Trial Outcomes & Findings for The Efficacy of "MediHoney" to Facilitate Catheter Exit-Site Surgical Wound Healing (NCT NCT01230489)

Results Overview

The outcome measure is the length of time from implantation until the patient has first exit site infection or two years which ever is shortest.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

13 participants

Primary outcome timeframe

Two years

Results posted on

2018-08-17

Participant Flow

13 participants were recruited from surgical clinics.

Data is unavailable as no analysis has occurred. The study was terminated to due loss of communication between the surgical and research departments.

Participant milestones

Participant milestones
Measure	Surgical Catheter Dressings Participants were randomized to receive either a standard of care dressing to their surgical wound catheter exit site or the MediHoney dressing. Data is unavailable as no analysis has occurred. The study was terminated to due loss of communication between the surgical and research departments.
Overall Study STARTED	13
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Surgical Catheter Dressings Participants were randomized to receive either a standard of care dressing to their surgical wound catheter exit site or the MediHoney dressing. Data is unavailable as no analysis has occurred. The study was terminated to due loss of communication between the surgical and research departments.
Overall Study Death	2
Overall Study Adverse Event	2
Overall Study Treatment modality changed	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Surgical Catheter Dressings n=13 Participants Participants randomized to either standard of care dressings or Medihoney dressings to catheter exit sites. The numbers allocated to each arm is unknown. Data is unavailable as no analysis has occurred. The study was terminated to due loss of communication between the surgical and research departments.
Age, Customized Age 18 - 90 years	13 Participants n=13 Participants
Sex/Gender, Customized Unknown	13 Participants n=13 Participants
Region of Enrollment United States	13 Participants n=13 Participants

PRIMARY outcome

Timeframe: Two years

Population: Data is unavailable as no analysis has occurred. The study was terminated to due loss of communication between the surgical and research departments.

The outcome measure is the length of time from implantation until the patient has first exit site infection or two years which ever is shortest.

Outcome measures

Outcome data not reported

Adverse Events

Surgical Catheter Dressings

Serious events: 2 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Surgical Catheter Dressings n=13 participants at risk Participants randomized to either standard of care dressings or Medihoney dressings to catheter exit sites. Data is unavailable as no analysis has occurred. The study was terminated to due loss of communication between the surgical and research departments.
Gastrointestinal disorders Perforated bowel	7.7% 1/13 • Number of events 1
Gastrointestinal disorders Yeast Infection	7.7% 1/13 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Harold Moore

University of Missouri-Columbia

Phone: 5738824433

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place