Ignite Creation Date:
2024-07-17 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468488
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-05-26
Brief Title:
Impact of Drainless Donor Abdominal Site in Deep Inferior Epigastric Perforator DIEP Flap on Complications and Duration of Hospital Stay
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Impact of Drainless Donor Abdominal Site in Deep Inferior Epigastric Perforator DIEP Flap on Complications and Duration of Hospital Stay
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Inserting surgical drains is an ancient approach used across different specialties because of its many advantages such as discharge of fluid accumulation appraising and qualifying drain capacities lowering infection percentages and eliminating dead space
Most commonly abdominal closed-suction drains are used following autologous breast reconstruction with a DIEP flap to prevent donor site complications such as seroma hematoma and wound dehiscence Although abdominal drains are effective in impeding accumulation they are a potential portal for infection Furthermore they restrict patient mobility are cumbersome require time-consuming care upon discharge potentially increase inpatient stay and ultimately resulting in impaired health-care costs In the context of an Enhanced Rapid Protocol ERP not placing abdominal drains would be a step forward This involves using 34quilting sutures34 to close the dead space after flap prelevation Quilting sutures are placed between the subcutaneous tissues of the abdominal flap and the underlying fascia of the rectus abdominis muscle and aim to minimizes the shearing forces and collapse the death space without the use of drains Progressive tension sutures were first described in 2000 in a retrospective paper on cosmetic abdominoplasty patients Since then their procedure has been analysed and adapted by many authors and applied in perforator-based abdominal flaps for breast reconstruction
Despite the drainless approach is well known in the literature for cosmetic abdominoplasty procedures prospective clinical investigations to encourage the drainless approach in DIEP flap reconstruction is lacking Therefore we want to set up a prospective study to make a comparison between the outcomes succeeding donor site closure after DIEP flap harvesting with AD or without W-AD the use of abdominal drains and investigate whether there is a correlation between the use of drains and the length of hospital stay Secondary outcomes involve the complication rate of seroma hematoma and dehiscence analysis of abdominal drain output and postoperative recovery including pain and follow-up complications as described above
Most commonly abdominal closed-suction drains are used following autologous breast reconstruction with a DIEP flap to prevent donor site complications such as seroma hematoma and wound dehiscence Although abdominal drains are effective in impeding accumulation they are a potential portal for infection Furthermore they restrict patient mobility are cumbersome require time-consuming care upon discharge potentially increase inpatient stay and ultimately resulting in impaired health-care costs In the context of an Enhanced Rapid Protocol ERP not placing abdominal drains would be a step forward This involves using 34quilting sutures34 to close the dead space after flap prelevation Quilting sutures are placed between the subcutaneous tissues of the abdominal flap and the underlying fascia of the rectus abdominis muscle and aim to minimizes the shearing forces and collapse the death space without the use of drains Progressive tension sutures were first described in 2000 in a retrospective paper on cosmetic abdominoplasty patients Since then their procedure has been analysed and adapted by many authors and applied in perforator-based abdominal flaps for breast reconstruction
Despite the drainless approach is well known in the literature for cosmetic abdominoplasty procedures prospective clinical investigations to encourage the drainless approach in DIEP flap reconstruction is lacking Therefore we want to set up a prospective study to make a comparison between the outcomes succeeding donor site closure after DIEP flap harvesting with AD or without W-AD the use of abdominal drains and investigate whether there is a correlation between the use of drains and the length of hospital stay Secondary outcomes involve the complication rate of seroma hematoma and dehiscence analysis of abdominal drain output and postoperative recovery including pain and follow-up complications as described above
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None