Condition category
Surgery
Date applied
18/05/2020
Date assigned
31/05/2020
Last edited
02/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Postoperative abdominal wound dehiscence (PAWD) is also known as a burst abdomen. It can occur on average during the 7th day after surgery (postoperative) but may range between 1-23 days. An open abdomen or laparotomy wound is a general term for when the abdomen which is left intentionally open without any primary closure in critically ill patients where definitive repair is performed after a few weeks. Although there are a good number of studies on the effect of vacuum-assisted closure (VAC) therapy for open abdomen, very few studies have reported its usefulness in postoperative abdominal wound dehiscence. Therefore the aim of this study is to find out whether VAC therapy promotes healing in postoperative abdominal wound dehiscence.

Who can participate?
All patients aged over 18 who develop abdominal wound dehiscence in the postoperative period, excluding critically ill and ICU, bile leak patients

What does the study involve?
All patients are treated with VAC therapy and wound healing is assessed.

What are the possible benefits and risks of participating?
Possible benefits include improvement from local sepsis, early ambulation (walking), and early discharge from hospital. Possible risks include bleeding and pain.

Where is the study run from?
All India Institute of Medical Sciences Bhubaneswar (India)

When is the study starting and how long is it expected to run for?
May 2017 to December 2019

Who is funding the study?
All India Institute of Medical Sciences Bhubaneswar (India)

Who is the main contact?
Dr S. Manwar Ali
surg_manwar@aiimsbhubaneswar.edu.in

Trial website

Contact information

Type

Scientific

Primary contact

Dr Edla Vamshi Krishna

ORCID ID

Contact details

Department of General Surgery
All India Institute of Medical Sciences
Bhubaneswar
751019
India
+91 (0)7077980212/+91 (0)9959972447
vamshi25krishna@gmail.com

Type

Scientific

Additional contact

Dr S Manwar Ali

ORCID ID

Contact details

Department of General Surgery
All India Institute of Medical Sciences
Bhubaneswar
751019
India
+91 (0)9488820340
surg_manwar@aiimsbhubaneswar.edu.in

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

researchregistry5597

Study information

Scientific title

Assessing the effect of vacuum-assisted closure therapy in postoperative abdominal wound dehiscence: an observational study

Acronym

Study hypothesis

Vacuum-assisted closure therapy (VAC) is a well-known technique used for the treatment of diabetic wounds, infected orthopaedic wounds, sternotomy wounds. Systematic reviews reported good facial closure rates with VAC therapy in open abdomen. Whereas very few studies reported its usefulness in postoperative abdominal wound dehiscence and most of them are retrospective studies. Therefore the researchers designed a prospective study on VAC therapy to know its effectiveness in PAWD. The aim of this study is to measure the effect of VAC therapy in terms of decreasing local sepsis, promoting granulation tissue and thereby achieving early cutaneous cover in postoperative abdominal wound dehiscence.

Ethics approval

Approved 26/07/2017, Institutional Ethics Committee, All India Institute of Medical Sciences, Bhubaneswar (Institute research cell, AIIMS, Bhubaneswar, Odisha, 751019, India; +91 (0)9438884016; iec@aiimsbhubaneswar.edu.in), ref: IEC/AIIMS/BBSR/PG THESIS/2017-18/21

Study design

Single-centre observational longitudinal cross-sectional study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format. Please use contact details to request a participant information sheet.

Condition

Postoperative abdominal wound dehiscence

Intervention

The data, including wound type, size for each patient are collected in a standardized manner. Then under sterile conditions, adequate debridement and saline irrigation are done followed by paraffin-impregnated gauze pieces applied in at least two layers over the wound in such a way that the bowel is completely covered. It serves as a protective layer, and the purpose of this layer is to completely prevent contact between the bowel and the polyurethane (PU) foam. The foam is cut as per the wound size and placed over paraffin gauze in such a way that it has contact with all the edges. An adhesive drape is then applied over the foam. A 2-cm hole is made at the center of this drape to allow a suction drain to fit over it. The suction tube is then connected to a commercially available VAC device. The negative pressure was set at a range of 75-100 mmHg, either in a continuous or intermittent mode. The dressings were changed every 48-72 hours depending on the exudates collected in the canister. Therapy continued until granulation or apposition of tissue is achieved and aborted in case of excessive pain or bleeding.

Intervention type

Device

Phase

Not Applicable

Drug names

Primary outcome measure

1. Duration for achieving a cutaneous cover or granulation tissue without any local sepsis:
1.1. Cutaneous cover: the time (days) from the day of VAC application until the wound is covered with skin grafting or secondary suturing or by secondary intion of healing
2.2. Granulation tissue appearance and no local sepsis: the day when there is no or minimal pus discharge with healthy red granulation tissue appearance after the 1st VAC application. A macroscopic objective observed after each VAC application
2. Duration of hospital stay, measured using medical records as the time (days) between the 1st VAC application until discharge from the hospital

Secondary outcome measures

1. Total leukocyte counts measured with a routine complete blood picture before 1st VAC and after the 2nd VAC
2. Wound size measured with a standard scale before and after application of VAC
3. Amount of negative pressure applied: the average amount of negative pressure (mmHg) applied for each patient measured after the last VAC
4. Total sessions of VAC dressings required: each VAC dressing is noted in the record and the total sessions of dressings applied were noted at the time of discharge
5. Total cost of therapy: the cost applied for each VAC and total amount calculated after the end of last VAC
6. Incisional hernia measured clinically as well as by ultrasound during 6 months of follow up

Overall trial start date

20/05/2017

Overall trial end date

26/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients who underwent VAC. therapy for sheath dehiscence developed in the postoperative period between 2017 to 2019
2. Patients above 18 years of age including both males and females

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

46

Total final enrolment

46

Participant exclusion criteria

1. Patients who had only skin dehiscence
2. Postoperative ascites
3. Bile leak
4. Entero cutaneous fistulas
5. Metastatic carcinoma
6. Multi-organ dysfunction
7. Critically ill patients on a ventilator
8. Those who needed further exploration

Recruitment start date

10/08/2017

Recruitment end date

29/07/2019

Locations

Countries of recruitment

India

Trial participating centre

All India Institute of Medical Sciences, Bhubaneswar, Odisha, India
Department of General Surgery, AIIMS
Bhubaneswar
751019
India

Sponsor information

Organisation

All India Institute of Medical Sciences Bhubaneswar

Sponsor details

Sijua
Patrapada
Bhubaneswar
751019
India
+91 (0)674 2476789
info@aiimsbhubaneswar.edu.in

Sponsor type

Hospital/treatment centre

Website

http://aiimsbhubaneswar.nic.in/

Funders

Funder type

Hospital/treatment centre

Funder name

All India Institute of Medical Sciences Bhubaneswar

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The researchers are intending to publish the results as they feel that the results can be very much put in to use for postoperative wound care relating to burst abdomen.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr E Vamshi Krishna (vamshi25krishna@gmail.com).

Intention to publish date

31/05/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

28/05/2020: Trial's existence confirmed by Institutional Ethics Committee, All India Institute of Medical Sciences, Bhubaneswar.