Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-28 @ 2:22 AM
Study NCT ID:
NCT00859157
Status:
COMPLETED
Last Update Posted:
2017-06-21
First Post:
2009-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain After Tumescent Mastectomy or Standard Mastectomy in Women With Stage I, Stage II, or Stage III Breast Cancer
Sponsor:
University of California, Davis
Organization:
Study Overview
Official Title:
Tumescent Mastectomy: A Prospective Comparison to Standard Mastectomy Technique
Status:
COMPLETED
Status Verified Date:
2017-06
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:
RATIONALE: New surgery techniques may lessen pain after breast surgery. It is not yet known whether tumescent mastectomy or standard mastectomy results in less pain in women with breast cancer.
PURPOSE: This clinical trial is studying pain after tumescent mastectomy compared with pain after standard mastectomy in women with stage I, stage II, or stage III breast cancer.
PURPOSE: This clinical trial is studying pain after tumescent mastectomy compared with pain after standard mastectomy in women with stage I, stage II, or stage III breast cancer.
Detailed Description:
OBJECTIVES:
Primary
* To compare post-operative pain after tumescent vs standard mastectomy in women with stage I-III breast cancer.
Secondary
* To compare the total time of operation from incision to completion of wound closure.
* To compare the time of operation from first incision to completion of skin flaps.
* To compare the total estimated blood loss.
* To compare the number of days the Jackson-Pratt drain is left in place under skin flaps with wound drainage \> 30 mL/24 hours.
* To compare the incidence of wound complications such as skin necrosis, hematoma, cellulitis, abscess, and seroma between groups.
OUTLINE: Patients are grouped according to which surgeon provided their evaluation and treatment recommendations.
* Group 1: Patients undergo standard mastectomy.
* Group 2: Patients undergo tumescent mastectomy. All patients receive standardized post-operative pain management comprising morphine sulfate for analgesia or an equivalent dose of hydromorphone hydrochloride for 24 hours following surgery. Patients then receive 1-2 oral acetaminophen/oxycodone hydrochloride combination tablets (or a comparable amount of another narcotic/acetaminophen combination) every 6 hours as needed. Pain is assessed using the Short-form McGill Pain Questionnaire (SF-MPQ).
Primary
* To compare post-operative pain after tumescent vs standard mastectomy in women with stage I-III breast cancer.
Secondary
* To compare the total time of operation from incision to completion of wound closure.
* To compare the time of operation from first incision to completion of skin flaps.
* To compare the total estimated blood loss.
* To compare the number of days the Jackson-Pratt drain is left in place under skin flaps with wound drainage \> 30 mL/24 hours.
* To compare the incidence of wound complications such as skin necrosis, hematoma, cellulitis, abscess, and seroma between groups.
OUTLINE: Patients are grouped according to which surgeon provided their evaluation and treatment recommendations.
* Group 1: Patients undergo standard mastectomy.
* Group 2: Patients undergo tumescent mastectomy. All patients receive standardized post-operative pain management comprising morphine sulfate for analgesia or an equivalent dose of hydromorphone hydrochloride for 24 hours following surgery. Patients then receive 1-2 oral acetaminophen/oxycodone hydrochloride combination tablets (or a comparable amount of another narcotic/acetaminophen combination) every 6 hours as needed. Pain is assessed using the Short-form McGill Pain Questionnaire (SF-MPQ).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: