Phase 4
N=64
Tissue Glue (Cyanoacrylate) Versus Conventional Suture in Kidney Donors
Skin Closure of Surgical Incisions by Tissue Glue vs Suture
Bottom Line
View on ClinicalTrials.gov: NCT01521871 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Wound Healing by Numerical Scales for Rubor Postoperative Day 2. — 0.516; 0.984 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Skin wound closure by tissue glue (Procedure); Skin wound closure by conventional suture + dressing (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Oslo University Hospital
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wound Healing by Numerical Scales for Rubor Postoperative Day 2. |
0.516; 0.984 | — |
| PRIMARY Wound Healing by Numerical Scales for Rubor Postoperative Day 4. |
0.547; 0.750 | — |
| PRIMARY Wound Healing by Numerical Scales for Rubor at Discharge From Hospital. |
0.476; 0.639 | — |
| PRIMARY Wound Healing by Numerical Scales for Secretion Postoperative Day 2. |
0.328; 0.594 | — |
| PRIMARY Wound Healing by Numerical Scales for Secretion Postoperative Day 4. |
0.375; 0.117 | — |
| PRIMARY Wound Healing by Numerical Scales for Secretion at Discharge From Hospital. |
0.286; 0.028 | — |
| PRIMARY Wound Healing by Numerical Scales for Oedema Postoperative Day 2. |
0; 0.094 | — |
| PRIMARY Wound Healing by Numerical Scales for Oedema Postoperative Day 4. |
0; 0.083 | — |
| PRIMARY Wound Healing by Numerical Scales for Oedema at Discharge From Hospital. |
0; 0.111 | — |
| PRIMARY Wound Healing by Numerical Scales for Blisters Postoperative Day 2. |
0; 0.156 | — |
| PRIMARY Wound Healing by Numerical Scales for Blisters Postoperative Day 4. |
0; 0.200 | — |
| PRIMARY Wound Healing by Numerical Scales for Blisters at Discharge From Hospital. |
0; 0.028 | — |
| PRIMARY Wound Healing by Numerical Scales for Gaps Postoperative Day 2. |
0.094; 0 | — |
| PRIMARY Wound Healing by Numerical Scales for Gaps Postoperative Day 4. |
0.344; 0 | — |
| PRIMARY Wound Healing by Numerical Scales for Gaps at Discharge From Hospital. |
0.400; 0 | — |
| PRIMARY TIme Consumption |
5.832; 8.594 | — |
| PRIMARY Patients´Self Satisfaction. |
4.968; 4.875 | — |
Summary
By means of a prospective, randomised trial the investigators want to examine skin closure in living donors - subjected to laparoscopic, hand-assisted nephrectomy - by tissue glue (Cyanoacrylate (Liquiband)) versus conventional, intracutaneous suture and dressing (1 : 1; 30 + 30 donors).
Study hypothesis: (i) Latest generation tissue glue (Cyanoacrylate (Liquiband)) is at least as good as conventional suture regarding wound healing/complications. (ii) Peroperatively, tissue glue is faster than conventional suture.
Eligibility Criteria
Inclusion Criteria
- Living kidney donor with informed consent
- Approved comprehensive work-up/evaluation at local hospital
Exclusion Criteria
- Allergy towards acrylate or similar chemicals
- Unable to communicate in norwegian language
Data sourced from ClinicalTrials.gov (NCT01521871). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.