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NCT03849274
SMART Dressing for Hypertrophic Scar Treatment Post-Total Knee/Hip Arthroplasty
EARLY_PHASE1 trial testing Smart Scar Care Pad=Pressure Garment in Knee Arthropathy in 60 participants. Completed in 31 July 2021.
31 July 2021
Quick facts
| Lead sponsor | Chinese University of Hong Kong |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 31 January 2020 |
| Primary completion | 31 July 2021 |
| Estimated completion | 31 July 2021 |
| Sites | 1 location across Hong Kong |
Drugs / interventions tested
- Smart Scar Care Pad=Pressure Garment
- Pressure Garment
Conditions studied
- Knee Arthropathy — all drugs for Knee Arthropathy →
- Hip Arthropathy — all drugs for Hip Arthropathy →
- Hypertrophic Scar — all drugs for Hypertrophic Scar →
Sponsor
Chinese University of Hong Kong
Who can join
18 and older, any sex, with Knee Arthropathy or Hip Arthropathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Pressure therapy (PT) and silicone therapy are recommended as first-line non-invasive treatment for Hypertrophic Scar (HS), yet the effectiveness of the combination of these two treatments through an RCT trial has not been established yet. This study aims to examine the effectiveness of the combination of adequate pressure therapy and silicone gel sheeting implemented by Smart Scar Care Pad (SSCP) + conventional Pressure Garment (PG) versus conventional Pressure Garment (PG) alone in the management of HS in adult with total hip replacement (THR) and total knee replacement (TKR). This study also aims to find out the prevalence of hypertrophic scar among patients with THR and TKR. This study is a randomised controlled trial with two parallel arms, with allocation ratio (Experimental: Control) of 1: 1 in order to establish the superiority of SSCP + PG over PG. Subjects with hypertrophic scar will be randomly assigned to either treatment or control group. The subjects in the treatment group will be provided with the SSCP and PG for treatment, whereas the subjects in the control group will be prescribed only the PG. The treatment will last for a total of 6 months. A variety of objective outcome measures will be used to analysis the treatment effect.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03849274
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Related trials
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Other Chinese University of Hong Kong trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03849274 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chinese University of Hong Kong
- Last refreshed: 15 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03849274.
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