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Postoperative Skin Surface Tension Relaxing in Prevention of Facial Surgical Skin Scarring

X

XiaoXi Lin

Status

Completed

Conditions

Scar

Treatments

Device: Tension reduction device

Study type

Interventional

Funder types

Other

Identifiers

NCT03842644
SH9H-2018-T65-2

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of early postoperative skin surface reduction in improving scar formation after facial surgery.

Full description

Primary measurement: the mean scar width calculated by standard photos with rulers.

Secondary measure: the probability of scar hyperplasia.

Enrollment

55 patients

Sex

All

Ages

6 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • The incision is not shorter than 3cm
  • Skin type is III/IV

Exclusion criteria

  • Any medical history of facial surgery, not included injection therapy, external medication or fat graft
  • Unsuitable for device use due to anatomical location of incision, eg. lips, eyelids and ear
  • Patients with a history of keloid or family history of keloid
  • Patients with serious skin disorders, eg. serious psoriasis or dermatitis
  • Patients with severe systemic or congenital disease which may affect the patient's safety in this study

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

55 participants in 2 patient groups

Tension Reduction
Experimental group
Description:
Tension reduction device for 3 months post surgery
Treatment:
Device: Tension reduction device
Control
No Intervention group
Description:
No tension reduction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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