Comparing Wound Complication Following TMA With Aid of Electrospun Fiber Matrix

NCT06063694 | Not Yet Recruiting FDA Device

• 1 other identifier: Single application RCT in TMA
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Transmetatarsal amputation (TMA) patient populations commonly have poor healing outcomes and a large number of complications. There has been little study on the benefits of augmenting a TMA with a synthetic graft substitute. The long term goal is to push for an application of synthetic graft substitute to reduce infection rates and aid in the healing process. Augmenting a TMA with a synthetic electrospun fiber matrix will demonstrate utilization of the product and other comparators in generating wound healing and infection rate outcomes including rate of infection, wound dehiscence and total healing response. Electrospun fiber matrices have long been investigated as an innovative construct for use in tissue engineering and regenerative medicine research due to their ability to mimic the structure and scale of native tissue. Clinical studies have demonstrated clinical efficacy in treating both chronic and acute wounds. There is strong evidence to support the application of a synthetic electrospun fiber matrix will generate favorable wound healing and reduce infection rates.

Conditions

Amputation; Wound; Foot; Wound Complication

Outcome Measures

Primary Outcomes (1)

• Infection rate of transmetatarsal amputation site at 1 week postoperative

  Assessment for signs of infection to transmetatarsal amputation site in both groups at 1 week post-operative follow-up visit. * Assess if patient currently on antibiotics * Amount of wound exudate (none, scant, small, moderate or large) * Type of wound exudate (bloody, serosanguinous, serous, purulent, or foul purulent) * Erythema, edema, and/or increased warmth at surgical site * Presence of fevers or chills * Clinical signs of infection * Photographs taken of the surgical site to document appearance * Wounds measured in centimeters (length, width, depth)

  1 week post-operatively

Secondary Outcomes (3)

• Infection rate of transmetatarsal amputation site at 2, 4 and 12 weeks postoperative

  2, 4 and 12 weeks postoperatively

• Wound dehiscence rate of transmetatarsal amputation site at 12 weeks postoperative

  12 weeks postoperatively

• Wound healing status of transmetatarsal amputation site at 12 weeks postoperative

  12 weeks postoperatively

Study Arms (2)

Transmetatarsal amputation with primary closure

NO INTERVENTION

Transmetatarsal amputation with primary closure and no application of synthetic electrospun fiber matrix.

Transmetatarsal amputation with application of synthetic electrospun fiber matrix

EXPERIMENTAL

Transmetatarsal amputation with application of synthetic electrospun fiber matrix

Device: Synthetic electrospun fiber matrix

Interventions

Synthetic electrospun fiber matrix DEVICE

Electrospun fiber matrices have long been investigated as an innovative construct for use in tissue engineering and regenerative medicine research due to their ability to mimic the structure and scale of native tissue. Clinical studies have demonstrated clinical efficacy in treating both chronic and acute wounds. There is strong evidence to support the application of a synthetic electrospun fiber matrix will generate favorable wound healing and reduce infection rates when used to augment transmetatarsal amputation.

Also known as: Restrata

Transmetatarsal amputation with application of synthetic electrospun fiber matrix

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing TMA
• At least 18 years old
• Adequate perfusion demonstrated by either TcPO2 or ankle-brachial index (ABI) or toe-brachia index (TBI) within 60 days prior to enrollment/randomization (Dorsum TcPO2 of study leg(s) ≥40mmHg OR ABI of study leg(s) with results of ≥ 0.7 and ≤ 1.3 OR TBI of study extremity(ies) with results of ≥ 0.5).
• Patient is willing and capable of complying with all protocol requirements.
• Patient or legally authorized representative (LAR) is willing to provide written informed consent prior to any study procedures

You may not qualify if:

• Previously enrolled into this study or is currently participating in another prospective drug or device study that has not reached its primary endpoint.
• Patient is pregnant, breast feeding or planning to become pregnant.
• Patient has a known allergy to resorbable suture materials.
• Patient has a life expectancy less than three months as assessed by the investigator.
• Patient has received skin substitutes during the run-in period or within 14 days prior to beginning of run-in period.
• Patient currently undergoing cancer treatment.
• Patient diagnosed with autoimmune connective tissue.
• Patient is taking parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during the run-in period or up to 30 days before the run-in period.
• Chronic oral steroid use is not excluded if dose is \<10 mg per day for prednisone.
• Patient unwilling or unable to safely utilize appropriate offloading device to unweight wound(s).

Sponsors & Collaborators

• Scripps Health: lead
• North Park Podiatry: collaborator

Related Publications (3)

• McCallum R, Tagoe M. Transmetatarsal amputation: a case series and review of the literature. J Aging Res. 2012;2012:797218. doi: 10.1155/2012/797218. Epub 2012 Jul 3.

  PMID: 22811912 BACKGROUND

• Alexander J, Desai V, Denden S, Alianello N. Assessment of a Novel Augmented Closure Technique for Surgical Wounds Associated with Transmetatarsal Amputation: A Preliminary Study. J Am Podiatr Med Assoc. 2022 Sep-Oct;112(5):20-256. doi: 10.7547/20-256.

  PMID: 36251595 BACKGROUND

• MacEwan M, Jeng L, Kovacs T, Sallade E. Clinical Application of Bioresorbable, Synthetic, Electrospun Matrix in Wound Healing. Bioengineering (Basel). 2022 Dec 21;10(1):9. doi: 10.3390/bioengineering10010009.

  PMID: 36671580 BACKGROUND

Related Links

• Diabetes and Disability

MeSH Terms

Conditions

Foot Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Trent Brookshier, DPM

  Scripps Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faustine Vuong, DPM

CONTACT

9096881274; vuong.faustine@scrippshealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Group 1: transmetatarsal amputation without augmentation Group 2: transmetatarsal amputation augmentation with synthetic electrospun fiber matrix

Study Record Dates

• First Submitted: September 9, 2023
• First Posted: October 2, 2023
• Study Start: March 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: November 1, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share