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Completed

NCT Number: NCT02642679

Evaluation of Opticell Ag on Split-Thickness Skin Graft Donor Sites in Adult Subjects

The purpose of this single center, prospective case series is to evaluate the effective management of split-thickness skin graft donor site wounds using Opticell Ag (Chitosan-based dressing).

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Key information

Conditions

Split-thickness Skin Graft Donor Sites

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inpatient status at study site
  • Subject must be receiving a split-thickness skin graft (STSG)
  • Wounds must not exceed 10% total body surface area (TBSA)
  • Any donor site
  • Ability to comply with necessary wound care/follow up

Exclusion criteria

  • Subject is pregnant
  • Subject has been diagnosed with Diabetes
  • Subject is a smoker
  • Subject takes steroids
  • Subject is sensitive and/or allergic to shellfish and/or silver
  • Wounds that exceed 10% total body surface area (TBSA)
  • Inability to comply with necessary wound care/follow up

Treatment and study plan

Opticell Ag

Device

Opticell Ag+ applied to STSG donor site

Other names: Opticell Ag+, Opticell Ag Plus Gelling Fiber with Silver

Primary outcomes

  1. Pain

    Time frame: Assessed up to 14 days of use

    Pain reported by Subject using a visual analog scale (VAS). This scale measures an unidimensional measure of pain intensity by means of a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length. The left side of the scale signifies no pain (score of 0), and the right side the other extreme, worst pain imaginable (score of 10). Patients are asked to place a line perpendicular to the VAS scale at the point that represents their pain intensity.

  2. Wound Healing Rate (Re-epithelialization)

    Time frame: Assessed up to 1 month postoperatively.

    The extent of re-epithelialization was evaluated by the surgeon and a blinded expert using photographs taken on days 10-14 and at 1 month postoperatively.

Secondary outcomes

  1. Wound Healing Quality

    Time frame: Assessed up to 1 month of use

    Assessed using the Vancouver scar scale (VSS) 1-month post-operatively. The VSS is a widely used scale in clinical practice to document change in scar appearance. The scale scores four parameters: pigmentation, vascularity, pliability, and height for a total of 13 points. Normal appearance in each of the parameters garners a score of 0 and scores get higher (2-3) as an increase in parameters is observed. The lower the score, the better the outcome.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Medline Industries

Registry information

Official study title

Evaluation of Opticell Ag (Chitosan Based Dressing) on Split-Thickness Skin Graft (STSG) Donor Sites in Adult Subjects

Acronym: STSG

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 30, 2015
Registry last updated
Dec 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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