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

February 20, 2020 updated by: Brock Liden, DPM

Activated Carbon Interphase Effect on Surgical Incisions Compared to Two Common Wound Dressings in a Prospective Randomized Control Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Postoperative incision complications and surgical site infections are risks for patients undergoing surgery. While most surgical incisions heal without complications, postoperative complications, such as erythema, blistering, maceration, scarring, necrosis, and infection, interfere with the normal healing process. Preventing such complications must be a priority, as they may contribute to longer recovery times, as well as increased hospital stays, costs, and morbidity.

Ideally, surgical incision dressings should exhibit the following characteristics:

  • promote a moist environment;
  • be absorbent, but transparent so fluid accumulation and other complications may be observed;
  • be permeable;
  • be low adherent to facilitate removal from skin;
  • act as a complete barrier to bacteria and water, but not to moisture vapor; and
  • feature some flexibility to avoid restricted limb movement and postoperative edema in the incision area [Chen et al; Collins].

However, despite advances in wound dressing designs, there is no consensus regarding the ideal surgical incision dressing. One emerging dressing modality exhibits these key characteristics. This novel activated carbon cloth dressing is low-adherent, comprised of 100% pure activated carbon and also conforms to body contours to maintain contact with the incision surface.

This randomized, prospective clinical trial will compare this activated carbon cloth dressing to two other commercially-available wound dressings, including a non-adherent antimicrobial alginate dressing with silver and a non-adhering knitted cellulose acetate mesh dressing soaked in Povidone-iodine. The primary endpoint is incision coaptation/closure. Secondary endpoints include incision/scar appearance, such as inflammation and edema, odor, pain, patient satisfaction, and number of dressing changes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Circleville, Ohio, United States, 43113
        • Circleville Foot & Ankle, LLC
      • Logan, Ohio, United States, 43138
        • Hocking Valley Community Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 with vascular disorders must have been treated surgically to be considered for inclusion.
  • Patients with diabetes must have ankle brachial index measurements greater than 0.6 to be considered for inclusion.
  • Patients who have voluntarily signed the informed consent form, including HIPAA Authorization.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Activated Carbon Dressing
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
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.
Active Comparator: Knitted Cellulose Acetate Mesh
a non-adhering dressing, comprised of a knitted cellulose acetate mesh impregnated with a specially-formulated petrolatum emulsion.
Device: Knitted Cellulose Acetate Mesh
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.
Active Comparator: Antimicrobial Alginate Dressing with Silver
a non-adherent antimicrobial alginate dressing with silver
Device: Antimicrobial Alginate Dressing with Silver
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incision Closure
Time Frame: 4 weeks
Complete re-epithelialization with no drainage
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Post-Surgical Wound Complications
Time Frame: 8 weeks
Presence of post-surgical wound complication(s) will be monitored
8 weeks
Incision Scar Appearance
Time Frame: 8 weeks
Patient & Observer Scar Assessment Scale consists of 2 scales; one that the investigator completes and one that the subject completes. The investigator rates vascularization, pigmentation, thickness relief, and pliability on five 10-point numeric scales, with "normal skin" on the left pole and "worst scar imaginable" on the right pole. Patients rate their scar pain & itching, and scar appearance on six 10-point numeric scales, with "no, no complaints" on the left pole and "yes, worst imaginable" on the right pole. Individual items from both scales are summed with higher scores representing poorer scars and lower scores representing scars more closely resembling normal skin. The total score range of the observer scale component is 5 to 50. The total score range of the patient scale component is 6 to 60. The lowest scores, 5 and 6, respectively, reflect normal skin.
8 weeks
Number of Dressing Changes
Time Frame: 8 weeks
The number of dressing changes will be counted by the investigator or study staff.
8 weeks
Wound odor
Time Frame: 8 weeks
Patients will rate the odor of their wound using a Visual Analog Scale that consists of 10-cm(100-mm) line with the descriptor "no odor" positioned at the left pole and the descriptor "extremely offensive odor" positioned at the right pole. The lowest score, 0, reflects no wound odor, whereas a score of 10cm/100mm indicates extremely offensive wound odor.
8 weeks
Pain with Dressing Changes
Time Frame: 8 weeks
Patients will rate their pain associated with the dressing changes using a Visual Analog Scale, as described by Springer BD et al, Am J Orthopedics, 2015. The Visual Analog Scale consists of a 10-cm (100-mm) line with the descriptor "no pain" positioned at the left pole and the descriptor "worst pain imaginable" positioned at the right pole. The lowest score, 0, reflects no pain, whereas a score of 10/100 indicates worst pain imaginable.
8 weeks
Patient Satisfaction
Time Frame: 8 weeks
Patients will rate their satisfaction of their ability to perform activities of daily living, including ability to perform personal hygiene activities, ability to change clothes, ability to sit comfortably, and ability to sleep comfortably, using a Visual Analog Scales, as described by Springer et al, Am J Orthopedics, 2015. For each of the 4 satisfaction measures, patients will rate their satisfaction on the scale that consists of a 10-cm (100-mm) line, with the descriptor completely unsatisfied" on the left pole and the descriptor "completely satisfied" on the right pole. These 4 satisfaction measures will be averaged for a composite satisfaction measure. An average score of 10/100 would indicate the patient is completely satisfied, whereas an average of 0 would indicate the patient is completely unsatisfied.
8 weeks
Ease of Dressing Changes
Time Frame: 8 weeks
Investigator or study staff will rate the difficulty of the dressing changes using a Visual Analog Scale that consists of 10-cm(100-mm) line with the descriptor "no difficulty" positioned at the left pole and the descriptor "extreme difficulty" positioned at the right pole. The lowest score, 0, reflects no difficulty with dressing changes, whereas a score of 10cm/100mm indicates most difficulty with the dressing changes.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brock Liden, DPM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 7, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Liden20191

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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