Trial Outcomes & Findings for The Effect of OASIS Ultra on Critical Sized Wound Healing (NCT NCT01848821)

Results Overview

High-resolution digital photographs of the wound are taken (with a measurement scale included in the picture) at baseline and during serial wound evaluations in the operating room, at the bedside, and in the clinic. The picture is then uploaded into a wound tracing software program (Analyzing Digital images, www.umassk12.net/adki/) and wound area is calculated. Only the Baseline Measure and Final Wound Evaluation are used to calculate the Primary Outcome.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

7 participants

Primary outcome timeframe

Baseline, Final Wound Evaluation up to 60 Days Later

Results posted on

2019-10-30

Participant Flow

Unit of analysis: wound halves

Participant milestones

Participant milestones
Measure	OASIS OASIS Ultra (Porcine derived intestinal submucosa) to half of the wound. Negative Pressure Wound Therapy (NPWT) aka wound VAC will be placed on the OASIS half of the wound.	Standard Therapy Standard therapy to half of wound will consistent of non-adherent dressing and overlying VAC application. Negative Pressure Wound Therapy (NPWT) aka wound VAC will be placed on the standard therapy half of the wound.
Overall Study STARTED	7 10	7 10
Overall Study COMPLETED	7 10	7 10
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of OASIS Ultra on Critical Sized Wound Healing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OASIS Half of Wound n=10 Wound halves OASIS will be applied to one half of the wound and standard of care consisting of wound vac only will be applied to the other half. OASIS Ultra: Porcine derived intestinal submucosa	Standard Therapy Half of Wound n=10 Wound halves Standard therapy to half of wound will consistent of non-stick mesh and wound VAC application. Wound VAC Standard Therapy: Negative pressure wound device aka wound VAC will be placed on the standard therapy half of the wound	Total n=20 Wound halves Total of all reporting groups
Age, Customized Years	51.4 years STANDARD_DEVIATION 24.1 • n=5 Participants	51.4 years STANDARD_DEVIATION 24.1 • n=7 Participants	51.4 years STANDARD_DEVIATION 24.1 • n=5 Participants
Sex/Gender, Customized Female	1 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Sex/Gender, Customized Male	6 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants
Days from first debridement to OASIS application	6 days n=5 Participants	6 days n=7 Participants	6 days n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Final Wound Evaluation up to 60 Days Later

High-resolution digital photographs of the wound are taken (with a measurement scale included in the picture) at baseline and during serial wound evaluations in the operating room, at the bedside, and in the clinic. The picture is then uploaded into a wound tracing software program (Analyzing Digital images, www.umassk12.net/adki/) and wound area is calculated. Only the Baseline Measure and Final Wound Evaluation are used to calculate the Primary Outcome.

Outcome measures

Outcome measures
Measure	OASIS n=10 wound halves OASIS Ultra (Porcine derived intestinal submucosa) to half of the wound. Negative Pressure Wound Therapy (NPWT) aka wound VAC will be placed on the OASIS half of the wound.	Standard Therapy n=10 wound halves Standard therapy to half of wound will consistent of non-adherent dressing and overlying VAC application. Negative Pressure Wound Therapy (NPWT) aka wound VAC will be placed on the standard therapy half of the wound.
Change in Wound Size From Baseline to Final Wound Evaluation up to 60 Days Later	-20.7 cm^2 Interval -30.3 to -13.8	-13.9 cm^2 Interval -26.3 to

SECONDARY outcome

Timeframe: Baseline, Final Skin Grafting Procedure

At baseline and at every dressing change up to the skin grafting procedure, tissue biopsies for histopathological evaluation are obtained using a disposable dermal biopsy punch (8-mm diameter) or scalpel and locations of the biopsy sites within the wound are systematically rotated. Only biopsies from the Baseline and Final Skin Grafting Procedure are used to calculate this outcome measure. Parameters of acute inflammation (polymorphonuclear neutrophil infiltrate, edema, hemorrhage, and necrosis) were semiquantitatively assessed using a scoring system as follows: 0, non/minimal; 1, mild; 2, moderate, 3, marked. Each parameter was assigned a score, for a minimum and maximum total possible score of 0 and 12. A higher score represents a higher degree of acute inflammation.

Outcome measures

Outcome measures
Measure	OASIS n=10 wound halves OASIS Ultra (Porcine derived intestinal submucosa) to half of the wound. Negative Pressure Wound Therapy (NPWT) aka wound VAC will be placed on the OASIS half of the wound.	Standard Therapy n=10 wound halves Standard therapy to half of wound will consistent of non-adherent dressing and overlying VAC application. Negative Pressure Wound Therapy (NPWT) aka wound VAC will be placed on the standard therapy half of the wound.
Change in Histological Acute Inflammation Score From Baseline to Skin Grafting Procedure	-2.5 Histolotical Acute Inflammation Score Interval -3.3 to -1.0	0 Histolotical Acute Inflammation Score Interval -1.3 to 1.3

SECONDARY outcome

Timeframe: Baseline, final Skin Grafting procedure

At baseline and at every dressing change up to the skin grafting procedure, tissue biopsies for histopathological evaluation are obtained using a disposable dermal biopsy punch (8-mm diameter) or scalpel and locations of the biopsy sites within the wound are systematically rotated. Parameters of tissue repair (fibroblast proliferation, collagen density, and neovascularization) were semiquantitatively assessed using a scoring system as follows: 0, none/minima; 1, mild; 2, moderate; 3, marked. Each parameter was assigned a score for a total minimum and maximum possible score of 0 and 9. A higher score represents more advanced wound healing.

Outcome measures

Outcome measures
Measure	OASIS n=10 wound halves OASIS Ultra (Porcine derived intestinal submucosa) to half of the wound. Negative Pressure Wound Therapy (NPWT) aka wound VAC will be placed on the OASIS half of the wound.	Standard Therapy n=10 wound halves Standard therapy to half of wound will consistent of non-adherent dressing and overlying VAC application. Negative Pressure Wound Therapy (NPWT) aka wound VAC will be placed on the standard therapy half of the wound.
Change in Histological Repair Score From Baseline to Skin Grafting Procedure	4.5 Histological Repair Score Interval -0.25 to 6.0	2.5 Histological Repair Score Interval 1.0 to 4.25

Adverse Events

OASIS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Therapy

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

Dr. Daniel Dante Yeh, Assistant Professor of Surgery

Massachusetts General Hospital

Phone: 617-724-8604

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place