Prospective PuraPly™ AM Case Series Study

Completed

• Conditions: Venous Ulcers; Diabetic Ulcers; Trauma Wounds; Surgical Wounds; Pressure Ulcers

• Registration Number: NCT03070925
• Lead Sponsor: Organogenesis

Brief Summary

The PuraPly AM case series is a prospective, observational study for patients who have received PuraPly AM which consists of a collagen sheet coated with polyhexamethylene biguanide hydrochloride (PHMB) and is intended for the management of wounds; no experimental intervention is involved.

Detailed Description

The purpose of the case series is to assess the ability of PuraPly AM to meet wound specific treatment goals including management of bioburden, support of granulation tissue formation, and support of wound closure. Patients will undergo clinical assessments and receive the standard of care as determined by the treating physician.

The case series is being undertaken to better understand PuraPly AM utilization and subsequent healing outcomes as well as to evaluate the effects of concomitant wound therapy on healing. Patient's participation may involve follow-up for up to 12 weeks following application of PuraPly AM.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-12-02
• Study First Submitted QC: 2017-03-03
• Study First Posted: 2017-03-06
• Primary Completion: 2017-04
• Study Completion: 2017-05
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-29
• Last Update Posted: 2017-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

1. Participant is at least 18 years of age

2. Participant has read, understood and signed and Institutional Review Board (IRB) approved Informed Consent Form (ICF).

3. Participant has at least 1 wound appropriate for receiving PuraPly AM, including

   • Partial and full-thickness wounds
   • Pressure ulcers
   • Venous ulcers
   • Diabetic ulcers
   • Chronic vascular ulcers
   • Tunneled/undermined wounds
   • Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence)
   • Trauma wounds (abrasions, lacerations, second-degree burns, skin tears)
   • Draining wounds

Exclusion Criteria

1. Participant has a known sensitivity to porcine materials
2. Participant has a third-degree burn
3. Participant has a known sensitivity to polyhexamethylene biguanide hydrochloride (PHMB)
4. Participants receiving concurrent treatment with other topical antimicrobials or skin substitute products

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in wound bed condition	12 Weeks	As measured from change in status from baseline

Trial Locations

Locations (1)

Northwell Health, Inc; 🇺🇸 Lake Success, New York, United States