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Oasis Donor Site Wounds Post-Market Study

Primary Purpose

Surgical Wound, Wound, Wounds and Injuries

Status

Recruiting

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Oasis ECM

standard wound care

About this trial

This is an interventional treatment trial for Surgical Wound focused on measuring Donor Site Wound

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Has a split thickness skin graft (STSG) donor site wound no greater than 14 x 20 cm in size requiring placement of a covering material.
Has at least 24 hours to consent to study participation.

Exclusion Criteria:

Age < 16 years
Patients who, in the opinion of the investigator, have co-morbidities that impair wound healing, such as:
1. Chronic inflammatory skin condition
2. Chronic liver failure
3. Chronic renal failure
4. Blood-borne viruses (Hep B, Hep C, HIV)
5. Peripheral vascular disease
6. Clinically significant anaemia
7. Uncontrolled diabetes
Need for use of the same harvest site (re-cropping)
History of radiation therapy to proposed donor site
Chronic use of medications known to impair wound healing
Chronic use of opioids or neuropathic pain agents
Suspected cellulitis, osteomyelitis or septicaemia
Patients undergoing haemodialysis
Patients requiring spinal/regional block
Patients on current anti-coagulant therapy
Unable or unwilling to provide informed consent
Unable or unwilling to comply with the study follow-up schedule, and procedures
Simultaneously participating in another investigational drug or device study (patient must have completed the follow-up phase for the primary endpoint of any previous study at least 30 days prior to enrolment in this study)
Allergy or hypersensitivity to materials that are porcine-based
Cultural or religious objection to the use of pig or porcine products
Known intolerance/allergy to standard wound care products
Presence of a local infection at the donor site and/or systemic infection

Sites / Locations

Manchester University NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Oasis ECM

Standard wound care

Arm Description

The patient will undergo harvesting of a split-thickness skin graft using a dermatome set at standard depth with the subsequent application Oasis Extracellular Matrix to their donor site wound.

The patient will undergo harvesting of a split-thickness skin graft using a dermatome set at standard depth with the subsequent application of standard wound care to their donor site wound.

Outcomes

Primary Outcome Measures

Donor site wound healing

To demonstrate the percentage of patients with wounds healed at day 14

Secondary Outcome Measures

Amount of pain, analgesic usage

Patient will record daily usage of analgesics in a diary, daily, over the first 14 days post-treatment

Amount of pain, patient perceived

Patient will use the Visual Analog Score (VAS) to record pain in a diary, daily, over the first 14 days post-treatment.

Cosmetic Outcome utilizing POSAS

Cosmesis of the donor site wound will be assessed 3- and 6-months post-treatment by using the Patient and Observer Scar Assessment Scale (POSAS).

Adverse Events

Summary of adverse events reported

Full Information

NCT ID

NCT04079348

First Posted

September 3, 2019

Last Updated

February 8, 2023

Sponsor

Cook Biotech Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT04079348

Brief Title

Oasis Donor Site Wounds Post-Market Study

Official Title

Feasibility Study to Compare OASIS Extracellular Matrix to Standard Wound Care for Treatment of Donor Site Wounds

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2020 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cook Biotech Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to demonstrate the safety and performance of Oasis extracellular matrix (ECM) when used as a treatment for donor site wounds in the United Kingdom. Oasis ECM is commercially available for the treatment of partial and full-thickness skin wounds, including chronic wounds, wounds from trauma, and wounds that occur during surgery, such as donor site wounds. The ability of the Oasis ECM to promote the healing of donor site wounds will be evaluated in this study. About 40 patients (20 in each arm) over 16 years old will be involved in this study at one center in the United Kingdom.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Surgical Wound, Wound, Wounds and Injuries, Wound Heal

Keywords

Donor Site Wound

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

A patient is suitable for inclusion in the study if the patient meets the following criteria, based on known information at the time of enrolment: 1. Has a split thickness skin graft (STSG) donor site wound no greater than 14 x 20 cm in size requiring placement of a covering material.

Masking

Outcomes Assessor

Masking Description

Randomization to treatment groups will be performed using a computer system to randomly assign subjects to treatment arms. Sealed envelopes numbered 1-40 will be provided to the study site. Patients will be assigned an envelope number upon providing informed consent. The envelope will be opened during the treatment procedure to minimize the risk of bias in patient assignment to the treatment group.

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Oasis ECM

Arm Type

Active Comparator

Arm Description

The patient will undergo harvesting of a split-thickness skin graft using a dermatome set at standard depth with the subsequent application Oasis Extracellular Matrix to their donor site wound.

Arm Title

Standard wound care

Arm Type

Active Comparator

Arm Description

The patient will undergo harvesting of a split-thickness skin graft using a dermatome set at standard depth with the subsequent application of standard wound care to their donor site wound.

Intervention Type

Device

Intervention Name(s)

Oasis ECM

Intervention Description

The patient will undergo harvesting of a split-thickness skin graft using a dermatome set at standard depth with the subsequent application of Oasis Extracellular Matrix to their donor site wound.

Intervention Type

Other

Intervention Name(s)

standard wound care

Intervention Description

The patient will undergo harvesting of a split-thickness skin graft using a dermatome set at standard depth with the subsequent application of standard wound care to their donor site wound.

Primary Outcome Measure Information:

Title

Donor site wound healing

Description

To demonstrate the percentage of patients with wounds healed at day 14

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Amount of pain, analgesic usage

Description

Patient will record daily usage of analgesics in a diary, daily, over the first 14 days post-treatment

Time Frame

14 days

Title

Amount of pain, patient perceived

Description

Patient will use the Visual Analog Score (VAS) to record pain in a diary, daily, over the first 14 days post-treatment.

Time Frame

14 days

Title

Cosmetic Outcome utilizing POSAS

Description

Cosmesis of the donor site wound will be assessed 3- and 6-months post-treatment by using the Patient and Observer Scar Assessment Scale (POSAS).

Time Frame

up to 6 months

Title

Adverse Events

Description

Summary of adverse events reported

Time Frame

up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Has a split thickness skin graft (STSG) donor site wound no greater than 14 x 20 cm in size requiring placement of a covering material. Has at least 24 hours to consent to study participation. Exclusion Criteria: Age < 16 years Patients who, in the opinion of the investigator, have co-morbidities that impair wound healing, such as: Chronic inflammatory skin condition Chronic liver failure Chronic renal failure Blood-borne viruses (Hep B, Hep C, HIV) Peripheral vascular disease Clinically significant anaemia Uncontrolled diabetes Need for use of the same harvest site (re-cropping) History of radiation therapy to proposed donor site Chronic use of medications known to impair wound healing Chronic use of opioids or neuropathic pain agents Suspected cellulitis, osteomyelitis or septicaemia Patients undergoing haemodialysis Patients requiring spinal/regional block Patients on current anti-coagulant therapy Unable or unwilling to provide informed consent Unable or unwilling to comply with the study follow-up schedule, and procedures Simultaneously participating in another investigational drug or device study (patient must have completed the follow-up phase for the primary endpoint of any previous study at least 30 days prior to enrolment in this study) Allergy or hypersensitivity to materials that are porcine-based Cultural or religious objection to the use of pig or porcine products Known intolerance/allergy to standard wound care products Presence of a local infection at the donor site and/or systemic infection

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jason Hodde, MS

Phone

765-497-3355

jason.hodde@cookbiotech.com

First Name & Middle Initial & Last Name or Official Title & Degree

Samantha Stevenson, BS

Phone

765-497-3355

sstevenson@cookbiotech.com

Facility Information:

Facility Name

Manchester University NHS Foundation Trust

City

Manchester

State/Province

England

ZIP/Postal Code

M13 9WL

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zeeshan Sheikh, MB ChB

First Name & Middle Initial & Last Name & Degree

Jacky Edwards, Bsc

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Oasis Donor Site Wounds Post-Market Study

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