Trial Outcomes & Findings for The Use of Specialised Amino Acid Mixture in Pressure Ulcer Wound Healing Rates- A Placebo Controlled Trial (NCT NCT01090076)

Results Overview

-Percentage viable tissue after 2 weeks The estimated change in proportion of viable and non-viable tissue was determined using area derived from planimetry via acetate tracings. The description of viable tissue was taken to mean granulating (red) or epithelising (pink) tissue, and non-viable tissue were taken as necrotic (black) or sloughy (green or yellow) tissue.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

weeks 1 to 2

Results posted on

2013-06-24

Participant Flow

26 subjects were recruited between June 2010 to June 2011 and all subjects were inpatients of Changi General Hospital. 23 subjects completed the trial.

Subjects were randomly assigned to either arm after an initial assessment by PI and wound nurses. There is no wash out period for this trial

Participant milestones

Participant milestones
Measure	Abound Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal)	Placebo Placebo x 2 sachets/d
Overall Study STARTED	12	14
Overall Study COMPLETED	11	12
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Abound Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal)	Placebo Placebo x 2 sachets/d
Overall Study Death	1	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

The Use of Specialised Amino Acid Mixture in Pressure Ulcer Wound Healing Rates- A Placebo Controlled Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abound n=12 Participants Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d	Placebo n=14 Participants Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Age Continuous	78.5 years STANDARD_DEVIATION 18.4 • n=5 Participants	74.3 years STANDARD_DEVIATION 12.4 • n=7 Participants	75.4 years STANDARD_DEVIATION 15.4 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment Singapore	12 participants n=5 Participants	14 participants n=7 Participants	26 participants n=5 Participants

PRIMARY outcome

Timeframe: weeks 1 to 2

-Percentage viable tissue after 2 weeks The estimated change in proportion of viable and non-viable tissue was determined using area derived from planimetry via acetate tracings. The description of viable tissue was taken to mean granulating (red) or epithelising (pink) tissue, and non-viable tissue were taken as necrotic (black) or sloughy (green or yellow) tissue.

Outcome measures

Outcome measures
Measure	Abound n=11 Participants Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal)	Placebo n=12 Participants Placebo x 2 sachets/d
% Viable Tissue	43.06 Percentage of viable tissue Standard Error 8.43	25.94 Percentage of viable tissue Standard Error 6.68

PRIMARY outcome

Timeframe: week 0 to 1

Percentage change in wound area after week 1

Outcome measures

Outcome measures
Measure	Abound n=11 Participants Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal)	Placebo n=12 Participants Placebo x 2 sachets/d
% Wound Area Week 1	-15.37 percent change Standard Error 7.64	-13.68 percent change Standard Error 7.68

PRIMARY outcome

Timeframe: Weeks 1 to 2

Percentage change in wound area after week 2

Outcome measures

Outcome measures
Measure	Abound n=11 Participants Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal)	Placebo n=12 Participants Placebo x 2 sachets/d
% Wound Area Week 2	-27.50 Percentage change Standard Error 10.11	-37.54 Percentage change Standard Error 7.33

Adverse Events

Abound

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Mr Alvin Wong

Changi General Hospital

Phone: 68504627

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place