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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?

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN58295774
Enrollment
24
Registered
2021-02-08
Start date
2021-02-11
Completion date
Unknown
Last updated
2021-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Split skin grafting Surgery

Interventions

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 se
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. Asse

Sponsors

University Kebangsaan Malaysia Medical Centre
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. All patients undergoing split skin grafting using the thigh as a donor site 2. Consented patients

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Pain measured using Visual Analogue Scale (VAS) at rest and dressing removal at baseline, and postoperative days 1-7, 10, 15 and 20

Secondary

MeasureTime frame
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

Countries

Malaysia

Contacts

Public ContactHani Atiqah Saim
dr.ishamuddin.hctm@ukm.edu.my+60 (0)173731025

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026