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Business Decision
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This study is designed to compare SANTYL® versus hydrogel (SoloSite®) in the treatment of pressure ulcers for participants in a long-term care facility. After meeting study criteria, participants will be randomly assigned for application of SANTYL® or SoloSite® to their pressure ulcer for up to 6 weeks. A study previously conducted showed that in the long-term care setting, the removal of dead skin (debridement) with SANTYL® resulted in more participants achieving complete debridement, more rapidly than when SoloSite® is used. The goal of the present study is to confirm the results of the earlier study, demonstrating superior debridement outcomes for pressure ulcers of patients in long-term care as compared to ulcers managed with SoloSite®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Santyl | Experimental | Santyl collagenase ointment applied topically once per day for up to six weeks |
|
| SoloSite® | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Santyl | Biological | Collagenase ointment applied topically |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Ulcers With Complete Debridement | For purposes of the primary analysis, the status of complete debridement was to be assessed from photographs by two independent reviewers. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time in Days to Complete Debridement | 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. | 6 weeks |
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Inclusion Criteria -
Women of child-bearing potential (those who are not premenarchal, not surgically sterilized [hysterectomy or bilateral oophorectomy], or not post-menopausal), may participate in the study if they meet the following condition:
-A negative urine pregnancy test at screening
Exclusion Criteria -
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| Name | Affiliation | Role |
|---|---|---|
| Herbert B Slade, MD | Smith & Nephew, Inc. | Study Chair |
| Jaime E Dickerson, PhD | Smith & Nephew, Inc. | Study Director |
| Martha Kelso, RN | Wound Care Plus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lee's Summit | Missouri | 64086 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Santyl | Santyl collagenase ointment applied topically once per day for up to six weeks Santyl: Collagenase ointment applied topically |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Santyl | Santyl collagenase ointment applied topically once per day for up to six weeks Santyl: Collagenase ointment applied topically |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Due to early study termination by Sponsor, data are presented by subject. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Ulcers With Complete Debridement | For purposes of the primary analysis, the status of complete debridement was to be assessed from photographs by two independent reviewers. | Due to early study termination by Sponsor, complete debridement assessment by independent review of ulcer photographs did not take place. | Posted | 6 weeks |
|
Approximately 7 weeks (i.e., study participation duration)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Santyl | Santyl collagenase ointment applied topically once per day for up to six weeks Santyl: Collagenase ointment applied topically |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Altered Mental Status | General disorders | Systematic Assessment | Patient was experiencing altered mental status and was found to have a decreased level of consciousness by facility staff. Facility staff reported that the patient was unable to answer questions appropriately and was not speaking coherently. |
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Due to the early termination of the study by the sponsor and the number of subjects enrolled, data were not analyzed or summarized and were only listed by subject. The safety and efficacy of Santyl could not be assessed based on this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Natasha Schappell, Clinical Study Manager | Smith & Nephew, Inc. | 817-302-3949 | Natasha.Schappell@smith-nephew.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 5, 2016 | Sep 16, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D017364 | Collagenases |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| SoloSite® |
| Biological |
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. |
|
| Percentage Reduction in Non-viable Tissue |
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. |
| 6 weeks |
| Percentage Reduction in Ulcer Area | 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). | 6 weeks |
| Pressure Ulcer Scale for Healing (PUSH) Score | 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). | 6 weeks |
| Wound Bed Sore (WBS) Score | 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). | 6 weeks |
| BG002 | Total | Total of all reporting groups |
| Number |
| years |
|
| Sex/Gender, Customized | Due to early study termination by Sponsor, data are presented by subject. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Due to early study termination by Sponsor, data are presented by subject. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Due to early study termination by Sponsor, data are presented by subject. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Pressure Ulcer Scale for Healing (PUSH) Score | Changes in wound status were to be measured by using the Pressure Ulcer Scale for Healing (PUSH) Tool. For baseline assessments at Visit 1, 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. | Due to early termination by Sponsor, no collective analyses were completed and data are presented by individual subject. | Number | score on a scale |
|
| Wound Bed Sore (WBS) Score | Changes in wound status were to be measured by using the Wound Bed Sore (WBS) score. For the baseline assessment at Visit 1, 8 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). | Due to early termination by Sponsor, no collective analyses were completed and data are presented by individual subject. | Number | score on a scale |
|
|
| Secondary | Time in Days to Complete Debridement | 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. | 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. | Posted | 6 weeks |
|
|
| Secondary | Percentage Reduction in Non-viable Tissue | 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. | 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. | Posted | 6 weeks |
|
|
| Secondary | Percentage Reduction in Ulcer Area | 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). | 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. | Posted | 6 weeks |
|
|
| Secondary | Pressure Ulcer Scale for Healing (PUSH) Score | 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). | 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. | Posted | Number | score on a scale | 6 weeks |
|
|
|
| Secondary | Wound Bed Sore (WBS) Score | 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). | 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. | Posted | Number | score on a scale | 6 weeks |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | 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. | 0 | 2 | 1 | 2 | 0 | 2 |
|
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| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| Female |
|
| Female |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Subject 01-001 V7 PUSH Tissue Type |
|
|
| Title | Measurements |
|---|---|
|
| Subject 01-001 V7 WBS Exudate Amount |
|
| Subject 01-001 V7 WBS Edema |
|
| Subject 01-001 V7 WBS Peri-Ulcer Dermatitis |
|
| Subject 01-001 V7 WBS Peri-Ulcer Callus/Fibrosis |
|
| Subject 01-001 V7 WBS Pink Ulcer Bed |
|