Early Postoperative Prevention and Treatment of Median Sternotomy Scars With Botulinum Toxin Type A Injection
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|ClinicalTrials.gov Identifier: NCT02886988|
Recruitment Status : Completed
First Posted : September 1, 2016
Last Update Posted : January 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Scar||Drug: Botulinum toxin type A Drug: normal saline||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Placebo-Controlled, Double-Blind, Prospective Clinical Trial of Botulinum Toxin Type A in Prevention of Hypertrophic Scar Development in Median Sternotomy Wound|
|Study Start Date :||October 2016|
|Actual Primary Completion Date :||December 28, 2017|
|Actual Study Completion Date :||January 22, 2018|
Experimental: Botulinum toxin type A
The entire median sternotomy wound was divided into the upper half and the lower half. Both halves of the wound were randomized to receive treatment with either BTA or 0.9% normal saline.100U Botulinum toxin type A(BTA) will be reconstituted with 2mL of normal saline for a concentration of 50U/mL. 0.1ml(5 units) of BTA will be injected along the wound edges. The injections will be administered within 14 days of median sternotomy with a 30G needle.
Drug: Botulinum toxin type A
50 units of botulinum toxin diluted in 1 ml of normal saline will be administered. 0.1mlof BTA will be injected with a 30G needle.
Placebo Comparator: Normal Saline
The entire median sternotomy wound was divided into the upper half and the lower half. Both halves of the wound were randomized to receive treatment with either BTA or 0.9% normal saline.0.1ml normal saline will be injected along the wound edges.
Drug: normal saline
0.1mlof normal saline will be injected with a 30G needle.
Other Name: NaCl 0.9%
- Vancouver scar scale [ Time Frame: 6 months after Botulinum toxin type A injection ]Vancouver scar scale measures pigmentation, vascularity, pliability and scar height 6 months after received BTA injection.
- Scar width [ Time Frame: 6 months after Botulinum toxin type A injection ]At 6-month follow-up, scar width will be measured by ultrasonography.
- Patient satisfaction [ Time Frame: 6 months after Botulinum toxin type A injection ]At 6-month follow-up, patients were asked to evaluate their overall satisfaction, using a four-point grading scale for each half the scar.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02886988
|Xi'an, Shaanxi, China, 710032|
|Principal Investigator:||Song-Tao Xie||Xijing Hospital|