Debridement options for the treatment of the forearm and hand partial thickness dermal burns
| ISRCTN | ISRCTN84005357 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84005357 |
| Secondary identifying numbers | FMAN-01 |
- Submission date
- 12/12/2016
- Registration date
- 16/12/2016
- Last edited
- 16/12/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
Debridement is the medical removal of dead, damaged, or infected tissue to improve the healing potential of the remaining healthy tissue. Many studies show that debridement is essential for the proper wound healing process. Leaving necrosis (dead tissue) and debris in the wound can lead to the wound not healing and becoming chronic. Many studies demonstrate the advantage of early surgical debridement and grafting (transplantation of skin). Surgical removal of dead tissue of partial thickness burns, especially in the forearm and hand regions, should be performed extremely carefully. Moreover, surgery reduces the chances of the burn wound healing itself (self-epithelialization) and has a high risk of serious complications (massive bleeding, damage to blood vessels and nerves). The aim of this study is to compare non-surgical debridement methods for the treatment of forearm and hand partial thickness burns.
Who can participate?
Patients aged from 18 to 65 with forearm and hand deep dermal partial thickness burns (a burn that affects the top two layers of skin)
What does the study involve?
Participants are randomly allocated into four groups. The first group receives standard treatment with gauze dressings with silver sulfadiazine ointment. The second group is treated with hydrocolloid dressings which promotes the shedding of dead tissues (autolytic debridement). The third group is treated with dressings with silver sulfadiazine cream and mechanical debridement (physically removing dead tissue) with special single-use pads. The fourth group is treated with an enzyme gel on gauze dressings to remove dead tissue (enzymatic debridement). The duration of all treatments is three weeks (21 days). An assessment is organized after six months to assess scarring.
What are the possible benefits and risks of participating?
Participants receive modern non-surgical treatment methods that are less painful and more convenient. Some burn wounds could heal after three weeks. Burn wounds which take longer than 21 days to heal may scar.
Where is the study run from?
Lithuanian University of Health Sciences Kaunas Clinics (Lithuania)
When is the study starting and how long is it expected to run for?
April 2014 to February 2017
Who is funding the study?
Biocentras (Lithuania)
Who is the main contact?
Ernest Zacharevskij
ernest.zacharevskij@gmail.com
Contact information
Scientific
Eiveniu str. 2
Kaunas
LT-50009
Lithuania
 ORCID ID |
0000-0002-7827-1041 |
|---|---|
| Phone | +370 (0)657 74889 |
| ernest.zacharevskij@gmail.com |
Study information
| Study design | Randomized controlled parallel-group single-center clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Comparison of enzymatic, mechanical and autolytic debridement methods efficiencies for the treatment of the forearm and hand deep dermal burns |
| Study acronym | EMANAM (Enzymatic, Mechanical and Autolytic Necrectomy for Ambustum Manus) |
| Study objectives | To compare enzymatic, mechanical and autolytic debridement methods for treatment of the forearm and hand deep dermal partial thickness burns. |
| Ethics approval(s) | Kaunas regional biomedical research ethics committee, 07/01/2014 |
| Health condition(s) or problem(s) studied | Forearm and hand deep dermal partial thickness burns |
| Intervention | Participants are randomised into four treatment groups: 1. Standard treatment – gauze dressings with silver sulfadiazine (SSD) 1% ointment (Sulfargin, Grindeks AS, LV) applied once daily on burn wounds 2. Hydrocolloid dressings (GranuFlex®, ConvaTec, USA) changed every 3 days which promote autolytic debridement 3. Dressings with silver sulfadiazine 1% cream once daily and mechanical debridement with special single-use pad of monofilament polyester fibers (Debrisoft, Lohmann & Rauscher GmbH & Co, G,A) for the first four to five days once daily 4. Proteolytic enzyme complex gel (Streptomyces flavus 197 Ferment, Biocentras, LTU) on gauze dressings once daily The duration of all treatments was three weeks (21 days). If this process overstepped 21 days, late grafting would be intended to heal residual parts of the wound. An assessment was organized after six months to evaluate post-burn scars. |
| Intervention type | Other |
| Primary outcome measure | Measured at 3, 7, 14 and 21 days post burn: 1. Burn wound size, estimated by covering it with transparent film and counting square centimeters with a ruler 2. Pain, measured with the Visual Analog Scale (VAS) 10 minutes after dressings have been changed 3. Clinical wound conditions: persistence of necrosis, amount of fibrin, granulation tissue, and epithelialization process, evaluated as a percentage from whole wound area by the same physician according to the study protocol measurement parameters 4. Burn wound contamination, assessed using the Levine wound-swabbing technique |
| Secondary outcome measures | Measured at six months follow-up: 1. Quality of post burn scars, assessed using the Vancouver Scar Scale (VSS) 2. Functional recovery, assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure official Lithuanian translation |
| Overall study start date | 01/04/2014 |
| Completion date | 01/02/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 |
| Key inclusion criteria | 1. Patients aged from 18 to 65 2. Non-extensive burns (total body surface area, TBSA <30%) 3. Forearms and hands deep dermal partial thickness burns (2B°, LDI evaluation: 260 - 600PU) 4. Agreed with trial protocol and signed the consent form |
| Key exclusion criteria | 1. Patients with superficial partial thickness and full thickness forearms and hands burns (2Aº, 3º; LDI evaluation: <260PU, >600PU) 2. Patients with known pregnancy (pregnancy test was performed for all female patients) 3. Vulnerable persons (psychiatric diagnosis) |
| Date of first enrolment | 01/04/2014 |
| Date of final enrolment | 01/08/2016 |
Locations
Countries of recruitment
- Lithuania
Study participating centre
Eiveniu st. 2
Kaunas
LT-50009
Lithuania
Sponsor information
Industry
Graiciuno str. 10
Vilnius
LT-02241
Lithuania
| Phone | +370 (0)670 30004 |
|---|---|
| biocentras@biocentras.lt | |
| Website | www.biocentras.lt |
"ROR" |
https://ror.org/005gk6w44 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/03/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan | The datasets generated and/or analysed during the current study are available from Ernest Zacharevskij (ernest.zacharevskij@gmail.com) on reasonable request |
