Intraoperative Hyaluronic Acid Gel Injection for Improvement of Scar Quality Following Reduction Mammaplasty

Intraoperative Hyaluronic Acid Gel Injection for Improvement of Scar Quality Following Reduction Mammaplasty: a Phase III Double-blinded, Single-centred, Randomized Controlled Study

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00958425

Enrollment

Registered

2009-08-13

Start date

2014-01-01

Completion date

2014-01-01

Last updated

2024-08-21

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

Conditions

Cicatrix

Brief summary

The purpose of this study is to determine the efficacy of hyaluronic acid gel injections compared to saline injections in improving scar quality in patients undergoing breast reduction surgery. Hyaluronic acid has been implicated in scarless fetal healing, and the investigators therefore hypothesize that injections of hyaluronic acid gel into breast reduction incisions will improve their appearance compared to injections of saline.

Interventions

DEVICEHyaluronic acid gel

Hyaluronic acid gel (20 mg/mL), 0.9 mL, intradermal over 2 cm area, once

DEVICESaline

Normal saline, 0.9 mL, intradermal over 2 cm area, once

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* adequate organ function (BUN \< 4.0 mmol/L; serum creatinine \< 120 micromol/L; Hgb \> 100 g/L; WBC \> 4,000/mm3 and \< 12,000/mm3; platelets \> 100,000/mm3) * age 18 years or older, with a minimum life expectancy of 2 years * current non-smoker * American Society of Anaesthesiology score of 1 or 2 * ability to provide informed consent

Exclusion criteria

* previous history of breast surgery; known allergy to polyglactin, poliglecaprone, or injectable hyaluronic acid gel (Restylane or Prevelle) * history of current or recent (\<2 months) immunosuppression * documented hypersensitivity to streptococcal products * acute or chronic skin diseases such as folliculitis or psoriasis * history of bleeding dyscrasia or active anticoagulation (INR\>2.0) * pregnancy or active breast-feeding * any additional surgical procedures performed in the same surgical session in the same anatomical region * personal or family history of susceptibility to keloid or hypertrophic scar formation * Fitzpatrick skin type 5 or 6.

Design outcomes

Primary

Measure	Time frame
Rasch analysis-modified Objective Scar Assessment Score (OSAS) value	12 months post-operatively

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026