-016-0203-7. PMID 26968653
BACKGROUNDLight RW. Pleural effusions. Med Clin North Am. 2011 Nov;95(6):1055-70. doi: 10.1016/j.mcna.2011.08.005. Epub 2011 Sep 25. PMID 22032427
BACKGROUNDPenz ED, Mishra EK, Davies HE, Manns BJ, Miller RF, Rahman NM. Comparing cost of indwelling pleural catheter vs talc pleurodesis for malignant pleural effusion. Chest. 2014 Oct;146(4):991-1000. doi: 10.1378/chest.13-2481. PMID 24832000
BACKGROUNDVan Meter ME, McKee KY, Kohlwes RJ. Efficacy and safety of tunneled pleural catheters in adults with malignant pleural effusions: a systematic review. J Gen Intern Med. 2011 Jan;26(1):70-6. doi: 10.1007/s11606-010-1472-0. Epub 2010 Aug 10. PMID 20697963
BACKGROUNDWalker S, Bibby AC, Maskell NA. Current best practice in the evaluation and management of malignant pleural effusions. Ther Adv Respir Dis. 2017 Feb;11(2):105-114. doi: 10.1177/1753465816671697. Epub 2016 Oct 24. PMID 27777372