Pressure Ulcer
Conditions
Keywords
Pressure Ulcers, Bed sores, Long-term care, Nursing home
Brief summary
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®.
Interventions
BIOLOGICALSantyl
Collagenase ointment applied topically
BIOLOGICALSoloSite®
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.
Sponsors
Smith & Nephew, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- 1. Provide written informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information. 2. Eighteen (18) years of age or older, of either sex, and of any race. 3. Willing to comply with protocol instructions, including allowing all study assessments. 4. Subject is in-patient in a long-term care facility. 5. A pressure ulcer present with a surface area ≥ 1.0 cm2 and ≤ 64.0 cm2 confirmed using the ImageIQ EDCIQ mobile imaging system. Only one qualifying ulcer per subject will be selected for the study (selection based on greatest clinical need, as assessed by the Investigator). 6. The target ulcer must present with ≥85% necrotic, nonviable tissue as assessed by two independent image reviewers. 7. The target ulcer has not been previously treated with hydrogel (SoloSite®) or with SANTYL®. Prior ulcers at or near the same location may have been treated with these products. 8. No current infections requiring treatment with antibiotics (antibiotic use is permitted for the purpose of urinary tract infection prophylaxis, but this must be explicitly stated in the subject's chart). 9. Acceptable state of health and nutrition with pre-albumin levels of ≥ 10 mg/dL (0.10 g/L), per the Screening local lab report. This is not required if a pre-albumin test within range has been conducted within the last 30 days. 10. A hemoglobin A1c \< 7.9% per the Screening local lab report. This is not required if a hemoglobin A1c test within range has been conducted within the last 30 days. 11. Have adequate pressure redistribution to the affected area or off-loading if the ulcer is on a lower extremity. 12. No known allergies or sensitivities to either test article or the dressings. 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
- 1. Undergoing therapy with another investigational agent within thirty (30) days of Study Visit 1, or planned participation overlapping with this study. 2. Current oral steroid treatment with a daily dose exceeding 5 mg. 3. Inability to comply with off-loading. 4. If the ulcer is on a lower extremity, inadequate arterial blood flow to the affected limb as evidenced by an ankle brachial index (ABI) \<0.85. 5. Presence of callus requiring surgical debridement within 3 days of Study Visit 1. 6. Target ulcer with exposure of tendon, muscle or bone. 7. Medical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Ulcers With Complete Debridement | 6 weeks | For purposes of the primary analysis, the status of complete debridement was to be assessed from photographs by two independent reviewers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time in Days to Complete Debridement | 6 weeks | 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. |
| Percentage Reduction in Non-viable Tissue | 6 weeks | 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. |
| Percentage Reduction in Ulcer Area | 6 weeks | 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). |
| Pressure Ulcer Scale for Healing (PUSH) Score | 6 weeks | 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). |
| Wound Bed Sore (WBS) Score | 6 weeks | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Santyl Santyl collagenase ointment applied topically once per day for up to six weeks
Santyl: Collagenase ointment applied topically | 1 |
| 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. | 2 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Termination of Study by Sponsor | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Santyl | SoloSite® |
|---|---|---|---|
| Age, Customized Subject 01-001 | 74 years | 74 years | — |
| Age, Customized Subject 01-002 | 58 years | — | 58 years |
| Age, Customized Subject 01-008 | 46 years | — | 46 years |
| Ethnicity (NIH/OMB) Subject 01-001 Hispanic or Latino | 0 Participants | 0 Participants | — |
| Ethnicity (NIH/OMB) Subject 01-001 Not Hispanic or Latino | 1 Participants | 1 Participants | — |
| Ethnicity (NIH/OMB) Subject 01-001 Unknown or Not Reported | 0 Participants | 0 Participants | — |
| Ethnicity (NIH/OMB) Subject 01-002 Hispanic or Latino | 0 Participants | — | 0 Participants |
| Ethnicity (NIH/OMB) Subject 01-002 Not Hispanic or Latino | 1 Participants | — | 1 Participants |
| Ethnicity (NIH/OMB) Subject 01-002 Unknown or Not Reported | 0 Participants | — | 0 Participants |
| Ethnicity (NIH/OMB) Subject 01-008 Hispanic or Latino | 0 Participants | — | 0 Participants |
| Ethnicity (NIH/OMB) Subject 01-008 Not Hispanic or Latino | 1 Participants | — | 1 Participants |
| Ethnicity (NIH/OMB) Subject 01-008 Unknown or Not Reported | 0 Participants | — | 0 Participants |
| Pressure Ulcer Scale for Healing (PUSH) Score Subject 01-001 V1 PUSH Exudate Amount | 0 score on a scale | 0 score on a scale | — |
| Pressure Ulcer Scale for Healing (PUSH) Score Subject 01-001 V1 PUSH Tissue Type | 4 score on a scale | 4 score on a scale | — |
| Pressure Ulcer Scale for Healing (PUSH) Score Subject 01-001 Visit 1 (V1) PUSH Length/Width | NA score on a scale | NA score on a scale | — |
| Pressure Ulcer Scale for Healing (PUSH) Score Subject 01-002 V1 PUSH Exudate Amount | 0 score on a scale | — | 0 score on a scale |
| Pressure Ulcer Scale for Healing (PUSH) Score Subject 01-002 V1 PUSH Length/Width | NA score on a scale | — | NA score on a scale |
| Pressure Ulcer Scale for Healing (PUSH) Score Subject 01-002 V1 PUSH Tissue Type | 4 score on a scale | — | 4 score on a scale |
| Pressure Ulcer Scale for Healing (PUSH) Score Subject 01-008 V1 PUSH Exudate Amount | 1 score on a scale | — | 1 score on a scale |
| Pressure Ulcer Scale for Healing (PUSH) Score Subject 01-008 V1 PUSH Length/Width | NA score on a scale | — | NA score on a scale |
| Pressure Ulcer Scale for Healing (PUSH) Score Subject 01-008 V1 PUSH Tissue Type | 3 score on a scale | — | 3 score on a scale |
| Race (NIH/OMB) Subject 01-001 American Indian or Alaska Native | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Subject 01-001 Asian | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Subject 01-001 Black or African American | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Subject 01-001 More than one race | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Subject 01-001 Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Subject 01-001 Unknown or Not Reported | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Subject 01-001 White | 1 Participants | 1 Participants | — |
| Race (NIH/OMB) Subject 01-002 American Indian or Alaska Native | 0 Participants | — | 0 Participants |
| Race (NIH/OMB) Subject 01-002 Asian | 0 Participants | — | 0 Participants |
| Race (NIH/OMB) Subject 01-002 Black or African American | 1 Participants | — | 1 Participants |
| Race (NIH/OMB) Subject 01-002 More than one race | 0 Participants | — | 0 Participants |
| Race (NIH/OMB) Subject 01-002 Native Hawaiian or Other Pacific Islander | 0 Participants | — | 0 Participants |
| Race (NIH/OMB) Subject 01-002 Unknown or Not Reported | 0 Participants | — | 0 Participants |
| Race (NIH/OMB) Subject 01-002 White | 0 Participants | — | 0 Participants |
| Race (NIH/OMB) Subject 01-008 American Indian or Alaska Native | 0 Participants | — | 0 Participants |
| Race (NIH/OMB) Subject 01-008 Asian | 0 Participants | — | 0 Participants |
| Race (NIH/OMB) Subject 01-008 Black or African American | 0 Participants | — | 0 Participants |
| Race (NIH/OMB) Subject 01-008 More than one race | 0 Participants | — | 0 Participants |
| Race (NIH/OMB) Subject 01-008 Native Hawaiian or Other Pacific Islander | 0 Participants | — | 0 Participants |
| Race (NIH/OMB) Subject 01-008 Unknown or Not Reported | 0 Participants | — | 0 Participants |
| Race (NIH/OMB) Subject 01-008 White | 1 Participants | — | 1 Participants |
| Region of Enrollment United States | 3 Participants | 1 Participants | 2 Participants |
| Sex/Gender, Customized Subject 01-001 Female | 1 Participants | 1 Participants | — |
| Sex/Gender, Customized Subject 01-001 Male | 0 Participants | 0 Participants | — |
| Sex/Gender, Customized Subject 01-002 Female | 0 Participants | — | 0 Participants |
| Sex/Gender, Customized Subject 01-002 Male | 1 Participants | — | 1 Participants |
| Sex/Gender, Customized Subject 01-008 Female | 0 Participants | — | 0 Participants |
| Sex/Gender, Customized Subject 01-008 Male | 1 Participants | — | 1 Participants |
| Wound Bed Sore (WBS) Score Subject 01-001 V1 WBS Black Eschar | 0 score on a scale | 0 score on a scale | — |
| Wound Bed Sore (WBS) Score Subject 01-001 V1 WBS Edema | 2 score on a scale | 2 score on a scale | — |
| Wound Bed Sore (WBS) Score Subject 01-001 V1 WBS Exudate Amount | 2 score on a scale | 2 score on a scale | — |
| Wound Bed Sore (WBS) Score Subject 01-001 V1 WBS Greatest Wound Depth/Granul. | 2 score on a scale | 2 score on a scale | — |
| Wound Bed Sore (WBS) Score Subject 01-001 V1 WBS Peri-Ulcer Callus/Fibrosis | 2 score on a scale | 2 score on a scale | — |
| Wound Bed Sore (WBS) Score Subject 01-001 V1 WBS Peri-Ulcer Dermatitis | 2 score on a scale | 2 score on a scale | — |
| Wound Bed Sore (WBS) Score Subject 01-001 V1 WBS Pink Ulcer Bed | 2 score on a scale | 2 score on a scale | — |
| Wound Bed Sore (WBS) Score Subject 01-001 Visit 1 (V1) WBS Healing Edges | 2 score on a scale | 2 score on a scale | — |
| Wound Bed Sore (WBS) Score Subject 01-002 V1 WBS Black Eschar | 0 score on a scale | — | 0 score on a scale |
| Wound Bed Sore (WBS) Score Subject 01-002 V1 WBS Edema | 2 score on a scale | — | 2 score on a scale |
| Wound Bed Sore (WBS) Score Subject 01-002 V1 WBS Exudate Amount | 2 score on a scale | — | 2 score on a scale |
| Wound Bed Sore (WBS) Score Subject 01-002 V1 WBS Greatest Wound Depth/Granul. | 2 score on a scale | — | 2 score on a scale |
| Wound Bed Sore (WBS) Score Subject 01-002 V1 WBS Healing Edges | 2 score on a scale | — | 2 score on a scale |
| Wound Bed Sore (WBS) Score Subject 01-002 V1 WBS Peri-Ulcer Callus/Fibrosis | 2 score on a scale | — | 2 score on a scale |
| Wound Bed Sore (WBS) Score Subject 01-002 V1 WBS Peri-Ulcer Dermatitis | 2 score on a scale | — | 2 score on a scale |
| Wound Bed Sore (WBS) Score Subject 01-002 V1 WBS Pink Ulcer Bed | 2 score on a scale | — | 2 score on a scale |
| Wound Bed Sore (WBS) Score Subject 01-008 V1 WBS Black Eschar | 2 score on a scale | — | 2 score on a scale |
| Wound Bed Sore (WBS) Score Subject 01-008 V1 WBS Edema | 2 score on a scale | — | 2 score on a scale |
| Wound Bed Sore (WBS) Score Subject 01-008 V1 WBS Exudate Amount | 2 score on a scale | — | 2 score on a scale |
| Wound Bed Sore (WBS) Score Subject 01-008 V1 WBS Greatest Wound Depth/Granul. | 0 score on a scale | — | 0 score on a scale |
| Wound Bed Sore (WBS) Score Subject 01-008 V1 WBS Healing Edges | 1 score on a scale | — | 1 score on a scale |
| Wound Bed Sore (WBS) Score Subject 01-008 V1 WBS Peri-Ulcer Callus/Fibrosis | 2 score on a scale | — | 2 score on a scale |
| Wound Bed Sore (WBS) Score Subject 01-008 V1 WBS Peri-Ulcer Dermatitis | 2 score on a scale | — | 2 score on a scale |
| Wound Bed Sore (WBS) Score Subject 01-008 V1 WBS Pink Ulcer Bed | 2 score on a scale | — | 2 score on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 2 |
| other Total, other adverse events | 0 / 1 | 0 / 2 |
| serious Total, serious adverse events | 0 / 1 | 1 / 2 |
Outcome results
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.
Time frame: 6 weeks
Population: Due to early study termination by Sponsor, complete debridement assessment by independent review of ulcer photographs did not take place.
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.
Time frame: 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.
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).
Time frame: 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.
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Santyl | Pressure Ulcer Scale for Healing (PUSH) Score | Subject 01-001 V7 PUSH Exudate Amount | 1 score on a scale |
| Santyl | Pressure Ulcer Scale for Healing (PUSH) Score | Subject 01-001 V7 PUSH Tissue Type | 4 score on a scale |
| Unknown | Pressure Ulcer Scale for Healing (PUSH) Score | Subject 01-001 Visit 7/Exit (V7) PUSH Length/Width | — 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.
Time frame: 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.
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Santyl | Wound Bed Sore (WBS) Score | Subject 01-001 Visit 7/Exit (V7) WBS Healing Edges | 2 score on a scale |
| Santyl | Wound Bed Sore (WBS) Score | Subject 01-001 V7 WBS Black Eschar | 0 score on a scale |
| Santyl | Wound Bed Sore (WBS) Score | Subject 01-001 V7 WBS Greatest Wound Depth/Granul. | 1 score on a scale |
| Santyl | Wound Bed Sore (WBS) Score | Subject 01-001 V7 WBS Exudate Amount | 2 score on a scale |
| Santyl | Wound Bed Sore (WBS) Score | Subject 01-001 V7 WBS Edema | 2 score on a scale |
| Santyl | Wound Bed Sore (WBS) Score | Subject 01-001 V7 WBS Peri-Ulcer Dermatitis | 2 score on a scale |
| Santyl | Wound Bed Sore (WBS) Score | Subject 01-001 V7 WBS Peri-Ulcer Callus/Fibrosis | 2 score on a scale |
| Santyl | Wound Bed Sore (WBS) Score | Subject 01-001 V7 WBS Pink Ulcer Bed | 0 score on a scale |