Adhesive-enhanced sternal closure to improve postoperative functional recovery: a pilot, randomized controlled trial

Area of Science:

• Biomaterials Science
• Surgical Innovation
• Clinical Trials

Background:

• Previous studies demonstrated enhanced mechanical strength and stability using a novel biocompatible bone adhesive with conventional wire cerclage in a cadaveric model.
• This pilot study investigates the clinical efficacy of adhesive-enhanced sternal closure in patients undergoing primary sternotomy.

Purpose of the Study:

• To evaluate the impact of adhesive-enhanced sternal closure on functional postoperative recovery.
• To assess incisional pain, analgesic use, respiratory capacity, physical disability, and health-related quality of life.

Main Methods:

• A single-center, randomized clinical trial involving 55 patients undergoing primary sternotomy.
• Comparison between conventional wire closure (26 patients) and adhesive-enhanced closure using Kryptonite biocompatible adhesive plus wire cerclage (29 patients).
• Postoperative monitoring included pain, analgesic use, maximal inspiratory capacity, physical disability, and quality of life assessments over 12 months.

Main Results:

• Adhesive-enhanced closure showed no adverse events or sternal complications.
• Patients receiving adhesive-enhanced closure reported reduced incisional pain and narcotic analgesic use.
• Significant improvements were observed in inspiratory capacity, faster normalization of quality of life scores, and reduced physical disability.

Conclusions:

• Adhesive-enhanced sternal closure is a safe and effective adjunct to conventional wire closure.
• This technique demonstrates significant benefits in functional recovery, respiratory function, pain management, and analgesic requirements.
• Further large-scale, multicenter trials are recommended to confirm these findings and explore its potential in high-risk patients.