Activated Carbon Interphase Effect on Surgical Incisions vs.Two Common Wound Dressings

NCT04038671 | Withdrawn FDA Device

• 1 other identifier: Liden20191
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

This randomized, prospective study evaluates incision closure, post-surgical wound complications, dressing changes, incision/scar appearance, pain associated with dressing changes, and patient satisfaction rates of an activated carbon dressing versus two commercially available wound dressings.

Conditions

Surgical Wound, Healed

Outcome Measures

Primary Outcomes (1)

• Incision Closure

  Complete re-epithelialization with no drainage

  4 weeks

Secondary Outcomes (7)

• Post-Surgical Wound Complications

  8 weeks

• Incision Scar Appearance

  8 weeks

• Number of Dressing Changes

  8 weeks

• Wound odor

  8 weeks

• Pain with Dressing Changes

  8 weeks

Study Arms (3)

Activated Carbon Dressing

EXPERIMENTAL

A low-adherent, comprised of 100% pure activated carbon and also conforms to body contours to maintain contact with the incision surface. The dressing may be used either dry or moistened with sterilized water over dry or discharging, partial and full thickness wounds.

Device: Activated Carbon Cloth Dressing

Knitted Cellulose Acetate Mesh

ACTIVE COMPARATOR

a non-adhering dressing, comprised of a knitted cellulose acetate mesh impregnated with a specially-formulated petrolatum emulsion.

Device: Knitted Cellulose Acetate Mesh

Antimicrobial Alginate Dressing with Silver

ACTIVE COMPARATOR

a non-adherent antimicrobial alginate dressing with silver

Device: Antimicrobial Alginate Dressing with Silver

Interventions

Activated Carbon Cloth Dressing DEVICE

Patients will return for weekly follow-up evaluations the first four weeks following surgery and then will return for a final evaluation eight weeks postoperatively. Incision dressings will be changed by the investigator or the investigator's nursing staff at each weekly visit to assess for incision closure and post-surgical wound complications.

Activated Carbon Dressing

Knitted Cellulose Acetate Mesh DEVICE

Patients will return for weekly follow-up evaluations the first four weeks following surgery and then will return for a final evaluation eight weeks postoperatively. Incision dressings will be changed by the investigator or the investigator's nursing staff at each weekly visit to assess for incision closure and post-surgical wound complications.

Knitted Cellulose Acetate Mesh

Antimicrobial Alginate Dressing with Silver DEVICE

Patients will return for weekly follow-up evaluations the first four weeks following surgery and then will return for a final evaluation eight weeks postoperatively. Incision dressings will be changed by the investigator or the investigator's nursing staff at each weekly visit to assess for incision closure and post-surgical wound complications.

Antimicrobial Alginate Dressing with Silver

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are at least 18 years of age.
• Patients of both genders and all races.
• Patients undergoing primary, uni- or bilateral operative procedures of the forefoot, midfoot, non-heel posterior foot, ankle, and lower extremity and whose incisions are linear and at least 2 inches in length.
• Patients who are in good general health.
• Patients with no systemic or local active dermatologic disease, such as, but not limited to eczema, psoriasis, skin cancer, scleroderma, or chronic urticaria.
• Patients who have voluntarily signed the informed consent form, including HIPAA Authorization.

You may not qualify if:

• Patients who are younger than 18 years of age.
• Patients undergoing operative procedures involving the heel or whose incisions are non-linear, such as those with curved arches or "S" configurations, and/or are less than 2 inches in length.
• Patients with previous operative procedure around the same area or joint.
• Patients with systemic or local active dermatologic disease, such as but limited to eczema, psoriasis, skin cancer, scleroderma, or chronic urticaria, that might interfere with surgical site evaluation.
• Patients with history of previous local infection.
• Patients with autoimmune conditions.
• Patients with known allergies or topical hypersensitivities to silver or any other components of the study dressings.
• Patients currently taking steroids or other immune modulators know to affect wound healing.
• Patients with vascular disorders that are non-interventional.
• Patients with diabetes who have ankle brachial index measurements less than 0.6 or lower extremities that are non-interventional or by-passable.
• Patients who are considered by the investigator for any reason to be an unsuitable candidate.
• Patients who are unwilling or unable to follow the follow-up evaluation schedules.
• Patients who refuse to voluntarily sign the informed consent form.

Sponsors & Collaborators

• Brock Liden, DPM: lead

Study Sites (2)

Circleville Foot & Ankle, LLC

Circleville, Ohio, 43113, United States

Location

Hocking Valley Community Hospital

Logan, Ohio, 43138, United States

Location

Related Publications (8)

• Chen KK, Elbuluk AM, Vigdorchik JM, Long WJ, Schwarzkopf R. The effect of wound dressings on infection following total joint arthroplasty. Arthroplast Today. 2017 Jul 3;4(1):125-129. doi: 10.1016/j.artd.2017.03.002. eCollection 2018 Mar.

  PMID: 29560407 BACKGROUND

• Collins A. Does the postoperative dressing regime affect wound healing after hip or knee arthroplasty? J Wound Care. 2011 Jan;20(1):11-6. doi: 10.12968/jowc.2011.20.1.11.

  PMID: 21278635 BACKGROUND

• Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.

  PMID: 15253184 BACKGROUND

• Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003 Sep;4(7):407-14. doi: 10.1016/s1526-5900(03)00716-8.

  PMID: 14622683 BACKGROUND

• Kalinski CK, Schnepf M, Laboy D, HernandezL, Nusbaum J, McGrinder B, Comfort C, Alvarez OM. Effectiveness of a Topical Formulation Containing Metronidazole for Wound Odor and Exudate Control. Wounds. 2005;17(4):84-90.

  BACKGROUND

• Langlois J, Zaoui A, Ozil C, Courpied JP, Anract P, Hamadouche M. Randomized controlled trial of conventional versus modern surgical dressings following primary total hip and knee replacement. Int Orthop. 2015 Jul;39(7):1315-9. doi: 10.1007/s00264-015-2726-6. Epub 2015 Mar 19.

  PMID: 25787680 BACKGROUND

• Springer BD, Beaver WB, Griffin WL, Mason JB, Odum SM. Role of Surgical Dressings in Total Joint Arthroplasty: A Randomized Controlled Trial. Am J Orthop (Belle Mead NJ). 2015 Sep;44(9):415-20.

  PMID: 26372751 BACKGROUND

• Tustanowski J. Effect of dressing choice on outcomes after hip and knee arthroplasty: a literature review. J Wound Care. 2009 Nov;18(11):449-50, 452, 454, passim. doi: 10.12968/jowc.2009.18.11.44985.

  PMID: 19901873 BACKGROUND

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

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

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: July 31, 2019
• Study Start: January 7, 2019
• Primary Completion: January 1, 2020
• Study Completion: February 1, 2020
• Last Updated: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)