Trial · NCT00600483
Safety and Efficacy of an Antibiotic Implant in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Infection
NCT00600483, Phase 3, Completed, Innocoll; results first posted 2022-05-05
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Safety and Efficacy of an Antibiotic Implant in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Infection. Trials, record NCT00600483. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00600483
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of an Antibiotic Implant in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Infection
- NCT number
- NCT00600483
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,502 participants, actual
- Lead sponsor
- Innocoll
- Conditions
- Cardiac Surgery, Sternal Wound Infection
- Interventions
- gentamicin-collagen sponge dipped in saline
- First posted
- 2008-01-25
- Last updated
- 2022-05-05
- Results first posted
- 2022-05-05
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Surgical Wound Infections From Surgery Through Post-operative Day 90 | 90 days post cardiac surgery | Efficacy will be evaluated by a comparison between the 2 study groups of the incidence of surgical wound infections that occur within the period from surgery through postop day 90. |
| Secondary | Surgically Treated Surgical Wound Infection Postoperative Day 90 | 90 days post cardiac surgery | Proportion of patients with surgically treated surgical wound infection adjudicated by an independent blinded committee. |
| Secondary | Proportion of Patients With Deep Surgical Wound Infections Based on Centers for Disease Control Criteria Adjudicated by an Independent Blinded Committee. | 90 days post cardiac surgery | |
| Secondary | Proportion of Patients With Superficial Surgical Wound Infections Based on Centers for Disease Control Criteria Adjudicated by an Independent Blinded Committee. | 90 days post cardiac surgery | |
| Secondary | Number of Participants Positive for Each Pathogen Culture | 90 days post cardiac surgery | Analysis associated with Microbial Pathogens in Adjudicated 90 Day SWI Subjects ME within Per Protocol Population. Any Microbial Pathogens Detected in SWI (ME) |
| Secondary | ASEPSIS Score | 90 days post cardiac surgery | ASEPSIS Score through 90 days postoperative - To compare antibiotic regimens for their effectiveness in preventing or treating wound sepsis, well-defined criteria for outcome are needed. A method of assessing wound healing has been devised that defines carefully the characteristics to be considered and how they are to be awarded points. Objective criteria are also included in the assessment. Points are given for the need for Additional treatment, the presence of Serous discharge, Erythema, Purulent exudate, and Separation of the deep tissues, the Isolation of bacteria, and the duration of inpatient Stay (ASEPSIS). The higher the points the worse outcome. Maximum Points would be 60. Minimum points would be 0 |
| Secondary | Rehospitalization for Sternal Wound Infection | 90 days post cardiac surgery | Rehospitalization for Sternal Wound Infection - within 90 days postoperatively. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Surgical Wound Infections From Surgery Through Post-operative Day 90 | 90 days post cardiac surgery | ITT population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Surgically Treated Surgical Wound Infection Postoperative Day 90 | 90 days post cardiac surgery | ITT Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients With Deep Surgical Wound Infections Based on Centers for Disease Control Criteria Adjudicated by an Independent Blinded Committee. | 90 days post cardiac surgery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Patients With Superficial Surgical Wound Infections Based on Centers for Disease Control Criteria Adjudicated by an Independent Blinded Committee. | 90 days post cardiac surgery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Positive for Each Pathogen Culture | 90 days post cardiac surgery | PP Population: INN-SWI-001) | participants | NUMBER |
| SECONDARY | ASEPSIS Score | 90 days post cardiac surgery | ITT population | score on a scale | MEAN |
| SECONDARY | Rehospitalization for Sternal Wound Infection | 90 days post cardiac surgery | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Surgical Wound Infections From Surgery Through Post-operative Day 90 | Gentamicin Group | 63 | Participants | ||
| Number of Participants With Surgical Wound Infections From Surgery Through Post-operative Day 90 | Control Group | 65 | Participants | ||
| Surgically Treated Surgical Wound Infection Postoperative Day 90 | Gentamicin Group | 25 | Participants | ||
| Surgically Treated Surgical Wound Infection Postoperative Day 90 | Control Group | 37 | Participants | ||
| Proportion of Patients With Deep Surgical Wound Infections Based on Centers for Disease Control Criteria Adjudicated by an Independent Blinded Committee. | Gentamicin Group | 14 | Participants | ||
| Proportion of Patients With Deep Surgical Wound Infections Based on Centers for Disease Control Criteria Adjudicated by an Independent Blinded Committee. | Control Group | 19 | Participants | ||
| Proportion of Patients With Superficial Surgical Wound Infections Based on Centers for Disease Control Criteria Adjudicated by an Independent Blinded Committee. | Gentamicin Group | 49 | Participants | ||
| Proportion of Patients With Superficial Surgical Wound Infections Based on Centers for Disease Control Criteria Adjudicated by an Independent Blinded Committee. | Control Group | 46 | Participants | ||
| Number of Participants Positive for Each Pathogen Culture | Gentamicin Group | Acinetobacter calcoaceticus | 1 | participants | |
| Number of Participants Positive for Each Pathogen Culture | Control Group | Acinetobacter calcoaceticus | 0 | participants |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gentamicin Group | 753 | |
| Overall Study | STARTED | Control Group | 749 | |
| Overall Study | COMPLETED | Gentamicin Group | 717 | |
| Overall Study | COMPLETED | Control Group | 702 | |
| Overall Study | NOT COMPLETED | Gentamicin Group | 36 | |
| Overall Study | NOT COMPLETED | Control Group | 47 |
Source ClinicalTrials.gov
Adverse events2,152
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Gentamicin Group | 320 | 743 | |
| other | Anaemia | Blood and lymphatic system disorders | Control Group | 326 | 759 | |
| other | Blood disorder | Blood and lymphatic system disorders | Gentamicin Group | 0 | 743 | |
| other | Blood disorder | Blood and lymphatic system disorders | Control Group | 1 | 759 | |
| other | Coagulopathy | Blood and lymphatic system disorders | Gentamicin Group | 4 | 743 | |
| other | Coagulopathy | Blood and lymphatic system disorders | Control Group | 1 | 759 | |
| other | Haemoconcentration | Blood and lymphatic system disorders | Gentamicin Group | 1 | 743 | |
| other | Haemoconcentration | Blood and lymphatic system disorders | Control Group | 0 | 759 | |
| other | Haemorrhagic anaemia | Blood and lymphatic system disorders | Gentamicin Group | 40 | 743 | |
| other | Haemorrhagic anaemia | Blood and lymphatic system disorders | Control Group | 51 | 759 |
1 to 10 of 2,152Source ClinicalTrials.gov
See all 2,152 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gentamicin Group | 19 | 743 |
| Total, all-cause mortality | Control Group | 27 | 759 |
| Total, other adverse events | Gentamicin Group | 741 | 743 |
| Total, other adverse events | Control Group | 757 | 759 |
| Total, serious adverse events | Gentamicin Group | 269 | 743 |
| Total, serious adverse events | Control Group | 290 | 759 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20716738 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Gentamicin Group vs Control Group: Proportion of Patients With Superficial Surgical Wound Infections Based on Centers for Disease Control Criteria Adjudicated by an Independent Blinded Committee. | Trial comparisons |
| Gentamicin Group vs Control Group: Proportion of Patients With Deep Surgical Wound Infections Based on Centers for Disease Control Criteria Adjudicated by an Independent Blinded Committee. | Trial comparisons |
| Gentamicin Group vs Control Group: Rehospitalization for Sternal Wound Infection | Trial comparisons |
| Gentamicin Group vs Control Group: Surgically Treated Surgical Wound Infection Postoperative Day 90 | Trial comparisons |
| Gentamicin Group vs Control Group: Number of Participants With Surgical Wound Infections From Surgery Through Post-operative Day 90 | Trial comparisons |
| Gentamicin Group vs Control Group: deaths from any cause | Trial comparisons |
| Gentamicin Group vs Control Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00600483
GET https://conductscience.org/api/trials/v1/NCT00600483/results?page=2