Oasis Donor Site Wounds Post-Market Study

Sponsor

Cook Biotech Incorporated (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04079348

Collaborator

(none)

Enrollment

Location

Arms

27.9

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Wound Wound Wounds and Injuries Wound Heal	Device: Oasis ECM Other: standard wound care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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: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:

Single (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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Oasis ECM 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.	Device: Oasis ECM 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.
Active Comparator: Standard wound care 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.	Other: standard wound care 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.

Arm

Intervention/Treatment

Active Comparator: Oasis ECM

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.

Device: Oasis ECM

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.

Active Comparator: Standard wound care

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.

Other: standard wound care

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.

Outcome Measures

Primary Outcome Measures

Donor site wound healing [14 days]
To demonstrate the percentage of patients with wounds healed at day 14

Secondary Outcome Measures

Amount of pain, analgesic usage [14 days]
Patient will record daily usage of analgesics in a diary, daily, over the first 14 days post-treatment
Amount of pain, patient perceived [14 days]
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 [up to 6 months]
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 [up to 6 months]
Summary of adverse events reported

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts 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:
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Manchester University NHS Foundation Trust	Manchester	England	United Kingdom	M13 9WL

Sponsors and Collaborators

Cook Biotech Incorporated

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cook Biotech Incorporated

ClinicalTrials.gov Identifier:

NCT04079348

Other Study ID Numbers:

19-001

First Posted:

Sep 6, 2019

Last Update Posted:

Mar 10, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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

Keywords provided by Cook Biotech Incorporated

Donor Site Wound

Additional relevant MeSH terms:

Wounds and Injuries

Surgical Wound

Study Results

No Results Posted as of Mar 10, 2022