CicatrixPhase 3NCT00958425
Intraoperative Hyaluronic Acid Gel Injection for Improvement of Scar Quality Following Reduction Mammaplasty
A Phase 3 study testing Hyaluronic acid gel and Saline in people with Cicatrix, run by Nova Scotia Health Authority.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cicatrix
- What is being tested?
- Hyaluronic acid gel and Saline
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Jan 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
About this study
Official title: Intraoperative Hyaluronic Acid Gel Injection for Improvement of Scar Quality Following Reduction Mammaplasty: a Phase III Double-blinded, Single-centred, Randomized Controlled Study
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.
- Conditions
- Cicatrix
- Being tested
- Hyaluronic acid gel, Saline
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid gelDevice
Also called Prevelle, Restylane, Hyalorunan, Hyaluronate
Hyaluronic acid gel (20 mg/mL), 0.9 mL, intradermal over 2 cm area, once
SalineDevice
Also called Normal saline
Normal saline, 0.9 mL, intradermal over 2 cm area, once
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid gel | Experimental | Not described Receives: Device: Hyaluronic acid gel |
| Saline | Active comparator | Not described Receives: Device: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rasch analysis-modified Objective Scar Assessment Score (OSAS) value
Measured: 12 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study start1 Jan 2014 (estimated)
- Primary completion1 Jan 2014 (estimated)
- Study completion1 Jan 2014
Why it stopped: Failure of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CicatrixStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Bezuhly, MD MSc SM FRCSC, Principal investigator, Capital District Health Authority; Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958425
- Sponsor's protocol ID
- CDHA-RS/2009-252
- Status last verified
- Jan 2016
- First submitted
- 11 Aug 2009
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Hyaluronic Acid Gel Injection for Improvement of Scar Quality Following Reduction Mammaplasty: a Phase III Double-blinded, Single-centred, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00958425
- Acronym / sponsor ID
- CDHA-RS/2009-252
- Conditions
- Cicatrix
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Failure of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 1 Jan 2014 (estimated)
- Primary completion
- 1 Jan 2014 (estimated)
- Study completion
- 1 Jan 2014 (actual)
- First posted
- 13 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid gel | Experimental | Device: Hyaluronic acid gel |
| Saline | Active comparator | Device: Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic acid gelAlso: Prevelle, Restylane, Hyalorunan, HyaluronateHyaluronic acid gel (20 mg/mL), 0.9 mL, intradermal over 2 cm area, once | Device | Hyaluronic acid gel |
| SalineAlso: Normal salineNormal saline, 0.9 mL, intradermal over 2 cm area, once | Device | Saline |
Primary outcome
Rasch analysis-modified Objective Scar Assessment Score (OSAS) value
Time frame: 12 months post-operatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
Related trials for Cicatrix
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
RecruitingPhase 2
Tirzepatide for Treatment of CCCA
Central Centrifugal Cicatricial Alopecia (CCCA)
Recruiting
Surgical Outcomes of Simple Interrupted Versus Running Epidermal Sutures in Full-thickness Skin Graft Placement
Skin Graft Scar
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Bezuhly, MD MSc SM FRCSC principal investigator
Capital District Health Authority; Dalhousie University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hyaluronic acid gel and Saline in people with Cicatrix, run by Nova Scotia Health Authority.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rasch analysis-modified Objective Scar Assessment Score (OSAS) value (time frame: 12 months post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.