How effective is ionic silver and chlorhexidine (SiO₂- Ag+ Chlorex) spray on pain and re-epithelialisation rate in donor site wounds for patients undergoing split skin grafting?
| ISRCTN | ISRCTN58295774 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58295774 |
| Secondary identifying numbers | JEP-2020-727 |
- Submission date
- 17/01/2021
- Registration date
- 08/02/2021
- Last edited
- 14/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English Summary
Background and study aims
A split thickness skin graft (SSG) is a thin layer of shaved skin is taken from one area of the body to another area which has lost skin covering to get the wound healed. Although new treatment approaches for burn patients undergoing SSG treatment have made progress, there is still a need for better methods to enhance wound healing and recovery. KAdermin (SiO₂- Ag+ Chlorex) spray is a patented medical device that has gained attention due to its renewable nature, good biocompatibility and excellent physical properties that are of importance for wound healing. The aim of this study is to compare the effectiveness of KAdermin spray on pain and re-epithelialisation (healing) rate in donor site wounds for patients undergoing SSG as compared to a hydrocolloid dressing, which is the common practice for patients undergoing split skin grafting.
Who can participate?
All patients requiring SSG
What does the study involve?
After skin grafting the participants are randomly allocated to be treated with either SiO₂- Ag+ Chlorex spray or a conventional dressing (i.e. the hydrocolloid dressing Syncera Elect Hydro). Pain is measured on days 1-7, 10, 15 and 20 after surgery.
What are the possible benefits and risks of participating?
Participation will help the researchers to evaluate the effectiveness of ionic silver and chlorhexidine (SiO₂- Ag+ Chlorex) spray in the healing of donor site wounds for patients undergoing split skin grafting. The risk of this study is possible adverse effects, such as allergies or infection occurring within the study duration. Affected participants will be discontinued from this study and will be treated accordingly. However, as a step to ensure patient’s safety, a patch test will be conducted on patients to identify those allergic to KAdermin spray.
Where is the study run from?
Hospital Canselor Tuanku Muhriz, UKM Medical Centre (Malaysia)
When is the study starting and how long is it expected to run for?
August 2019 to April 2022
Who is funding the study?
Y.S.P Industries (Malaysia)
Who is the main contact?
Hani Atiqah Saim
hanisaim88@gmail.com
Contact information
Public
82, Jalan Jasa 4, Taman Jasa
Selangor
68100
Malaysia
 ORCID ID |
0000-0002-9024-1523 |
|---|---|
| Phone | +60 (0)173731025 |
| dr.ishamuddin.hctm@ukm.edu.my |
Study information
| Study design | Prospective pilot randomized controlled trial, concealed allocation, assessor and participants blinded |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Effect of ionic silver and chlorhexidine (SiO₂- Ag+ Chlorex) spray on pain and re-epithelialisation rate in donor site wounds for patients undergoing split skin grafting (SSG) - a study protocol |
| Study hypothesis | Current hypothesis as of 14/09/2021: There will be improvement in pain and re-epithelialisation rate of skin graft donor sites when treated with SiO₂- Ag+ Chlorex spray as compared to conventional dressing i.e. hydrocolloid dressing (Syncera Elect Hydro). _____ Previous hypothesis: There will be improvement in pain, re-epithelialisation rate and scarring of skin graft donor sites when treated with SiO₂- Ag+ Chlorex spray as compared to conventional dressing i.e. Duoderm. |
| Ethics approval(s) | Approved 16/12/2020, Research Ethics Committee Universiti Kebangsaan Malaysia (Faculty of Medicine UKM, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur, Malaysia; +60 (0)391455046; sepukm@ukm.edu.my), ref: JEP-2020-727 |
| Condition | Split skin grafting |
| Intervention | Current intervention as of 14/09/2021: After recruitment and baseline testing, patients will be randomly assigned to the KAdermin and Syncera Elect Hydro groups. A random allocation sequence will be produced using a computer-generated randomisation sequence on Microsoft Excel; patients will be numbered and randomised into two groups. The allocation sequence will be sealed in identical opaque envelopes and given to the enrolling assessor upon receipt of patient consent. Assessor and all participants will be blinded. To ensure that the assessor is blinded, the nurse in charge will remove the dressings, take the donor site photo and send it to the assessor. The assessor will have no contact with the patients. Intra-operatively, the donor site will be checked and prepared in a sterile fashion, using an antibacterial solution (i.e. povidone iodine) and will be dried. The donor site will then be measured and marked to ensure that the appropriately sized skin graft is harvested. The control group will be dressed using Syncera Elect Hydro, and the intervention group will be dressed with SiO₂- Ag+ Chlorex spray (KAdermin spray). _____ Previous intervention: Intra-operatively, the donor site will be checked and prepared in a sterile fashion, using an antibacterial solution (i.e. povidone iodine) and will be dried. The donor site will then be measured and marked to ensure that the appropriately sized skin graft is harvested. The control group will be dressed using Duoderm, and the intervention group will be dressed with SiO₂- Ag+ Chlorex spray (KAdermin spray). After recruitment and baseline testing, patients will be randomly assigned to the KAdermin and Duoderm groups. A random allocation sequence will be produced using a computer-generated randomisation sequence on Microsoft Excel; patients will be numbered and randomised into two groups. The allocation sequence will be sealed in identical opaque envelopes and given to the enrolling assessor upon receipt of patient consent. Assessor and all participants will be blinded. To ensure that the assessor is blinded, the nurse in charge will remove the dressings, take the donor site photo and send it to the assessor. The assessor will have no contact with the patients. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Syncera Elect Hydro, SiO₂- Ag+ Chlorex spray (KAdermin spray) |
| Primary outcome measure | Pain measured using Visual Analogue Scale (VAS) at rest and dressing removal at baseline, and postoperative days 1-7, 10, 15 and 20 |
| Secondary outcome measures | Current secondary outcome measures as of 14/09/2021: 1. Re-epithelialisation rate of skin graft donor sites will be evaluated on postoperative days 5, 10, 15 and 20. During the wound assessment, standard photography with the same camera, settings and lighting condition will be carried out. The photographs will be assessed; epithelialisation percentage will be calculated by analysing the photographs of the donor sites using image software (Adobe Photoshop®). 2. Patient satisfaction will be measured with a questionnaire at Day 15 post SSG _____ Previous secondary outcome measures: 1. Re-epithelialisation rate of skin graft donor sites will be evaluated on postoperative days 5, 10, 15 and 20. During the wound assessment, standard photography with the same camera, settings and lighting condition will be carried out. The photographs will be assessed; epithelialisation percentage will be calculated by analysing the photographs of the donor sites using image software (Adobe Photoshop®). 2. Scarring will be assessed with the Vancouver Scar Scale (VSS) and Patient and Observer Scar Assessment Scale (POSAS) at Day 15, 20 and 45 post SSG 3. Patient satisfaction will be measured with a questionnaire at Day 15 post SSG |
| Overall study start date | 03/08/2019 |
| Overall study end date | 09/04/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 12 patients for each arm. Total 24 patients. |
| Participant inclusion criteria | 1. All patients undergoing split skin grafting using the thigh as a donor site 2. Consented patients |
| Participant exclusion criteria | 1. Known allergy to any component of the dressings 2. Uncontrolled diabetes mellitus, as measured by HbA1c ≥10% 3. Presence of active autoimmune or immune diseases 4. Use of systemic steroid or immunosuppressants |
| Recruitment start date | 11/02/2021 |
| Recruitment end date | 09/04/2022 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Bandar Tun Razak
56000
Malaysia
Sponsor information
Hospital/treatment centre
Medical Faculty
Jalan Yaacob Latif
Bandar Tun Razak
56000
Malaysia
| Phone | +60 (0)391455046 |
|---|---|
| sepukm@ukm.edu.my | |
| Website | http://www.ppukm.ukm.my/ |
"ROR" |
https://ror.org/01590nj79 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 09/04/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. The protocol will be available at a later date. |
| IPD sharing plan | The data will be available with the publication of the final manuscript as a supplemental document. |
Editorial Notes
14/09/2021: The following changes have been made:
1. The study hypothesis has been changed.
2. Duoderm has been removed from the drug names and Syncera Elect Hydro added. This has also been updated in the plain English summary.
3. The intervention has been changed.
4. The secondary outcome measures have been changed.
08/02/2021: Trial's existence confirmed by University Kebangsaan Malaysia.
