Trial Outcomes & Findings for Open, Prosp, Rand. Invest. Evaluating Pain With Mepitel One vs.Bridal Veil and Staples on Split Thickness Skin Grafts (NCT NCT01365273)

Results Overview

Pain was measured with Visual Analogue Scale (VAS)(100 mm) measuring from 0 = "no pain" at one end to 100 = "most intense pain imagaginable" at the other end.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

43 participants

Primary outcome timeframe

At visit 6, day 7

Results posted on

2014-02-13

Participant Flow

Date of first patient included: 26 April 2011 Date of last patient completed: 01 December 2011

Participant milestones

Participant milestones
Measure	Bridal Veil and Staples Bridal Veil and staples are standard of care I	Mepitel One Device
Overall Study STARTED	22	21
Overall Study Compl. Pts, Not Evaluable for Pain.	2	4
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Bridal Veil and Staples Bridal Veil and staples are standard of care I	Mepitel One Device
Overall Study Lost to Follow-up	1	0
Overall Study Protocol Violation	0	1
Overall Study Physician Decision	1	0

Baseline Characteristics

Open, Prosp, Rand. Invest. Evaluating Pain With Mepitel One vs.Bridal Veil and Staples on Split Thickness Skin Grafts

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bridal Veil and Staples n=22 Participants Bridal Veil and staples are standard of care I	Mepitel One n=21 Participants Device	Total n=43 Participants Total of all reporting groups
Age, Continuous	42.3 years STANDARD_DEVIATION 16.0 • n=5 Participants	38.0 years STANDARD_DEVIATION 18.0 • n=7 Participants	40.15 years STANDARD_DEVIATION 17 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	16 Participants n=7 Participants	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: At visit 6, day 7

Population: All subjects to post-randomization treatment and that provided some data for the primary endpoint were included in the ITT analysis.

Pain was measured with Visual Analogue Scale (VAS)(100 mm) measuring from 0 = "no pain" at one end to 100 = "most intense pain imagaginable" at the other end.

Outcome measures

Outcome measures
Measure	Bridal Veil and Staples n=20 Participants Bridal Veil and staples are standard of care I	Mepitel One n=17 Participants Device
VAS Score for Pain Before Dressing Removal	11.0 units on a scale Standard Deviation 21.0	4.0 units on a scale Standard Deviation 20.1

PRIMARY outcome

Timeframe: Visit 6, day 7

Population: All included subjects to post-randomization treatment and that provided some data for the primary endpoint was included in the Intention To Treat analyses.

Pain when half of the study product(s) has been removed measued with Visual Analogue Scale (VAS).0 = "no pain" till 100 = "worst pain".

Outcome measures

Outcome measures
Measure	Bridal Veil and Staples n=20 Participants Bridal Veil and staples are standard of care I	Mepitel One n=17 Participants Device
VAS Score for Pain During Dressing Removal	44.0 units on a scale Standard Deviation 28.6	4.0 units on a scale Standard Deviation 21.4

PRIMARY outcome

Timeframe: Visit 6, day 7

Population: All subjects to post-randomization treatment and that provided some data for the primary endpoint were included in the ITT analysis.

Pain after the dressing removal measued with Visual Analogue Scale (VAS).0 = "no pain" till 100 = "worst pain".

Outcome measures

Outcome measures
Measure	Bridal Veil and Staples n=20 Participants Bridal Veil and staples are standard of care I	Mepitel One n=17 Participants Device
VAS Score for Pain After Dressing Removal	21.0 units on a scale Standard Deviation 34.7	3.0 units on a scale Standard Deviation 21.1

Adverse Events

Bridal Veil and Staples

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mepitel One

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

Joan Wilson, MSN, MHA, RN

Monlycke Health Care

Phone: 706 504 8997

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor is the owner of the results.
Publication restrictions are in place

Restriction type: OTHER