Acticoat Absorbent and BCT Antimicrobial for STSG Donor Site on Thigh

Pain Clinical Trial

Official title:

Acticoat Absorbent and BCT Antimicrobial for STSG Donor Site on Thigh---A Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01769144
• Other study ID #: VGHKS12-CT9-09
• Status: Recruiting
• Phase: N/A
• First received: January 10, 2013
• Last updated: February 20, 2013
• Start date: January 2013
• Est. completion date: April 2014

Study information

• Verified date: January 2013
• Source: Kaohsiung Veterans General Hospital.
• Contact: Kuei-Chang Hsu, MD
• Phone: +886-7-3422121
• Email: kchsu[@]vghks.gov.tw
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• patients who need STSG, longer than 8 cm and wider than 5 cm, from their thighs

Exclusion Criteria:

• 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

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cicatrix
• Pain
• Pruritus
• Wound Healing
• Wound Infection

Intervention

Device:
• Acticoat Absorbent
wound dressing
• BCT
wound dressing

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.	Bio-medical Carbon Technology Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

References & Publications (8)

Argirova 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. — View Citation

Huang 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. Epub 2006 Dec 18. — View Citation

Innes 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. — View Citation

Klasen HJ. Historical review of the use of silver in the treatment of burns. I. Early uses. Burns. 2000 Mar;26(2):117-30. — View Citation

Moiemen 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. — View Citation

Tredget 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. — View Citation

Trop 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. — View Citation

Vlachou 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. Epub 2007 Oct 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wound healing rate	percentage of wound area that has healed at this time	7 days	No
Primary	wound infection rate		7 days	Yes
Primary	wound healing rate	percentage of wound area that has healed at this time	14 days	No
Secondary	scar appearance		1 month	No
Secondary	pain and itchiness		1day	No
Secondary	scar appearance		3 months	No
Secondary	scar appearance		6 months	No
Secondary	pain and itchiness		2 days	No
Secondary	pain and itchiness		3 days	No
Secondary	pain and itchiness		4 days	No
Secondary	pain and itchiness		5 days	No
Secondary	pain and itchiness		6 days	No
Secondary	pain and itchiness		7 days	No

External Links

•   Kaohsiung Veterans General Hospital