Trial Outcomes & Findings for Evaluation of Oxygen Diffusion Dressing for Accelerating Healing of Donor Site and Other Wounds (NCT NCT01268189)

Results Overview

Wounds are inspected on postoperative days 4, 8, and then every two days until the wound is deemed to be healed.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

number of days to healing

Results posted on

2015-10-09

Participant Flow

Participant milestones

Participant milestones
Measure	Burn Wound Patients Burn wound patients with experimental (oxyband) and control (Xeroform) dressings placed on 2 separate skin graft donor sites
Overall Study STARTED	20
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Oxygen Diffusion Dressing for Accelerating Healing of Donor Site and Other Wounds

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Burn Wound Patients n=17 Participants Burn wound patients with oxygen diffusing dressing placed on 1 donor skin graft site and standard of care (Xeroform) dressing placed on a 2nd donor skin graft
Age, Continuous	35 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Burn Size	9.2 percentage of total skin area n=5 Participants

PRIMARY outcome

Timeframe: number of days to healing

Wounds are inspected on postoperative days 4, 8, and then every two days until the wound is deemed to be healed.

Outcome measures

Outcome measures
Measure	Study Dressing n=17 Participants Oxygen diffusing dressing applied to wound Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound	Control Dressing n=17 Participants Xeroform (current standard of care) dressing applied to wound Control dressing: Xeroform control dressing applied to control wound
Healing Time for Donor Site Wounds	9.4 days Standard Deviation 1.7	12.4 days Standard Deviation 2.7

SECONDARY outcome

Timeframe: Post-Operative Day 4

Patient will be asked to rate pain 0-10 (0=no pain, 10=maximum pain) at the study site and the control site. Used Visual Analogue Scale (VAS) for this purpose.

Outcome measures

Outcome measures
Measure	Study Dressing n=17 Participants Oxygen diffusing dressing applied to wound Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound	Control Dressing n=17 Participants Xeroform (current standard of care) dressing applied to wound Control dressing: Xeroform control dressing applied to control wound
Pain Perceived by Patient	0.6 units on a scale Standard Deviation 1.6	1.6 units on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: Post-Operative Day 8

Outcome measures

Outcome measures
Measure	Study Dressing n=17 Participants Oxygen diffusing dressing applied to wound Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound	Control Dressing n=17 Participants Xeroform (current standard of care) dressing applied to wound Control dressing: Xeroform control dressing applied to control wound
Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site	0.4 units on a scale Standard Deviation 1.3	1.4 units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: Post-Operative Day 10

Outcome measures

Outcome measures
Measure	Study Dressing n=17 Participants Oxygen diffusing dressing applied to wound Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound	Control Dressing n=17 Participants Xeroform (current standard of care) dressing applied to wound Control dressing: Xeroform control dressing applied to control wound
Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site	0.3 units on a scale Standard Deviation 1	0.8 units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: Post-Operative Day 12

Outcome measures

Outcome measures
Measure	Study Dressing n=17 Participants Oxygen diffusing dressing applied to wound Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound	Control Dressing n=17 Participants Xeroform (current standard of care) dressing applied to wound Control dressing: Xeroform control dressing applied to control wound
Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site	0.2 units on a scale Standard Deviation 0.8	0.5 units on a scale Standard Deviation 1.2

Adverse Events

Study Dressing

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Control Dressing

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Study Dressing n=17 participants at risk Oxygen diffusing dressing applied to wound Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound	Control Dressing n=17 participants at risk Xeroform (current standard of care) dressing applied to wound Control dressing: Xeroform control dressing applied to control wound
Skin and subcutaneous tissue disorders Blistering	11.8% 2/17 • Number of events 2	11.8% 2/17 • Number of events 2

Additional Information

Leopoldo C. Cancio, COL, MC

USAISR

Phone: 210-916-3301

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place