Three-dimensional solution for deep and tunneling wounds

Miro3D is designed for use in deep and tunneling wounds

  • 2cm thick collagen matrix designed for deep, tunneling and irregular wounds
  • Open and porous structure provides protective environment for wound management
  • Cut to desired size for full wall apposition and conformity to wound beds

Unlike 2D wound matrices, Miro3D provides volume in deep wounds

Broad range of clinical uses

  • Stage III and IV pressure ulcers
  • Necrotizing fasciitis
  • Partial and full-thickness wounds
  • Perirectal abscess
  • Wound dehiscence
  • Pilonidal sinus disease
  • Diabetic foot ulcers
  • Trauma wounds
  • Other tunneled and undermined wounds

Clinical Case Studies*

Pilonidal Sinus Abscess Successfully treated with Miro3D

Clinical Overview and History

Patient is a male with a history of recurrent pilonidal cyst infection (spontaneous drainage) with use of oral antibiotics.

Initial Findings

  • Presented in September 2022 with pilonidal cyst recurrence
  • Surgical consult conducted to perform excision of cyst

Treatment

On September 21, 2022, patient underwent a pilonidal cyst surgical excision without closure. Post excision, the wound measured 4cm x 3cm x 2.5cm in depth. A wound VAC with white foam dressing was applied at 125mmHg for 5 days post excision (Figure 1).

Post day 5, Miro3D (5cm x 5cm x 2cm size) was placed and secured using a full thickness suture technique (Figure 2). A wound VAC, using white foam dressing, was applied at 125mmHg for an additional 6 days.

Six days later, the wound VAC was removed. Wound site observation included complete incorporation of Miro3D and ingrowth of granulation tissue (Figure 3).

Over the next three weeks, daily moist to dry dressing changes were performed.

Figure 4 demonstrates the healing progression observed on week 2 of the 3 total weeks of daily dressing changes.

Conclusion and Post Procedure

After three weeks of dressing changes, post 29 days from the initial Miro3D application to the wound, observation of 100% wound healing without deformity was noted (Figure 5).

Summary

Miro3D quickly integrated into the native bed and within 7 days from placement of Miro3D, complete incorporation and ingrowth of granulation tissues was observed. Full healing was observed without deformity 29 days after placement of Miro3D.

From past experience in surgical excisions of pilonidal sinus abscess cases, I would anticipate this extent of healing only after approximately 3-4 months of treatment using daily dressing changes and weekly debridement.

Physician Information

Rodney Miller, MD, General Surgery, Crossroads Providers
Board-certified general surgeon with specialized training in robotic surgery. Dr. Miller obtained his medical degree and completed his general surgery residency at East Tennessee State University and has over 25 years of experience. Dr. Miller completed his fellowship in Laparoscopic Colectomy Hands-On from Washington University, a fellowship in Healogics Advanced Wound Care and Hyperbaric Oxygen Therapy in Destin Florida, and an Advanced Laparoscopic Nissen Education Curriculum from the University of Nebraska Medical Center School of Medicine.

Abdominal Surgical Dehiscence Post Panniculectomy With Miro3D Applied to Wound

Clinical Overview and History

Female patient who underwent a panniculectomy surgery in May 2022.

Initial Findings

Approximately two and half months later, the patient presented with an abdominal surgical wound dehiscence. The wound measured 8cm x 2cm x 0.5cm in depth with 2cm of medial tunneling.

A wound VAC was applied. The wound VAC dressing was disrupted and not repositioned which resulted in superficial skin breakdown on the superior part of the wound opening. The VAC was removed by the patient before the two week follow-up visit.

Treatment

Two weeks later, and because of the discontinued use of the wound VAC by the patient, the main wound measured 9cm x 2.7cm x 2cm in depth with 2.5cm of medial tunneling (Figure 1). Miro3D (5cm x 5cm x 2cm size) was applied to the tunneling space and the main body wound (Figure 2). The Miro3D was covered with Mepitel® dressing and secured with an ABD dressing. The patient was instructed to perform daily outer dressing changes and Vashe® wound solution rinses to keep the wound clean. A wound VAC was not reapplied.

Seven days following the initial placement of Miro3D, the wound measured 7.5cm x 2.5cm x 0.5cm in depth with no tunneling (Figure 3). The Miro3D was resorbed into the wound bed. Daily wet to dry dressing changes were initiated.

Three days later, the patient returned for a second application (Figure 4). A 5cm x 5cm x 2cm Miro3D was reapplied to the wound.

Four days after the second placement of Miro3D, the wound measured 7.25cm x 1.25cm x 0.5cm deep and Miro3D was noted as fully resorbed within the wound bed (Figure 5). The wound was washed with a wound solution and covered with a dry dressing. The patient was instructed to perform daily Vashe washes with dry dressing changes. The patient returned for follow-up appointments every one to three weeks as transportation resources allowed.

By day 54, following the second placement of Miro3D, the wound measured 2cm x 1cm x 0.4cm (Figure 6).


77 days from the second placement of Miro3D, observations of the wound included a significant reduction in size and continued wound healing (Figure 7).
On day 98, the wound measured 0.4cm x 0.4cm x 0.2cm (Figure 8).

Conclusion and Post Procedure

Full wound healing was observed in January 2023, which was 127 days from the initial Miro3D application to the wound (Figure 9).

Summary

In this case, the ability to cut and shape Miro3D to conform to the wound bed for full wound wall apposition in both the tunneling space and main wound bed was beneficial. Miro3D demonstrated volume replacement by quickly eliminating the initial tunneling area as well as reducing the size of the wound with the protection of the collagen scaffold. Full healing was achieved 127 days following the placement of Miro3D.

Physician Information

Moses K. Shieh, DO, FACOS, Medical Director & Founder of Surgical Healing Arts Center in Fort Myers, FL
Specializes in Advanced Laparoscopic Bariatric Surgery and General Surgery. Surgical Director of Robotic Surgery at Gulf Coast Medical Center (part of the Lee Health System) in Fort Myers and currently serves as a member of the Medical Executive committee. Wound Director for Landmark Hospital in Naples.

Stage IV Pressure Ulcer of Sacral Region

  • 81 year old
  • Hx of anal radiation, Necrotizing fasciitis, Stage IV pressure ulcer, Malnutrition
  • Underwent surgery 8/11/2021
  • Presented with 8/11/2021
  • Wound size: 25 cm x 12.5 cm dept 4 cm (sacral bone exposure)
  • Wound age: 8/11/2021
  • Previous tx – rotational flaps, wound vac, Cytal
  • Miro3D applied on 8/29/22
Wound: 10cm x 5cm x 1.5cm
Miro3D used = 5cm x 5cm x 2cm
Post – Day 7
No reapplication
Post – Day 9
Reapplication of Miro3D
Post – Day 12 Post – Day 19

*The experience depicted in these case studies may not be representative of all potential clinical outcomes. Results may vary by patient. Further study is necessary to determine the benefit of Miro3D in a variety of wound applications.

Available in four sizes that can be cut and shaped to fill and maintain direct contact with irregular wound beds

All sizes = 2cm thickness

Ordering Information

ITEM ID SIZE (cm) TOTAL (cm3)
3000 2 x 2 x 2 8
3005 3 x 3 x 2 18
3010 5 x 5 x 2 50
3015 10 x 5 x 2 100

Packaged 1 per box.

Miro3D wound matrix is indicated for the management of wounds, including: partial and full-thickness wounds; pressure ulcers; venous ulcers; chronic vascular ulcers; diabetic ulcers; tunneled, undermined wounds; trauma wounds (abrasion, lacerations, partial thickness burns, skin tears); drainage wounds; and surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence).

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
Refer to the Instructions for Use for a complete listing of the indications, contraindications, warnings and precautions. Information in this material is not a substitute for the product Instructions for Use.

Download IFU here.

Available in a fiber version designed for irregular wound beds

Ordering Information

ITEM ID SIZE (mg)
4000 100
4005 250
4010 500
4015 700

Packaged 1 per box.

Miro3D Fibers wound matrix is intended for the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, tunneled, undermined wounds, trauma wounds (abrasions, lacerations, second-degree bums, and skin tears), draining wounds, surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence).

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
Refer to the Instructions for Use for a complete listing of the indications, contraindications, warnings and precautions. Information in this material is not a substitute for the product Instructions for Use.

Download IFU here.

Product Inquiries and Orders

Call us at: 763-284-6780

Fax us at: 952-856-5085

Product Inquiries at: customerservice@reprisebio.com

SM-00198 Rev. G 02/23