Trial Outcomes & Findings for Treatment Study of Vacuum Assisted Closure for Postsurgical Subcutaneous Abdominal Wound Healing Impairments (NCT NCT01528033)

Last Updated: 2020-06-25

Results Overview

Time (number of days) to achieve complete wound closure verified by photo documentation and blinded, computer-based wound quality assessment as well as wound closure confirmation after 14 consecutive days (14 days -0 / + 3) Complete wound closure is defined as: 100% epithelialization No drainage from the wound No need for adjuvant therapy or dressing No presence of sutures

Recruitment status

COMPLETED

Study phase

Target enrollment

539 participants

Primary outcome timeframe

42 days

Results posted on

2020-06-25

Participant Flow

Patients were enrolled betweenAugust 2, 2011, and January 31, 2018 in 34 abdominal surgical departments of hospitals in Germany, Belgium, and the Netherlands

Participant milestones

Participant milestones
Measure	Vacuum Assisted Closure® Negative pressure wound therapy Vacuum Assisted Closure®: Vacuum Assisted Closure® (V.A.C.®) Therapy within a maximum study treatment time of 42 days. VAC® Therapy Systems used within the trial are ActiV.A.C.®, InfoV.A.C.®, V.A.C. Freedom®, V.A.C. Via® and VAC Ulta®. All used systems are equally eligible for the treatment of subcutaneous abdominal wounds and should be used according to availability and local preferences within the study site. Systems differ regarding user surface and display and processing of data. For the treatment of subcutaneous abdominal wounds the V.A.C.® Granufoam Dressing (size medium and big) is recommended.	Standard Conventional Wound Therapy According to institutional clinical standards Standard conventional wound therapy: Standard conventional wound therapy (SCWT) according to institutional clinical standards within a maximum study treatment time of 42 days
Primary Endpoint Assessment ITT STARTED	273	266
Primary Endpoint Assessment ITT COMPLETED	256	251
Primary Endpoint Assessment ITT NOT COMPLETED	17	15
Follow Up STARTED	256	251
Follow Up COMPLETED	210	207
Follow Up NOT COMPLETED	46	44

Reasons for withdrawal

Reasons for withdrawal
Measure	Vacuum Assisted Closure® Negative pressure wound therapy Vacuum Assisted Closure®: Vacuum Assisted Closure® (V.A.C.®) Therapy within a maximum study treatment time of 42 days. VAC® Therapy Systems used within the trial are ActiV.A.C.®, InfoV.A.C.®, V.A.C. Freedom®, V.A.C. Via® and VAC Ulta®. All used systems are equally eligible for the treatment of subcutaneous abdominal wounds and should be used according to availability and local preferences within the study site. Systems differ regarding user surface and display and processing of data. For the treatment of subcutaneous abdominal wounds the V.A.C.® Granufoam Dressing (size medium and big) is recommended.	Standard Conventional Wound Therapy According to institutional clinical standards Standard conventional wound therapy: Standard conventional wound therapy (SCWT) according to institutional clinical standards within a maximum study treatment time of 42 days
Primary Endpoint Assessment ITT Withdrawal by Subject	8	7
Primary Endpoint Assessment ITT No or deliquent informed consent	3	3
Primary Endpoint Assessment ITT Death	2	2
Primary Endpoint Assessment ITT Physician Decision	2	1
Primary Endpoint Assessment ITT No post baseline documentation	2	2
Follow Up No data available	46	44

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 42 days

Population: Intention To Treat Population

Outcome measures

Outcome measures
Measure	NPWT n=256 Participants Negative Pressure Wound Therapy	SCWT n=251 Participants Standard Conventional Wound Treatment
Time to Complete Wound Closure	36.1 Days Interval 35.0 to 37.2	39.1 Days Interval 38.3 to 40.0

SECONDARY outcome

Timeframe: 42 days

Population: Intention To Treat Population

Incidence of confirmed and verified wound closure achieved after a maximum study observation / treatment period of 42 days (+ 14 days to observe sustained closure)

Outcome measures

Outcome measures
Measure	NPWT n=256 Participants Negative Pressure Wound Therapy	SCWT n=251 Participants Standard Conventional Wound Treatment
Incidence of Confirmed and Verified Wound Closure	92 Participants	54 Participants

SECONDARY outcome

Timeframe: 132 days

Population: Intention To Treat Population

Recurrence of wound opening after confirmed wound closure

Outcome measures

Outcome measures
Measure	NPWT n=256 Participants Negative Pressure Wound Therapy	SCWT n=251 Participants Standard Conventional Wound Treatment
Recurrence	0 Participants	0 Participants

Adverse Events

NPWT

Serious events: 22 serious events

Other events: 41 other events

Deaths: 24 deaths

SCWT

Serious events: 12 serious events

Other events: 22 other events

Deaths: 15 deaths

Serious adverse events

Serious adverse events
Measure	NPWT n=234 participants at risk Negative Pressure Wound Therapy	SCWT n=201 participants at risk Standard Conventional Wound Treatment
Surgical and medical procedures Adverse Device Events (NPWT-related)	0.00% 0/234 • 42 days for Adverse Events (AEs) and unsustained wound closures 132 days for Serious Adverse Events (SAEs) Mortality is presented for the ITT Population (NPWT N=256; SCWT N=251). AEs and SAEs were only collected if treatment-related. NPWT-, SCWT- and wound-related AEs were analyzed based on the Therapy Compliant (TC) population (study participants without unauthorized treatment changes) (N total NPWT=234; N total SCWT=201).This enables a clear assignment of the adverse event to one of the two treatment methods for study participants who actually received the randomized therapy.	0.00% 0/201 • 42 days for Adverse Events (AEs) and unsustained wound closures 132 days for Serious Adverse Events (SAEs) Mortality is presented for the ITT Population (NPWT N=256; SCWT N=251). AEs and SAEs were only collected if treatment-related. NPWT-, SCWT- and wound-related AEs were analyzed based on the Therapy Compliant (TC) population (study participants without unauthorized treatment changes) (N total NPWT=234; N total SCWT=201).This enables a clear assignment of the adverse event to one of the two treatment methods for study participants who actually received the randomized therapy.
Skin and subcutaneous tissue disorders Conventional Wound Treatment-related	0.00% 0/234 • 42 days for Adverse Events (AEs) and unsustained wound closures 132 days for Serious Adverse Events (SAEs) Mortality is presented for the ITT Population (NPWT N=256; SCWT N=251). AEs and SAEs were only collected if treatment-related. NPWT-, SCWT- and wound-related AEs were analyzed based on the Therapy Compliant (TC) population (study participants without unauthorized treatment changes) (N total NPWT=234; N total SCWT=201).This enables a clear assignment of the adverse event to one of the two treatment methods for study participants who actually received the randomized therapy.	0.00% 0/201 • 42 days for Adverse Events (AEs) and unsustained wound closures 132 days for Serious Adverse Events (SAEs) Mortality is presented for the ITT Population (NPWT N=256; SCWT N=251). AEs and SAEs were only collected if treatment-related. NPWT-, SCWT- and wound-related AEs were analyzed based on the Therapy Compliant (TC) population (study participants without unauthorized treatment changes) (N total NPWT=234; N total SCWT=201).This enables a clear assignment of the adverse event to one of the two treatment methods for study participants who actually received the randomized therapy.
Skin and subcutaneous tissue disorders Wound-related	9.4% 22/234 • Number of events 29 • 42 days for Adverse Events (AEs) and unsustained wound closures 132 days for Serious Adverse Events (SAEs) Mortality is presented for the ITT Population (NPWT N=256; SCWT N=251). AEs and SAEs were only collected if treatment-related. NPWT-, SCWT- and wound-related AEs were analyzed based on the Therapy Compliant (TC) population (study participants without unauthorized treatment changes) (N total NPWT=234; N total SCWT=201).This enables a clear assignment of the adverse event to one of the two treatment methods for study participants who actually received the randomized therapy.	6.0% 12/201 • Number of events 12 • 42 days for Adverse Events (AEs) and unsustained wound closures 132 days for Serious Adverse Events (SAEs) Mortality is presented for the ITT Population (NPWT N=256; SCWT N=251). AEs and SAEs were only collected if treatment-related. NPWT-, SCWT- and wound-related AEs were analyzed based on the Therapy Compliant (TC) population (study participants without unauthorized treatment changes) (N total NPWT=234; N total SCWT=201).This enables a clear assignment of the adverse event to one of the two treatment methods for study participants who actually received the randomized therapy.

Other adverse events

Other adverse events
Measure	NPWT n=234 participants at risk Negative Pressure Wound Therapy	SCWT n=201 participants at risk Standard Conventional Wound Treatment
Surgical and medical procedures Adverse Device Events (NPWT-related)	5.6% 13/234 • Number of events 23 • 42 days for Adverse Events (AEs) and unsustained wound closures 132 days for Serious Adverse Events (SAEs) Mortality is presented for the ITT Population (NPWT N=256; SCWT N=251). AEs and SAEs were only collected if treatment-related. NPWT-, SCWT- and wound-related AEs were analyzed based on the Therapy Compliant (TC) population (study participants without unauthorized treatment changes) (N total NPWT=234; N total SCWT=201).This enables a clear assignment of the adverse event to one of the two treatment methods for study participants who actually received the randomized therapy.	0.00% 0/201 • 42 days for Adverse Events (AEs) and unsustained wound closures 132 days for Serious Adverse Events (SAEs) Mortality is presented for the ITT Population (NPWT N=256; SCWT N=251). AEs and SAEs were only collected if treatment-related. NPWT-, SCWT- and wound-related AEs were analyzed based on the Therapy Compliant (TC) population (study participants without unauthorized treatment changes) (N total NPWT=234; N total SCWT=201).This enables a clear assignment of the adverse event to one of the two treatment methods for study participants who actually received the randomized therapy.
Skin and subcutaneous tissue disorders Conventional Wound Treatment - related	0.43% 1/234 • Number of events 1 • 42 days for Adverse Events (AEs) and unsustained wound closures 132 days for Serious Adverse Events (SAEs) Mortality is presented for the ITT Population (NPWT N=256; SCWT N=251). AEs and SAEs were only collected if treatment-related. NPWT-, SCWT- and wound-related AEs were analyzed based on the Therapy Compliant (TC) population (study participants without unauthorized treatment changes) (N total NPWT=234; N total SCWT=201).This enables a clear assignment of the adverse event to one of the two treatment methods for study participants who actually received the randomized therapy.	0.50% 1/201 • Number of events 1 • 42 days for Adverse Events (AEs) and unsustained wound closures 132 days for Serious Adverse Events (SAEs) Mortality is presented for the ITT Population (NPWT N=256; SCWT N=251). AEs and SAEs were only collected if treatment-related. NPWT-, SCWT- and wound-related AEs were analyzed based on the Therapy Compliant (TC) population (study participants without unauthorized treatment changes) (N total NPWT=234; N total SCWT=201).This enables a clear assignment of the adverse event to one of the two treatment methods for study participants who actually received the randomized therapy.
Skin and subcutaneous tissue disorders Wound-related	17.5% 41/234 • Number of events 51 • 42 days for Adverse Events (AEs) and unsustained wound closures 132 days for Serious Adverse Events (SAEs) Mortality is presented for the ITT Population (NPWT N=256; SCWT N=251). AEs and SAEs were only collected if treatment-related. NPWT-, SCWT- and wound-related AEs were analyzed based on the Therapy Compliant (TC) population (study participants without unauthorized treatment changes) (N total NPWT=234; N total SCWT=201).This enables a clear assignment of the adverse event to one of the two treatment methods for study participants who actually received the randomized therapy.	10.9% 22/201 • Number of events 29 • 42 days for Adverse Events (AEs) and unsustained wound closures 132 days for Serious Adverse Events (SAEs) Mortality is presented for the ITT Population (NPWT N=256; SCWT N=251). AEs and SAEs were only collected if treatment-related. NPWT-, SCWT- and wound-related AEs were analyzed based on the Therapy Compliant (TC) population (study participants without unauthorized treatment changes) (N total NPWT=234; N total SCWT=201).This enables a clear assignment of the adverse event to one of the two treatment methods for study participants who actually received the randomized therapy.

Additional Information

Dörthe Seidel

Witten/Herdecke University

Phone: 00492219895731

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	NPWT n=256 Participants Negative Pressure Wound Therapy	SCWT n=251 Participants Standard Conventional Wound Treatment	Total n=507 Participants Total of all reporting groups
Age, Continuous	64 years STANDARD_DEVIATION 13 • n=256 Participants	64 years STANDARD_DEVIATION 14 • n=251 Participants	64 years STANDARD_DEVIATION 13 • n=507 Participants
Sex: Female, Male Female	101 Participants n=256 Participants	119 Participants n=251 Participants	220 Participants n=507 Participants
Sex: Female, Male Male	155 Participants n=256 Participants	132 Participants n=251 Participants	287 Participants n=507 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Germany	245 participants n=256 Participants	241 participants n=251 Participants	486 participants n=507 Participants
Region of Enrollment Netherlands	2 participants n=256 Participants	1 participants n=251 Participants	3 participants n=507 Participants
Region of Enrollment Belgium	7 participants n=256 Participants	9 participants n=251 Participants	16 participants n=507 Participants
Weight	86 Kilogram STANDARD_DEVIATION 19 • n=256 Participants	84 Kilogram STANDARD_DEVIATION 21 • n=251 Participants	85 Kilogram STANDARD_DEVIATION 20 • n=507 Participants
Height	172 Centimeters STANDARD_DEVIATION 11 • n=256 Participants	169 Centimeters STANDARD_DEVIATION 11 • n=251 Participants	171 Centimeters STANDARD_DEVIATION 11 • n=507 Participants
BMI	28.71 kg/m² STANDARD_DEVIATION 8.58 • n=256 Participants	29.5 kg/m² STANDARD_DEVIATION 10.2 • n=251 Participants	29.4 kg/m² STANDARD_DEVIATION 8.4 • n=507 Participants
Smoking	65 Participants n=256 Participants	55 Participants n=251 Participants	120 Participants n=507 Participants
Alcohol use	111 Participants n=255 Participants • Only for those patientes with information available	114 Participants n=250 Participants • Only for those patientes with information available	225 Participants n=505 Participants • Only for those patientes with information available
Drug use	3 Participants n=256 Participants	3 Participants n=251 Participants	6 Participants n=507 Participants
Nutritional status Well nourished	235 Participants n=256 Participants	222 Participants n=251 Participants	457 Participants n=507 Participants
Nutritional status Moderately or suspected of being malnourished	18 Participants n=256 Participants	26 Participants n=251 Participants	44 Participants n=507 Participants
Nutritional status Severely malnourished	3 Participants n=256 Participants	3 Participants n=251 Participants	6 Participants n=507 Participants
Wound volume <=60 cm*3	149 Participants n=256 Participants • Only for those patients with available Information	142 Participants n=249 Participants • Only for those patients with available Information	291 Participants n=505 Participants • Only for those patients with available Information
Wound volume >60 cm*3	107 Participants n=256 Participants • Only for those patients with available Information	107 Participants n=249 Participants • Only for those patients with available Information	214 Participants n=505 Participants • Only for those patients with available Information
Coagulation: Prothrombin Time (PT)	88.3 percentage (%) STANDARD_DEVIATION 16.2 • n=149 Participants • Laboratory values are only available for patients with blood samples collected within clinical routine	88.3 percentage (%) STANDARD_DEVIATION 17.8 • n=148 Participants • Laboratory values are only available for patients with blood samples collected within clinical routine	88.3 percentage (%) STANDARD_DEVIATION 17.0 • n=297 Participants • Laboratory values are only available for patients with blood samples collected within clinical routine
Coagulation: International Normalized Ratio (INR)	1.1 ratio STANDARD_DEVIATION 0.2 • n=145 Participants • Laboratory values are only available for patients with blood samples collected within clinical routine	1.1 ratio STANDARD_DEVIATION 0.2 • n=145 Participants • Laboratory values are only available for patients with blood samples collected within clinical routine	1.1 ratio STANDARD_DEVIATION 0.2 • n=290 Participants • Laboratory values are only available for patients with blood samples collected within clinical routine
Coagulation: Partial Thromboplastin Time (pTT)	33.9 seconds (s) STANDARD_DEVIATION 10.8 • n=146 Participants • Laboratory values are only available for patients with blood samples collected within clinical routine	32.5 seconds (s) STANDARD_DEVIATION 10.4 • n=146 Participants • Laboratory values are only available for patients with blood samples collected within clinical routine	33.2 seconds (s) STANDARD_DEVIATION 10.6 • n=292 Participants • Laboratory values are only available for patients with blood samples collected within clinical routine
Diagnosis of abdominal wound healing disorder Spontaneous dehiscence	57 Participants n=256 Participants	52 Participants n=251 Participants	109 Participants n=507 Participants
Diagnosis of abdominal wound healing disorder Active reopening	198 Participants n=256 Participants	193 Participants n=251 Participants	391 Participants n=507 Participants
Diagnosis of abdominal wound healing disorder Wound left open after surgery	2 Participants n=256 Participants	9 Participants n=251 Participants	11 Participants n=507 Participants
Clinical signs of infection during screening No	122 Participants n=256 Participants • Only for those patients with Information available	116 Participants n=250 Participants • Only for those patients with Information available	238 Participants n=506 Participants • Only for those patients with Information available
Clinical signs of infection during screening Not assesable	29 Participants n=256 Participants • Only for those patients with Information available	24 Participants n=250 Participants • Only for those patients with Information available	53 Participants n=506 Participants • Only for those patients with Information available
Clinical signs of infection during screening Yes	105 Participants n=256 Participants • Only for those patients with Information available	110 Participants n=250 Participants • Only for those patients with Information available	215 Participants n=506 Participants • Only for those patients with Information available
Leven of surgical site infection according to CDC classification at Screening Superficial incisional	65 Participants n=104 Participants • Only for those patients with signs of clinical infection during Screening (NPWT=105; SCWT=110) and documentation availabe (NPWT=104; SCWT=110)	67 Participants n=110 Participants • Only for those patients with signs of clinical infection during Screening (NPWT=105; SCWT=110) and documentation availabe (NPWT=104; SCWT=110)	132 Participants n=214 Participants • Only for those patients with signs of clinical infection during Screening (NPWT=105; SCWT=110) and documentation availabe (NPWT=104; SCWT=110)
Leven of surgical site infection according to CDC classification at Screening Deep incisional	37 Participants n=104 Participants • Only for those patients with signs of clinical infection during Screening (NPWT=105; SCWT=110) and documentation availabe (NPWT=104; SCWT=110)	39 Participants n=110 Participants • Only for those patients with signs of clinical infection during Screening (NPWT=105; SCWT=110) and documentation availabe (NPWT=104; SCWT=110)	76 Participants n=214 Participants • Only for those patients with signs of clinical infection during Screening (NPWT=105; SCWT=110) and documentation availabe (NPWT=104; SCWT=110)
Leven of surgical site infection according to CDC classification at Screening Organ or space infection	2 Participants n=104 Participants • Only for those patients with signs of clinical infection during Screening (NPWT=105; SCWT=110) and documentation availabe (NPWT=104; SCWT=110)	4 Participants n=110 Participants • Only for those patients with signs of clinical infection during Screening (NPWT=105; SCWT=110) and documentation availabe (NPWT=104; SCWT=110)	6 Participants n=214 Participants • Only for those patients with signs of clinical infection during Screening (NPWT=105; SCWT=110) and documentation availabe (NPWT=104; SCWT=110)
Clinical signs of local infection at randomization, No	133 Participants n=247 Participants • Patients with documentation availabe at Randomization = 247	130 Participants n=245 Participants • Patients with documentation availabe at Randomization = 247	263 Participants n=492 Participants • Patients with documentation availabe at Randomization = 247
Clinical signs of local infection at randomization, Not assessable	39 Participants n=247 Participants • Patients with documentation availabe at Randomization = 247	36 Participants n=245 Participants • Patients with documentation availabe at Randomization = 247	75 Participants n=492 Participants • Patients with documentation availabe at Randomization = 247
Clinical signs of local infection at randomization, Yes	75 Participants n=247 Participants • Patients with documentation availabe at Randomization = 247	79 Participants n=245 Participants • Patients with documentation availabe at Randomization = 247	154 Participants n=492 Participants • Patients with documentation availabe at Randomization = 247
Level of surgical site infection according to CDC classification at Randomization Superficial incisional	43 Participants n=73 Participants • Only availabe for those patients with clinical signs of local infection during randomization (NPWT=75; SCWT=79) and documentation available (NPWT=73; SCWT=79)	43 Participants n=79 Participants • Only availabe for those patients with clinical signs of local infection during randomization (NPWT=75; SCWT=79) and documentation available (NPWT=73; SCWT=79)	86 Participants n=152 Participants • Only availabe for those patients with clinical signs of local infection during randomization (NPWT=75; SCWT=79) and documentation available (NPWT=73; SCWT=79)
Level of surgical site infection according to CDC classification at Randomization Deep incisional	28 Participants n=73 Participants • Only availabe for those patients with clinical signs of local infection during randomization (NPWT=75; SCWT=79) and documentation available (NPWT=73; SCWT=79)	34 Participants n=79 Participants • Only availabe for those patients with clinical signs of local infection during randomization (NPWT=75; SCWT=79) and documentation available (NPWT=73; SCWT=79)	62 Participants n=152 Participants • Only availabe for those patients with clinical signs of local infection during randomization (NPWT=75; SCWT=79) and documentation available (NPWT=73; SCWT=79)
Level of surgical site infection according to CDC classification at Randomization Organ or space infection	2 Participants n=73 Participants • Only availabe for those patients with clinical signs of local infection during randomization (NPWT=75; SCWT=79) and documentation available (NPWT=73; SCWT=79)	2 Participants n=79 Participants • Only availabe for those patients with clinical signs of local infection during randomization (NPWT=75; SCWT=79) and documentation available (NPWT=73; SCWT=79)	4 Participants n=152 Participants • Only availabe for those patients with clinical signs of local infection during randomization (NPWT=75; SCWT=79) and documentation available (NPWT=73; SCWT=79)
Main procedure that caused the abdominal wound healing impairment Incision, excision, resection and anastomose of th	94 Participants n=255 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)	93 Participants n=248 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)	187 Participants n=503 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)
Main procedure that caused the abdominal wound healing impairment Other operations on the small and large intestine	35 Participants n=255 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)	30 Participants n=248 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)	65 Participants n=503 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)
Main procedure that caused the abdominal wound healing impairment Appendix surgery	14 Participants n=255 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)	13 Participants n=248 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)	27 Participants n=503 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)
Main procedure that caused the abdominal wound healing impairment Rectal surgery	22 Participants n=255 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)	20 Participants n=248 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)	42 Participants n=503 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)
Main procedure that caused the abdominal wound healing impairment Anal surgery	0 Participants n=255 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)	0 Participants n=248 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)	0 Participants n=503 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)
Main procedure that caused the abdominal wound healing impairment Esophagus surgery	0 Participants n=255 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)	2 Participants n=248 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)	2 Participants n=503 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)
Main procedure that caused the abdominal wound healing impairment Gastric incision, excision, and resection	6 Participants n=255 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)	4 Participants n=248 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)	10 Participants n=503 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)
Main procedure that caused the abdominal wound healing impairment Extended gastric resection and other gastric surge	3 Participants n=255 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)	0 Participants n=248 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)	3 Participants n=503 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)
Main procedure that caused the abdominal wound healing impairment Liver surgery	8 Participants n=255 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)	8 Participants n=248 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)	16 Participants n=503 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)
Main procedure that caused the abdominal wound healing impairment Gall bladder and bile ducts surgery	23 Participants n=255 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)	17 Participants n=248 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)	40 Participants n=503 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)
Main procedure that caused the abdominal wound healing impairment Pancreatic surgery	13 Participants n=255 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)	11 Participants n=248 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)	24 Participants n=503 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)
Main procedure that caused the abdominal wound healing impairment Closure of abdominal hernias	18 Participants n=255 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)	13 Participants n=248 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)	31 Participants n=503 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)
Main procedure that caused the abdominal wound healing impairment Operations on other abdominal regions	15 Participants n=255 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)	27 Participants n=248 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)	42 Participants n=503 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)
Main procedure that caused the abdominal wound healing impairment Other	4 Participants n=255 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)	10 Participants n=248 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)	14 Participants n=503 Participants • Only for those patients with documentation available (NPWT=255; SCWT=248)