Split-thickness Skin Graft Donor SitesSTSGNCT02642679

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

A study testing Opticell Ag in people with Split-thickness Skin Graft Donor Sites, run by Brigham and Women's Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Split-thickness Skin Graft Donor Sites
What is being tested?: Opticell Ag
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: No sites listed yet
Study dates: Jan 2016to Dec 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: Evaluation of Opticell Ag (Chitosan Based Dressing) on Split-Thickness Skin Graft (STSG) 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).

Conditions: Split-thickness Skin Graft Donor Sites
Being tested: Opticell Ag
Keywords: Split-thickness skin graft, donor site, chitosan, dressing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Opticell AgDevice
Also called Opticell Ag+, Opticell Ag Plus Gelling Fiber with Silver
Opticell Ag+ applied to STSG donor site

Study groups in NCT02642679
Study group	Role	What they receive
Opticell Ag	Experimental	Opticell Ag covered with a transparent occlusive dressing (Tegaderm) with evenly distributed perforations which permit a controlled leakage into a layer of cotton gauze pads placed directly over the Opticell Ag and occlusive dressing combination. Receives: Device: Opticell Ag

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain
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.
Measured: Assessed up to 14 days of use
Wound Healing Rate (Re-epithelialization)
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.
Measured: Assessed up to 1 month postoperatively.

Secondary outcomes (1)

Wound Healing Quality
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.
Measured: Assessed up to 1 month of use

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2016Dec 2016

First posted30 Dec 2015 (estimated)
Study startJan 2016
Primary completionOct 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Split-thickness Skin Graft Donor SitesStudies of the same condition, open and under way.
More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Opticell Ag dressing applied to STSG donor site
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02642679
Sponsor's protocol ID: 2015P001975
Acronym: STSG
Status last verified: Nov 2017
First submitted: 22 Dec 2015
Last updated: 8 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Not yet recruiting
Autologous Skin Cell Suspension (RECELL®) for Accelerated Healing of Split-Thickness Skin Graft Donor Sites: A Randomized, Intra-Patient (Split-Site) Controlled Trial
Skin Graft Donor Site, Wound Healing
Active, not recruiting
Allogeneic Adipose Tissue Extract in Wound Treatment and Scar Maturation
Wound Healing
Not yet recruiting
Comparison of Dressing Materials of Donor Site of Split-thickness Skin Graft; Paraffin Mesh Gauze vs Povidone-Iodine Foam at SMBB Institute of Trauma Karachi
Skin Graft Wounds
Recruiting
Aloe Vera vs Paraffin Tulle Dressings for Pain Management in Split Thickness Skin Graft Donor Sites
Skin Graft Wounds, Donor Site Complication

All Split-thickness Skin Graft Donor Sites trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Opticell Ag (Chitosan Based Dressing) on Split-Thickness Skin Graft (STSG) Donor Sites in Adult Subjects
ClinicalTrials.gov ID: NCT02642679
Acronym / sponsor ID: STSG / 2015P001975
Conditions: Split-thickness Skin Graft Donor Sites
Keywords: Split-thickness skin graft, donor site, chitosan, dressing
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Brigham and Women's HospitalUniversity, hospital or other
Collaborators: Medline Industries
Study start: Jan 2016 (actual)
Primary completion: Oct 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 30 Dec 2015 (estimated)
Results: Posted 8 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Opticell Ag dressing applied to STSG donor site

Arm	Type	Receives
Opticell Ag	Experimental	Device: Opticell AgOpticell Ag covered with a transparent occlusive dressing (Tegaderm) with evenly distributed perforations which permit a controlled leakage into a layer of cotton gauze pads placed directly over the Opticell Ag and occlusive dressing combination.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Opticell AgAlso: Opticell Ag+, Opticell Ag Plus Gelling Fiber with SilverOpticell Ag+ applied to STSG donor site	Device	Opticell Ag

Primary outcome

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.
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.

1 secondary outcome

Wound Healing Quality
Time frame: Assessed up to 1 month of use

Results and safety

Results posted to the registry on 8 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Opticell Ag	19	16

Primary outcome: Pain

Time frame: Assessed up to 14 days of use. Mean (Standard Deviation). Unit: units on a scale

Measure	Opticell Ag n = 16
Mean Day 1	4.2 (3.2)
Mean Day 5-7	2.5 (2.2)
Mean Day 10-14	1.1 (1)

Population analysed: Pain was evaluated on postoperative day 1, before the dressing was changed on days 5-7, and before and after dressing removal on days 10-14 using the Visual Analog Scale (VAS). The patient was asked to mark his/her pain level on the line between the two endpoints.

Primary outcome: Wound Healing Rate (Re-epithelialization)

Time frame: Assessed up to 1 month postoperatively.. Mean (Standard Deviation). Unit: percent (%)

Measure	Opticell Ag n = 16
Day 10-14	92.3 (8.9)
1 month	99.5 (1)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected from January to December 2016.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Opticell Ag	0 of 19 (0%)	0 of 19 (0%)	0 of 19

Limitations and caveats (from the sponsor): This pilot study is not a randomized, control study and is limited by the absence of a small sample size and direct comparison group.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Split-thickness Skin Graft Donor Sites

Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Not yet recruiting
Autologous Skin Cell Suspension (RECELL®) for Accelerated Healing of Split-Thickness Skin Graft Donor Sites: A Randomized, Intra-Patient (Split-Site) Controlled Trial
Skin Graft Donor Site, Wound Healing
Active, not recruiting
Allogeneic Adipose Tissue Extract in Wound Treatment and Scar Maturation
Wound Healing
Not yet recruiting
Comparison of Dressing Materials of Donor Site of Split-thickness Skin Graft; Paraffin Mesh Gauze vs Povidone-Iodine Foam at SMBB Institute of Trauma Karachi
Skin Graft Wounds
Recruiting
Aloe Vera vs Paraffin Tulle Dressings for Pain Management in Split Thickness Skin Graft Donor Sites
Skin Graft Wounds, Donor Site Complication

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Indranil Sinha, MD principal investigator

Brigham and Women's Hospital

Questions about this trial

What is this clinical trial studying?

A study testing Opticell Ag in people with Split-thickness Skin Graft Donor Sites, run by Brigham and Women's Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain (time frame: Assessed up to 14 days of use). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02642679.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2017.