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Investigation on the efficacy and safety of applying skin wound tension reduction device in prevention of scalp postsurgical hypertrophic scar

Investigation on the efficacy and safety of applying skin wound tension reduction device in prevention of scalp postsurgical hypertrophic scar: a single center, randomized controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077219
Enrollment
Unknown
Registered
2023-11-01
Start date
2023-11-01
Completion date
Unknown
Last updated
2023-11-06

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

Conditions

Scar

Interventions

Tension reduction group :Skin wound tension reduction device applied postsurgically for 3 months.

Sponsors

Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 3-50, male or female. 2. Patients, who need facial or cervical reconstructive surgery by means of expanded face/neck flap prefabricated by superficial temporal fascia, underwent the first stage surgical procedure of transferring the superficial temporal fascia and implanting the tissue expander. 3. The surrounding area of incision, namely the superficial projection area of superficial temporal fascia, was healthy and untreated. 4. Skin type III/IV according to Fitzpatrick skin types. 5. Patients who were willing to accept and to cooperate with treatment and regular follow-ups.

Exclusion criteria

Exclusion criteria: 1. Patients with diagnosed or suspected keloid, or a family history of keloid. 2. Patients who were diagnosed with severe skin diseases, such as psoriasis, scleroderma, eczema, etc. 3. Patients with comorbidities which could impair wound healing, such as malignant tumors, refractory diabetes, refractory high blood pressure, unstable pneumonia, kidney or liver disease, unstable myocardial ischemic diseases, expansionary myocardial disease, cardiac conduction disorders or unstable cardiovascular disease, etc. 4. Patients who have participated in other clinical trials. 5. Patients with severe psychopathy or mental retardation who were unable to apply the skin wound tension reduction device for a long term.

Design outcomes

Primary

MeasureTime frame
Width of scar;

Secondary

MeasureTime frame
Patient and Observer Scar Assessment Scale (POSAS) Score;Incidence of Hypertrophy Scar;

Countries

China

Contacts

Public ContactYajing Qiu

Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University, School of Medicine

199058321@qq.com+86 177 0169 0005

Outcome results

None listed

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