Wound HealingNCT01769144
Acticoat Absorbent and BCT Antimicrobial for STSG Donor Site on Thigh
A study testing Acticoat Absorbent and BCT in people with Wound Healing and Wound Infection, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial summary
This study aims to compare the effectiveness of two wound dressings, Acticoat Absorbent (AA) and BCT Antimicrobial (BCT) on Split Thickness Skin Graft (STSG) donor site. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Wound Healing, Wound Infection, Pain
- What is being tested?
- Acticoat Absorbent and BCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2013to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who need STSG, longer than 8 cm and wider than 5 cm, from their thighs
Who cannot join
- systemic steroid
- old scar on thigh
- systemic infection
- anticipated use of antibiotics for more than 24 hours after operation
- pregnancy
- previous chemotherapy within 3 months before operation
Show all 15Show fewer
- anticipated chemotherapy within 3 months after operation
- not over 20 years old
- non-communicable
- burn area more than 20% total body surface area
- systemic auto-immune disease
- liver cirrhosis
- allergy to carbon fiber or alginate
- anticipated MRI study
- dry wound
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362
Kuei-Chang Hsu, MD
Kuei-Chang Hsu, MD
About this study
Official title: Acticoat Absorbent and BCT Antimicrobial for STSG Donor Site on Thigh---A Randomised Controlled Trial
This study aims to compare the effectiveness of two wound dressings, Acticoat Absorbent (AA) and BCT Antimicrobial (BCT) on Split Thickness Skin Graft (STSG) donor site.
Read the detailed description
Seventy patients who undergo STSG procedure in Kaohsiung Veterans General Hospital will be recruited. Two donor sites of equal lengths and widths on the same thigh, which are at least 2 cm apart will be covered randomly with AA and BCT each. Wound healing rate and infection rate will be assessed at 7 and 14 days after surgery. Degrees of pain and itchiness will be assessed daily with Visual Analogue Scale for the first 7 post-operative days. Scar appearance will be assessed with Vancouver Scar Scale 1, 3 and 6 months post-operatively.
- Conditions
- Wound Healing, Wound Infection, Pain, Pruritus, Cicatrix
- Being tested
- Acticoat Absorbent, BCT
- Keywords
- wound healing, wound infection, pain, pruritus, cicatrix, dressings, acticoat absorbent, BCT, KoCarbonAg
- Medical subject headings
- Wound Infection, Pain, Pruritus, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acticoat AbsorbentDevice
wound dressing
BCTDevice
Also called KoCarbonAg
wound dressing
| Study group | Role | What they receive |
|---|---|---|
| Acticoat Absorbent | Active comparator | Acticoat Absorbent wound dressing Receives: Device: Acticoat Absorbent |
| BCT wound dressing | Experimental | wound dressing Receives: Device: BCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound healing rate
percentage of wound area that has healed at this time
Measured: 7 days
wound infection rate
Measured: 7 days
wound healing rate
percentage of wound area that has healed at this time
Measured: 14 days
Secondary outcomes (10)
scar appearance
Measured: 1 month
pain and itchiness
Measured: 1day
scar appearance
Measured: 3 months
scar appearance
Measured: 6 months
pain and itchiness
Measured: 2 days
pain and itchiness
Measured: 3 days
pain and itchiness
Measured: 4 days
pain and itchiness
Measured: 5 days
pain and itchiness
Measured: 6 days
pain and itchiness
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2013 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Collaborators
- Bio-medical Carbon Technology Co., Ltd.
- Responsible party
- Principal investigator, Kuei-Chang Hsu, Kaohsiung Veterans General Hospital.
- Investigators
- Kuei-Chang Hsu, MD, Principal investigator, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769144
- Sponsor's protocol ID
- VGHKS12-CT9-09
- Status last verified
- Jan 2013
- First submitted
- 10 Jan 2013
- Last updated
- 21 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Klasen HJ. Historical review of the use of silver in the treatment of burns. I. Early uses. Burns. 2000 Mar;26(2):117-30. doi: 10.1016/s0305-4179(99)00108-4. No abstract available.
PubMed 10716354Trop M, Novak M, Rodl S, Hellbom B, Kroell W, Goessler W. Silver-coated dressing acticoat caused raised liver enzymes and argyria-like symptoms in burn patient. J Trauma. 2006 Mar;60(3):648-52. doi: 10.1097/01.ta.0000208126.22089.b6.
PubMed 16531870Vlachou E, Chipp E, Shale E, Wilson YT, Papini R, Moiemen NS. The safety of nanocrystalline silver dressings on burns: a study of systemic silver absorption. Burns. 2007 Dec;33(8):979-85. doi: 10.1016/j.burns.2007.07.014. Epub 2007 Oct 23.
PubMed 17959313Tredget EE, Shankowsky HA, Groeneveld A, Burrell R. A matched-pair, randomized study evaluating the efficacy and safety of Acticoat silver-coated dressing for the treatment of burn wounds. J Burn Care Rehabil. 1998 Nov-Dec;19(6):531-7. doi: 10.1097/00004630-199811000-00013.
PubMed 9848045Argirova M, Hadjiski O, Victorova A. Acticoat versus Allevyn as a split-thickness skin graft donor-site dressing: a prospective comparative study. Ann Plast Surg. 2007 Oct;59(4):415-22. doi: 10.1097/SAP.0b013e3180312705.
PubMed 17901734Innes ME, Umraw N, Fish JS, Gomez M, Cartotto RC. The use of silver coated dressings on donor site wounds: a prospective, controlled matched pair study. Burns. 2001 Sep;27(6):621-7. doi: 10.1016/s0305-4179(01)00015-8.
PubMed 11525858Huang Y, Li X, Liao Z, Zhang G, Liu Q, Tang J, Peng Y, Liu X, Luo Q. A randomized comparative trial between Acticoat and SD-Ag in the treatment of residual burn wounds, including safety analysis. Burns. 2007 Mar;33(2):161-6. doi: 10.1016/j.burns.2006.06.020. Epub 2006 Dec 18.
PubMed 17175106Moiemen NS, Shale E, Drysdale KJ, Smith G, Wilson YT, Papini R. Acticoat dressings and major burns: systemic silver absorption. Burns. 2011 Feb;37(1):27-35. doi: 10.1016/j.burns.2010.09.006. Epub 2010 Oct 18.
PubMed 20961690
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acticoat Absorbent and BCT Antimicrobial for STSG Donor Site on Thigh---A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01769144
- Acronym / sponsor ID
- VGHKS12-CT9-09
- Conditions
- Wound Healing, Wound Infection, Pain, Pruritus, Cicatrix
- Keywords
- wound healing, wound infection, pain, pruritus, cicatrix, dressings, acticoat absorbent, BCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Collaborators
- Bio-medical Carbon Technology Co., Ltd.
- Study start
- Jan 2013
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 16 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the effectiveness of two wound dressings, Acticoat Absorbent (AA) and BCT Antimicrobial (BCT) on Split Thickness Skin Graft (STSG) donor site.
Detailed description
Seventy patients who undergo STSG procedure in Kaohsiung Veterans General Hospital will be recruited. Two donor sites of equal lengths and widths on the same thigh, which are at least 2 cm apart will be covered randomly with AA and BCT each. Wound healing rate and infection rate will be assessed at 7 and 14 days after surgery. Degrees of pain and itchiness will be assessed daily with Visual Analogue Scale for the first 7 post-operative days. Scar appearance will be assessed with Vancouver Scar Scale 1, 3 and 6 months post-operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acticoat Absorbent | Active comparator | Device: Acticoat AbsorbentActicoat Absorbent wound dressing |
| BCT wound dressing | Experimental | Device: BCTwound dressing |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who need STSG, longer than 8 cm and wider than 5 cm, from their thighs
Key exclusion criteria (15 listed)
- systemic steroid
- old scar on thigh
- systemic infection
- anticipated use of antibiotics for more than 24 hours after operation
- pregnancy
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 |
|---|---|---|
| Acticoat Absorbentwound dressing | Device | Acticoat Absorbent |
| BCTAlso: KoCarbonAgwound dressing | Device | BCT wound dressing |
Primary outcome
wound healing rate
Time frame: 7 days
percentage of wound area that has healed at this time
wound infection rate
Time frame: 7 days
wound healing rate
Time frame: 14 days
percentage of wound area that has healed at this time
10 secondary outcomes
scar appearance
Time frame: 1 month
pain and itchiness
Time frame: 1day
scar appearance
Time frame: 3 months
scar appearance
Time frame: 6 months
pain and itchiness
Time frame: 2 days
pain and itchiness
Time frame: 3 days
pain and itchiness
Time frame: 4 days
pain and itchiness
Time frame: 5 days
pain and itchiness
Time frame: 6 days
pain and itchiness
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2013.
- Background: PubMed 10716354Klasen HJ. Historical review of the use of silver in the treatment of burns. I. Early uses. Burns. 2000 Mar;26(2):117-30. doi: 10.1016/s0305-4179(99)00108-4. No abstract available.
- Background: PubMed 16531870Trop M, Novak M, Rodl S, Hellbom B, Kroell W, Goessler W. Silver-coated dressing acticoat caused raised liver enzymes and argyria-like symptoms in burn patient. J Trauma. 2006 Mar;60(3):648-52. doi: 10.1097/01.ta.0000208126.22089.b6.
- Background: PubMed 17959313Vlachou E, Chipp E, Shale E, Wilson YT, Papini R, Moiemen NS. The safety of nanocrystalline silver dressings on burns: a study of systemic silver absorption. Burns. 2007 Dec;33(8):979-85. doi: 10.1016/j.burns.2007.07.014. Epub 2007 Oct 23.
- Results publication: PubMed 9848045Tredget EE, Shankowsky HA, Groeneveld A, Burrell R. A matched-pair, randomized study evaluating the efficacy and safety of Acticoat silver-coated dressing for the treatment of burn wounds. J Burn Care Rehabil. 1998 Nov-Dec;19(6):531-7. doi: 10.1097/00004630-199811000-00013.
- Results publication: PubMed 17901734Argirova M, Hadjiski O, Victorova A. Acticoat versus Allevyn as a split-thickness skin graft donor-site dressing: a prospective comparative study. Ann Plast Surg. 2007 Oct;59(4):415-22. doi: 10.1097/SAP.0b013e3180312705.
- Results publication: PubMed 11525858Innes ME, Umraw N, Fish JS, Gomez M, Cartotto RC. The use of silver coated dressings on donor site wounds: a prospective, controlled matched pair study. Burns. 2001 Sep;27(6):621-7. doi: 10.1016/s0305-4179(01)00015-8.
- Results publication: PubMed 17175106Huang Y, Li X, Liao Z, Zhang G, Liu Q, Tang J, Peng Y, Liu X, Luo Q. A randomized comparative trial between Acticoat and SD-Ag in the treatment of residual burn wounds, including safety analysis. Burns. 2007 Mar;33(2):161-6. doi: 10.1016/j.burns.2006.06.020. Epub 2006 Dec 18.
- Results publication: PubMed 20961690Moiemen NS, Shale E, Drysdale KJ, Smith G, Wilson YT, Papini R. Acticoat dressings and major burns: systemic silver absorption. Burns. 2011 Feb;37(1):27-35. doi: 10.1016/j.burns.2010.09.006. Epub 2010 Oct 18.
- Kaohsiung Veterans General HospitalLink provided by the sponsor.
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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.
Kuei-Chang Hsu, MD principal investigator
Kaohsiung Veterans General Hospital.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acticoat Absorbent and BCT in people with Wound Healing and Wound Infection, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
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 1 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 21 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kuei-Chang Hsu, MD (+886-7-3422121 ext. 3073, kchsu@vghks.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound healing rate (time frame: 7 days). The study lists 3 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 NCT01769144, which also lists 8 linked publications.
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 21 Feb 2013.