PuraPly™ Antimicrobial Wound Matrix and Wound Management (PuraPlyAM)

Organogenesis

Status: Completed

Conditions: Surgical Wound; Venous Ulcer; Pressure Ulcer; Trauma Wound; Diabetic Ulcer

Treatments: Device: PuraPly™ Antimicrobial Wound Matrix

Study type: Observational

Funder types: Industry

Identifiers

NCT03070938

PuraPly AM Case Series

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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) h. Trauma wounds (abrasions, lacerations, second-degree burns, skin tears) i. 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 polyhexamethylenbiguanide hydrochloride (PHMB)
4. Participants receiving concurrent treatment with other topical antimicrobials or skin substitute products