Trial Outcomes & Findings for Clinical Utility of a New Silver Gel for Use on Chronic Wounds (NCT NCT01442103)

Results Overview

Signs and symptoms of local wound infection/inflammation will be assessed by visual infection assessment (including body temperature) and wound status.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

4 weeks

Results posted on

2016-04-14

Participant Flow

The recruitment period was from 15 September 2011 - 01 May 2012. The study was conducted at the Advanced Burn and Wound Clinic at the Joseph M. Still Burn Center in Augusta, Georgia.

PreAssignment details: There was not wash-out or run-in phase included in the study. Subjects were expected to have at least 2 signs of local irritation or inflammation but no active or systemic infection at the time of consent.

Participant milestones

Participant milestones
Measure	Silver Gel, Chronic Wounds The patients will present with chronic wounds in need of initial treatment prior to initiating standard of care (i.e. wound bed with eschar or slough), in need of treatment after debridement or with presenting inflammation along with need for treatment.Only one wound will be chosen for treatment in the study and the area should not exceed 10x10 cm and not be deeper than 6 cm. Photos of the wound will be taken at each visit.
Overall Study STARTED	10
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Silver Gel, Chronic Wounds The patients will present with chronic wounds in need of initial treatment prior to initiating standard of care (i.e. wound bed with eschar or slough), in need of treatment after debridement or with presenting inflammation along with need for treatment.Only one wound will be chosen for treatment in the study and the area should not exceed 10x10 cm and not be deeper than 6 cm. Photos of the wound will be taken at each visit.
Overall Study Lost to Follow-up	2

Baseline Characteristics

Clinical Utility of a New Silver Gel for Use on Chronic Wounds

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Silver Gel, Chronic Wounds n=10 Participants Open, non-comparative, single-centre investigation exploring the clinical utility of a new silver gel for use on chronic wounds.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	58.7 years STANDARD_DEVIATION 18.7 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Popul for the asses.of safety was incld all subjs that received at least one device and that provided data after baseline. Prim.analys:ITT, popul incld all subjs that provid.data for the prim endpoint Parameters were summ for the ITT popul using apt sum. statistics. Data described in a descriptive manner only. Efficacy endpoints were sum.by visit.

Signs and symptoms of local wound infection/inflammation will be assessed by visual infection assessment (including body temperature) and wound status.

Outcome measures

Outcome measures
Measure	Device Common Dressing n=10 Participants Normlgel® Ag is an opaque, amorphous hyrdrogel containing a high (\>80%) water content and water soluble polymer chains.
Resolution of Signs and Symptoms of Local Wound Infection/Inflammation.	8 participants

SECONDARY outcome

Timeframe: 4 weekks

Erythema, edema, warmth, increased drainage, foul odor and fever will be assessed at each visit.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks

VAS pain scale will be used to measuring pain at each dressing change.

Outcome measures

Outcome data not reported

Adverse Events

Device Common Dressing

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

Molnlycke Health Care

Phone: +1 706-650-1012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place