Acticoat Absorbent and BCT Antimicrobial for STSG Donor Site on Thigh

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.

Study Overview

• Status: Unknown
• Conditions: Pain; Cicatrix; Wound Infection; Pruritus; Wound Healing
• Intervention / Treatment: Device: Acticoat Absorbent; Device: BCT

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 Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kuei-Chang Hsu, MD; Phone Number: 3073 +886-7-3422121; Email: kchsu@vghks.gov.tw

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 81362
    • Recruiting
    • Kaohsiung Veterans General Hospital
    • Contact: Kuei-Chang Hsu, MD
    • Principal Investigator: Kuei-Chang Hsu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Acticoat Absorbent; Acticoat Absorbent wound dressing	Device: Acticoat Absorbent; wound dressing
Experimental: BCT wound dressing; wound dressing	Device: BCT; wound dressing; Other Names: KoCarbonAg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
wound healing rate	percentage of wound area that has healed at this time	7 days
wound infection rate		7 days
wound healing rate	percentage of wound area that has healed at this time	14 days

Secondary Outcome Measures

Outcome Measure	Time Frame
scar appearance	1 month
pain and itchiness	1day
scar appearance	3 months
scar appearance	6 months
pain and itchiness	2 days
pain and itchiness	3 days
pain and itchiness	4 days
pain and itchiness	5 days
pain and itchiness	6 days
pain and itchiness	7 days

Collaborators and Investigators

• Sponsor: Kaohsiung Veterans General Hospital.
• Collaborators: Bio-medical Carbon Technology Co., Ltd.
• Investigators: Principal Investigator: Kuei-Chang Hsu, MD, Kaohsiung Veterans General Hospital.

Publications and helpful links

General 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.
• 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. doi: 10.1097/01.ta.0000208126.22089.b6.
• 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. doi: 10.1016/j.burns.2007.07.014. Epub 2007 Oct 23.
• 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. doi: 10.1097/00004630-199811000-00013.
• 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. doi: 10.1097/SAP.0b013e3180312705.
• 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. doi: 10.1016/s0305-4179(01)00015-8.
• 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. doi: 10.1016/j.burns.2006.06.020. Epub 2006 Dec 18.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): July 1, 2013
• Study Completion (Anticipated): April 1, 2014

Study Registration Dates

• First Submitted: January 10, 2013
• First Submitted That Met QC Criteria: January 14, 2013
• First Posted (Estimate): January 16, 2013

Study Record Updates

• Last Update Posted (Estimate): February 21, 2013
• Last Update Submitted That Met QC Criteria: February 20, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: pain; wound infection; wound healing; pruritus; cicatrix; dressings; acticoat absorbent; BCT; KoCarbonAg
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Infections; Fibrosis; Skin Manifestations; Wounds and Injuries; Pruritus; Cicatrix; Wound Infection
• Other Study ID Numbers: VGHKS12-CT9-09