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Layer-by-layer Collagen Deposition in Microfluidic Devices for Microtissue Stabilization
Published on: September 29, 2015
The safety of reusing injectable collagen: a multicenter microbiological study
P J Culligan1, S Koduri, M H Heit
1University of Louisville Health Sciences Center, Department of Obstetrics, Gynecology, and Women's Health, Louisville, Kentucky 40202, USA. pculligan@louisville.edu
Abstract:
We have previously reported pilot data regarding the safety of saving partially used syringes of a glutaraldehyde cross-linked collagen for use in subsequent treatment sessions with the same individual. That single institution study involved 56 partially used syringes cultured for aerobic bacteria. Only one weakly positive culture was detected among these 56 samples, which prompted us to carry out this expanded study involving multiple centers and different injection techniques. Samples were collected from four centers. Following periurethral injection in an office setting, 166 partially used syringes of glutaraldehyde cross-linked collagen were refrigerated for between 1 and 104 weeks (average 58). Material from all 166 syringes was then cultured qualitatively and quantitatively for both aerobic and anaerobic organisms. Collagen from one syringe grew >100,000 colonies of Escherichia coli. All other cultures were negative. In the pilot study, one culture of 56 syringes was weakly positive for coagulase-negative staphylococcus. When the results from both studies were considered together, only two of 222 partially used syringes (0.9%) were contaminated. The background risk of local infection associated with periurethral collagen injection is approximately 0.29%. Using the statistical equation 'number needed to harm', we found that a clinician would have to reuse 111 syringes at a saving of $34,965 before he or she would cause a single local injection by so doing. Therefore, we feel that it may be cost-effective and safe to reinject material from a partially used syringe of glutaraldehyde cross-linked collagen during a subsequent treatment session on an individual.
Insights
Saving partially used glutaraldehyde cross-linked collagen syringes for reuse in the same patient is safe and cost-effective. Contamination rates were very low (0.9%), with minimal risk of infection compared to the cost savings.
Area of Science:
- Urology
- Biomaterials Science
Background:
- Previous pilot data suggested safety in reusing glutaraldehyde cross-linked collagen.
- A single-center study found low bacterial contamination in saved syringes.
Purpose of the Study:
- To expand on pilot data and assess the safety and cost-effectiveness of reusing partially used syringes of glutaraldehyde cross-linked collagen.
- To evaluate microbial contamination in syringes across multiple centers and injection techniques.
Main Methods:
- Collected 166 partially used syringes of glutaraldehyde cross-linked collagen from four centers after periurethral injection.
- Refrigerated syringes for 1-104 weeks (average 58 weeks).
- Cultured syringe material for aerobic and anaerobic organisms, both qualitatively and quantitatively.
Main Results:
- Only two of 222 total syringes (pilot + expanded study) showed contamination (0.9%).
- One syringe grew over 100,000 colonies of Escherichia coli; another had a weak positive for coagulase-negative staphylococcus.
- Calculated 'number needed to harm' indicated significant cost savings before causing infection.
Conclusions:
- Reinjecting glutaraldehyde cross-linked collagen from partially used syringes may be safe and cost-effective for individual patients.
- The risk of infection from reusing syringes is minimal compared to the potential cost savings.

