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Restrata®

Restrata® is a fully synthetic hybrid-scale fiber matrix manufactured with synthetic bioresorbable polymers and possesses a fibrous structure with high porosity. The product architecture, which is similar to native extracellular matrix, allows for cell ingress and retention, as well as neovascularization of the newly forming tissue without the need for added growth factors.

Acera Surgical, Inc

Acera Surgical, Inc. is a bioscience company developing engineered synthetic solutions for a variety of regenerative medical and surgical applications.
Toll free:(844) 879-2237 Fax:(844) 879-2237 Website: www.acera-surgical.com
Benefits

• Fully synthetic
• Excellent biocompatibility
• Versatility
• Consistency
• Ease-of-Use
• As the wound healing process progresses, Restrata® completely degrades via hydrolysis, leaving native tissue in its place
• Shelf stable and carries a 2-year shelf life

Indications

Restrata® is intended for the use in the management of wounds, including partial- and full-thickness wounds, pressure injuries, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (eg, donor site/grafts, post-laser surgery, post-Mohs surgery, podiatric wounds, dehisced wounds), trauma wounds (e.g. abrasions, lacerations, partial-thickness burns, skin tears, or draining wounds.

Contraindications

This device is not indicated for use in third-degree burns.
This device should not be used in patients with known sensitivity to resorbable suture materials.

Warnings and Precautions

• Do not use the product if there is evidence of container damage
• Do not use the product after the expiration date listed on the packaging
• Do not resterilize
• Device is sterile if the package is unopened and undamaged
• Discard device if mishandling has caused possible damage or contamination
• Debridement or excision must be done thoroughly to remove any remaining non-viable or necrotic tissue
that may cause infection
• Restrata® should not be applied until excessive exudate, bleeding, acute swelling, and infection is controlled

Adverse Effects/Reactions

Complications are possible such as chronic inflammation, infection, or allergic reaction. If any of these occur, the device should be removed

Storage Requirements

Store at room temperature. Avoid excessive heat or humidity. Refrigeration of Restrata® is not necessary.

Active Ingredients

Polyglactin 910 and polydioxanone

How Supplied/Sizing
Non-meshed: (1/2)"x1", 1"x1", 1"x2", 1(1/2)"x2", 1"x3", 2"x2", 3"x3", 4"x5", 5"x7". Meshed: 1(1/2)"x2", 2"x2", 3"x3", 4"x5", 5"x7".
HCPCS Code
Product features
cancel Biosynthetic
cancel Biosynthetic - animal-based
check_circle Indicated for chronic vascular ulcers
check_circle Indicated for diabetic ulcers
check_circle Indicated for draining wounds
check_circle Indicated for partial- and full-thickness wounds
check_circle Indicated for pressure ulcers
check_circle Indicated for surgical wounds
cancel Indicated for third-degree burns
check_circle Indicated for trauma wounds
check_circle Indicated for venous ulcers
check_circle Synthetic
check_circle Variety of sizes
check_circle Resorbable
cancel Contact manufacturer for usage guidelines
Other features
check_circle Educational Material Available
check_circle Free Samples/Trials Available
check_circle Published Clinical Article Available
Recommended Use

Acute Wounds
Burns
Chronic Wounds
Deep Wounds
Dehisced Wounds
Diabetic Foot
Granulating/Epithelializing Wounds
Moderate/Highly Exudating Wounds
Non/Minimally Exudating Wounds
Palliative Wounds
Pressure Ulcers
Sloughy Wounds
Surgical Wounds
Traumatic Wounds
Venous Ulcers

Mode of Use/Application

Select appropriate size product. Cut to fit and fenestrate or mesh if desired. Hydrate with saline if desired. Affix with sutures, staples, or wound closure strips. Cover with non-adherent dressing to protect Restrata®. Can be used with any type of secondary dressings or NPWT. Reapply weekly or as needed (product typically resorbs in 2 weeks).

Clinically Tested

Latex-friendly
Non-cytotoxic

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