Trial Outcomes & Findings for A Clinical Trial Using Spy Elite System in Planning Tissue Advancement Flaps After Ventral Hernia Repair (NCT NCT01886963)
NCT ID: NCT01886963
Last Updated: 2022-04-21
Results Overview
breakdown, necrosis, erythema, infection, or dehiscence with location specified
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
115 participants
Primary outcome timeframe
12 Weeks
Results posted on
2022-04-21
Participant Flow
Participant milestones
| Measure |
SPY - Unblinded Use of SPY Elite
SPY - Unblinded use of SPY Elite will have incision and advancement flap performed based on assessment of blood supply using the Spy Elite system, as well as potential flap revision if portions of the flap appear under-perfused in the pre-closure imaging. Patients will be blinded to if intraoperative Spy Elite imaging was used. Digital photographs of the surgical wound taken by surgical team daily until discharge, and on follow-up visits post-operatively. Digital photographs will be reviewed by a blinded surgeon, who will assess the wound for complications (breakdown, necrosis, erythema, infection, or dehiscence with location specified) and assessment of healing. Upon study completion, groups will be compared for wound complications, presence of flap necrosis, quantification of flap necrosis, and healing speed.
SPY - Unblinded Use of Spy Elite: Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging
|
Control - Blinded Use of SPY Elite
Control - Blinded use of SPY Elite will consist of intraoperative abdominal wall imaging prior to incision, followed by ventral hernia repair with subcutaneous advancement flaps without viewing the imaging contained within the Spy Elite system. A digital photograph will be taken before and immediately after initial incision, as well as immediately prior to and after closure. The patient will have digital photographs of the surgical wound taken by the surgical team daily until discharge, and on follow-up visits at one week, two weeks, four weeks and twelve weeks. After twenty patients have completed phase I, the surgical team will be unblinded to Spy Elite imaging. The Spy Elite imaging and all digital photographs of all patients will be reviewed.
Control - Blinded Use of Spy Elite: Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
58
|
|
Overall Study
2 Week Follow Up
|
55
|
55
|
|
Overall Study
4 Week Follow Up
|
50
|
51
|
|
Overall Study
12 Week Follow Up
|
46
|
49
|
|
Overall Study
COMPLETED
|
46
|
49
|
|
Overall Study
NOT COMPLETED
|
11
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Trial Using Spy Elite System in Planning Tissue Advancement Flaps After Ventral Hernia Repair
Baseline characteristics by cohort
| Measure |
Control - Blinded Use of SPY Elite
n=49 Participants
Group A will consist of intraoperative abdominal wall imaging prior to incision, followed by ventral hernia repair with subcutaneous advancement flaps without viewing the imaging contained within the Spy Elite system. A digital photograph will be taken before and immediately after initial incision, as well as immediately prior to and after closure. The patient will have digital photographs of the surgical wound taken by the surgical team daily until discharge, and on follow-up visits at one week, two weeks, four weeks and twelve weeks. After twenty patients have completed phase I, the surgical team will be unblinded to Spy Elite imaging. The Spy Elite imaging and all digital photographs of all patients will be reviewed.
Ventral Hernia Repair with Advancement Flaps with Blinded Use of Spy Elite (Control): Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone
|
SPY - Unblinded Use of SPY Elite
n=46 Participants
Group B will have incision and advancement flap performed based on assessment of blood supply using the Spy Elite system, as well as potential flap revision if portions of the flap appear under-perfused in the pre-closure imaging. Patients will be blinded to if intraoperative Spy Elite imaging was used. Digital photographs of the surgical wound taken by surgical team daily until discharge, and on follow-up visits post-operatively. Digital photographs will be reviewed by a blinded surgeon, who will assess the wound for complications (breakdown, necrosis, erythema, infection, or dehiscence with location specified) and assessment of healing. Upon study completion, groups will be compared for wound complications, presence of flap necrosis, quantification of flap necrosis, and healing speed.
VHR with Advancement Flaps with Unblinded Use of Spy Elite (Experimental): Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 11.76 • n=5 Participants
|
56.7 years
STANDARD_DEVIATION 11.16 • n=7 Participants
|
57.6 years
STANDARD_DEVIATION 11.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
46 participants
n=7 Participants
|
95 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 Weeksbreakdown, necrosis, erythema, infection, or dehiscence with location specified
Outcome measures
| Measure |
Group A
n=49 Participants
Group A will consist of intraoperative abdominal wall imaging prior to incision, followed by ventral hernia repair with subcutaneous advancement flaps without viewing the imaging contained within the Spy Elite system. A digital photograph will be taken before and immediately after initial incision, as well as immediately prior to and after closure. The patient will have digital photographs of the surgical wound taken by the surgical team daily until discharge, and on follow-up visits at one week, two weeks, four weeks and twelve weeks. After twenty patients have completed phase I, the surgical team will be unblinded to Spy Elite imaging. The Spy Elite imaging and all digital photographs of all patients will be reviewed.
Ventral Hernia Repair with Advancement Flaps with Blinded Use of Spy Elite (Control): Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone
|
Group B
n=46 Participants
Group B will have incision and advancement flap performed based on assessment of blood supply using the Spy Elite system, as well as potential flap revision if portions of the flap appear under-perfused in the pre-closure imaging. Patients will be blinded to if intraoperative Spy Elite imaging was used. Digital photographs of the surgical wound taken by surgical team daily until discharge, and on follow-up visits post-operatively. Digital photographs will be reviewed by a blinded surgeon, who will assess the wound for complications (breakdown, necrosis, erythema, infection, or dehiscence with location specified) and assessment of healing. Upon study completion, groups will be compared for wound complications, presence of flap necrosis, quantification of flap necrosis, and healing speed.
VHR with Advancement Flaps with Unblinded Use of Spy Elite (Experimental): Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging
|
|---|---|---|
|
Number of Participants With Wound Complications
|
16 participants
|
17 participants
|
Adverse Events
SPY - Unblinded Use of SPY Elite
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Control - Blinded Use of SPY Elite
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SPY - Unblinded Use of SPY Elite
n=46 participants at risk
SPY - Unblinded use of SPY Elite will have incision and advancement flap performed based on assessment of blood supply using the Spy Elite system, as well as potential flap revision if portions of the flap appear under-perfused in the pre-closure imaging. Patients will be blinded to if intraoperative Spy Elite imaging was used. Digital photographs of the surgical wound taken by surgical team daily until discharge, and on follow-up visits post-operatively. Digital photographs will be reviewed by a blinded surgeon, who will assess the wound for complications (breakdown, necrosis, erythema, infection, or dehiscence with location specified) and assessment of healing. Upon study completion, groups will be compared for wound complications, presence of flap necrosis, quantification of flap necrosis, and healing speed.
SPY - Unblinded use of Spy Elite: Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging
|
Control - Blinded Use of SPY Elite
n=49 participants at risk
Control - Blinded use of SPY Elite will consist of intraoperative abdominal wall imaging prior to incision, followed by ventra l hernia repair with subcutaneous advancement flaps without viewing the imaging contained within the Spy Elite system. A digital photograph will be taken before and immediately after initial incision, as well as immediately prior to and after closure. The patient will have digital photographs of the surgical wound taken by the surgical team daily until discharge, and on follow-up visits at one week, two weeks, four weeks and twelve weeks. After twenty patients have completed phase I, the surgical team will be unblinded to Spy Elite imaging. The Spy Elite imaging and all digital photographs of all patients will be reviewed.
Control - Blinded Use of Spy Elite: Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Embolism
|
6.5%
3/46 • All patients had a minimum of 30 days follow up to collect for adverse events; however the mean follow up was 8.3 months for patients included in the trial analysis.
|
4.1%
2/49 • All patients had a minimum of 30 days follow up to collect for adverse events; however the mean follow up was 8.3 months for patients included in the trial analysis.
|
|
General disorders
Deceased
|
2.2%
1/46 • All patients had a minimum of 30 days follow up to collect for adverse events; however the mean follow up was 8.3 months for patients included in the trial analysis.
|
0.00%
0/49 • All patients had a minimum of 30 days follow up to collect for adverse events; however the mean follow up was 8.3 months for patients included in the trial analysis.
|
|
Surgical and medical procedures
Vital Signs
|
2.2%
1/46 • All patients had a minimum of 30 days follow up to collect for adverse events; however the mean follow up was 8.3 months for patients included in the trial analysis.
|
0.00%
0/49 • All patients had a minimum of 30 days follow up to collect for adverse events; however the mean follow up was 8.3 months for patients included in the trial analysis.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60