Trial Outcomes & Findings for Efficacy of Platelet Enriched Plasma in Preventing Surgery for Patients With Chronic Tympanic Membrane Perforation (NCT NCT03837665)

Results Overview

Number of participants that are able to avoid surgery for their perforation.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

1 participants

Primary outcome timeframe

6 Weeks

Results posted on

2024-07-16

Participant Flow

Participant milestones

Participant milestones
Measure	PRP Treatment Participants receive platelet rich plasma treatment. Participants will be asked to make up to 5 trips to the clinic (one for eligibility, one for the PRP, three follow-up visits). Participation is expected to last up to about 6 weeks. After the second visit and application of PRP, patients will be monitored closely for any complications or concerns. This will include a follow up phone call 3-5 days after the initial application of PRP. Patients will also be followed closely in 2 week intervals or sooner should any problems or concerns arise. Platelet Rich Plasma: Platelet Rich Plasma (PRP) is blood plasma that has been enriched with platelets.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Platelet Enriched Plasma in Preventing Surgery for Patients With Chronic Tympanic Membrane Perforation

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 6 Weeks

Population: 0 participants reported because only 1 participant was enrolled and therefore confidentiality is an issue.

Number of participants that are able to avoid surgery for their perforation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 Weeks

Population: 0 participants reported because only 1 participant was enrolled and therefore confidentiality is an issue.

Size of perforation

Outcome measures

Outcome data not reported

Adverse Events

PRP Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hinrich Staecker, MD, PhD

University of Kansas Medical Center

Phone: 913-588-6701

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place