Trial Outcomes & Findings for Study of SANTYL® vs Hydrogel (SoloSite®) for Pressure Ulcers (NCT NCT02718625)

Last Updated: 2020-03-10

Results Overview

For purposes of the primary analysis, the status of complete debridement was to be assessed from photographs by two independent reviewers.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

3 participants

Primary outcome timeframe

6 weeks

Results posted on

2020-03-10

Participant Flow

This study was conducted from 10October2016 to 09March2017. The study was cancelled by the sponsor due to low enrollment despite several attempts and measures to improve recruitment. Therefore, the study was not feasible to continue and an early termination was needed.

Participant milestones

Participant milestones
Measure	Santyl Santyl collagenase ointment applied topically once per day for up to six weeks Santyl: Collagenase ointment applied topically	SoloSite® SOLOSITE is a hydrogel wound dressing with preservatives. It can donate moisture to rehydrate non-viable tissue. It absorbs exudate while retaining its structure in the wound. SoloSite®: SOLOSITE is a hydrogel wound dressing with preservatives. It can donate moisture to rehydrate non-viable tissue. It absorbs exudate while retaining its structure in the wound.
Overall Study STARTED	1	2
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Santyl Santyl collagenase ointment applied topically once per day for up to six weeks Santyl: Collagenase ointment applied topically	SoloSite® SOLOSITE is a hydrogel wound dressing with preservatives. It can donate moisture to rehydrate non-viable tissue. It absorbs exudate while retaining its structure in the wound. SoloSite®: SOLOSITE is a hydrogel wound dressing with preservatives. It can donate moisture to rehydrate non-viable tissue. It absorbs exudate while retaining its structure in the wound.
Overall Study Adverse Event	0	1
Overall Study Termination of Study by Sponsor	0	1

Baseline Characteristics

Due to early study termination by Sponsor, data are presented by subject.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 6 weeks

Population: Due to early study termination by Sponsor, complete debridement assessment by independent review of ulcer photographs did not take place.

For purposes of the primary analysis, the status of complete debridement was to be assessed from photographs by two independent reviewers.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: Due to early study termination by Sponsor, complete debridement assessment by independent review of ulcer photographs did not take place and time (in days) to complete debridement was not calculated.

For purposes of this secondary analysis, the time (in days) to achieve complete debridement (as defined in the primary analysis) was to be calculated from the date of randomization visit to the date of which the subject's ulcer was deemed to have achieved complete debridement.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: Due to early study termination by Sponsor, the assessment of ulcer photographs by two independent reviewers did not take place; thus, the analysis of this secondary outcome was not possible.

For purposes of this secondary analysis, the assessment of percentage of non-viable necrotic tissue was to be assessed based on photograph review by two independent reviewers, with the reduction calculated as: percentage of non-viable necrotic tissue at Visit 1 - percentage of non-viable necrotic tissue at Visit 7.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: Due to early study termination by Sponsor, the independent reviewers' assessment of ulcer photographs did not take place; thus, the analysis of this secondary outcome was not possible.

For purposes of this secondary analysis, the percentage reduction in ulcer area was to be measured during ulcer photograph review by two independent reviewers, using the ImageIQ EDCIQ mobile imaging system, with the reduction calculated as: (\[ulcer area at Visit 1 - ulcer area at Visit 7 / ulcer area at Visit 1\] x 100).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: Due to early study termination by Sponsor, only one subject completed the study and underwent Visit 7/Exit assessments (in the Santyl group). Ulcer area measurements and scoring by independent reviewers did not occur; no PUSH length/width score was determined. No analyses were done and individual data are presented for the single completed subject.

For purposes of this secondary analysis, changes in wound status were to be measured by using the Pressure Ulcer Scale for Healing (PUSH) Tool. At Visits 1 and 7, the target ulcer was to be scored based on length/width (from 0 cm\^2 to \>24 cm\^2 on a scale of 1 to 10), exudate amount (from 'none' to 'heavy' on a scale of 0 to 3) , and tissue type ('closed' to 'necrotic tissue' on a scale of 0 to 4); from which a total PUSH score from the sum of scores for the three categories could be derived (ranging from 0 to 17). Higher scores indicated a worse response. The reduction in PUSH individual sub-scores and total PUSH scores were calculated as: (PUSH Score at Visit 1 - Push Score at Visit 7/Exit).

Outcome measures

Outcome measures
Measure	Santyl n=1 Participants Santyl collagenase ointment applied topically once per day for up to six weeks Santyl: Collagenase ointment applied topically	SoloSite® SOLOSITE is a hydrogel wound dressing with preservatives. It can donate moisture to rehydrate non-viable tissue. It absorbs exudate while retaining its structure in the wound. SoloSite®: SOLOSITE is a hydrogel wound dressing with preservatives. It can donate moisture to rehydrate non-viable tissue. It absorbs exudate while retaining its structure in the wound.
Pressure Ulcer Scale for Healing (PUSH) Score Subject 01-001 V7 PUSH Exudate Amount	1 score on a scale	—
Pressure Ulcer Scale for Healing (PUSH) Score Subject 01-001 V7 PUSH Tissue Type	4 score on a scale	—

SECONDARY outcome

Timeframe: 6 weeks

Population: Due to early study termination by Sponsor, only one subject completed the study and underwent Visit 7/Exit assessments (in the Santyl group). No analyses were done and individual data are presented for the single completed subject.

For purposes of this secondary analysis, changes in wound status were to be measured by using the Wound Bed Sore (WBS) score. At Visits 1 and 7, eight individual wound bed sore characteristics were scored, each on a scale of 0 to 2 (higher scores represented better outcomes), and then summed to derive the total WBS score (ranging from 0 to 16). The reduction in total WBS scores were calculated as: (Total WBS Score at Visit 1 - Total WBS Score at Visit 7/Exit).

Outcome measures

Outcome measures
Measure	Santyl n=1 Participants Santyl collagenase ointment applied topically once per day for up to six weeks Santyl: Collagenase ointment applied topically	SoloSite® SOLOSITE is a hydrogel wound dressing with preservatives. It can donate moisture to rehydrate non-viable tissue. It absorbs exudate while retaining its structure in the wound. SoloSite®: SOLOSITE is a hydrogel wound dressing with preservatives. It can donate moisture to rehydrate non-viable tissue. It absorbs exudate while retaining its structure in the wound.
Wound Bed Sore (WBS) Score Subject 01-001 Visit 7/Exit (V7) WBS Healing Edges	2 score on a scale	—
Wound Bed Sore (WBS) Score Subject 01-001 V7 WBS Black Eschar	0 score on a scale	—
Wound Bed Sore (WBS) Score Subject 01-001 V7 WBS Greatest Wound Depth/Granul.	1 score on a scale	—
Wound Bed Sore (WBS) Score Subject 01-001 V7 WBS Exudate Amount	2 score on a scale	—
Wound Bed Sore (WBS) Score Subject 01-001 V7 WBS Edema	2 score on a scale	—
Wound Bed Sore (WBS) Score Subject 01-001 V7 WBS Peri-Ulcer Dermatitis	2 score on a scale	—
Wound Bed Sore (WBS) Score Subject 01-001 V7 WBS Peri-Ulcer Callus/Fibrosis	2 score on a scale	—
Wound Bed Sore (WBS) Score Subject 01-001 V7 WBS Pink Ulcer Bed	0 score on a scale	—

Adverse Events

Santyl

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SoloSite®

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Santyl n=1 participants at risk Santyl collagenase ointment applied topically once per day for up to six weeks Santyl: Collagenase ointment applied topically	SoloSite® n=2 participants at risk SOLOSITE is a hydrogel wound dressing with preservatives. It can donate moisture to rehydrate non-viable tissue. It absorbs exudate while retaining its structure in the wound. SoloSite®: SOLOSITE is a hydrogel wound dressing with preservatives. It can donate moisture to rehydrate non-viable tissue. It absorbs exudate while retaining its structure in the wound.
General disorders Altered Mental Status	0.00% 0/1 • Approximately 7 weeks (i.e., study participation duration)	50.0% 1/2 • Number of events 1 • Approximately 7 weeks (i.e., study participation duration)

Other adverse events

Adverse event data not reported

Additional Information

Natasha Schappell, Clinical Study Manager

Smith & Nephew, Inc.

Phone: 817-302-3949

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place