Trial Outcomes & Findings for Use of 3M Cavilon Advanced Skin Protectant in the Management of Damaged Skin Around an Ostomy, Drain or Fistula (NCT NCT03057132)

Last Updated: 2024-12-02

Results Overview

The primary endpoint is the improvement of denuded skin (defined as clinical improvement from the baseline skin assessment) of the primary site of interest (ostomy). The primary response was the percent of skin at primary site of interest with epidermal loss observed at baseline and at 3 days post product application.

Recruitment status

TERMINATED

Study phase

Target enrollment

1 participants

Primary outcome timeframe

Baseline, 3 days

Results posted on

2024-12-02

Participant Flow

Participant milestones

Participant milestones
Measure	Cavilon Advanced Skin Protectant Single topical application of Cavilon Advanced Skin Protectant to skin around the ostomy
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of 3M Cavilon Advanced Skin Protectant in the Management of Damaged Skin Around an Ostomy, Drain or Fistula

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cavilon Advanced Skin Protectant n=1 Participants Cavion Advanced Skin Protectant was applied to one male subject.
Age, Customized Age of Subject	63 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Number of participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3 days

Population: One application of Cavilon Advanced Skin Protectant was applied around the ostomy site. Skin was assessed at baseline and at 3 days after product application.

Outcome measures

Outcome measures
Measure	Cavilon Advanced Skin Protectant n=1 Participants Assessed area around an ostomy and estimated the percentage of skin that was normal, intact with pink/redness, and had epidermal loss (denuded).
Percent of Epidermal Skin Loss at the Primary Site Assessed Baseline % epidermal loss	10 Percentage of epidermal skin loss
Percent of Epidermal Skin Loss at the Primary Site Assessed Day 3 % epidermal loss	0 Percentage of epidermal skin loss

PRIMARY outcome

Timeframe: Baseline, 3 days

Population: Pain was rated during and after cleansing at baseline and at Day 3, and during and after product application at baseline.

Improvement in pain from baseline to the end of the study. The Wong-Baker FACES® Pain Visual Analog Pain Scale was used to assess pain at each time point. Pain was assessed on a 0 (no pain) to 10 (worst pain) grading scale. Lower score is better.

Outcome measures

Outcome measures
Measure	Cavilon Advanced Skin Protectant n=1 Participants Assessed area around an ostomy and estimated the percentage of skin that was normal, intact with pink/redness, and had epidermal loss (denuded).
Pain Scores at the Primary Site Assessed Baseline Pain During Cleaning	2 units on a scale
Pain Scores at the Primary Site Assessed Baseline Pain After Cleaning	2 units on a scale
Pain Scores at the Primary Site Assessed Baseline Pain During Application	2 units on a scale
Pain Scores at the Primary Site Assessed Baseline Pain After Application	0 units on a scale
Pain Scores at the Primary Site Assessed Day 3 Pain During Cleaning	0 units on a scale
Pain Scores at the Primary Site Assessed Day 3 Pain After Cleaning	0 units on a scale

Adverse Events

Cavilon Advanced Skin Protectant

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

Joseph Rudolph, BSN, RN, CWOCN, DWC

Cancer Treatment Centers of America

Phone: (215) 537-4678

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place